Trial Title:
A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)
NCT ID:
NCT06401330
Condition:
Stage I Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
Conditions: Official terms:
Neoplasms
Wilms Tumor
Dactinomycin
Cyclophosphamide
Carboplatin
Doxorubicin
Liposomal doxorubicin
Irinotecan
Etoposide
Vincristine
Etoposide phosphate
Daunorubicin
Podophyllotoxin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo bone scan
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm IIB (M)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm IX-Upfront/Delayed (MVI)
Arm group label:
Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage III, Arm X-Upfront/Delayed (M)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IV-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm VB-Upfront-Delayed (M)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Arm X-Upfront-Delayed (M)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm II (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm IV (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm IX (MVI)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VII (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm X (M)
Arm group label:
Stage IV Lung Metastases Arm II (DD-4A, M)
Arm group label:
Stage IV Lung Metastases Arm III (DD-4A, MVI)
Other name:
Bone Scintigraphy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Given IV
Arm group label:
Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Other name:
Blastocarb
Other name:
Carboplat
Other name:
Carboplatin Hexal
Other name:
Carboplatino
Other name:
Carboplatinum
Other name:
Carbosin
Other name:
Carbosol
Other name:
Carbotec
Other name:
CBDCA
Other name:
Displata
Other name:
Ercar
Other name:
JM-8
Other name:
JM8
Other name:
Nealorin
Other name:
Novoplatinum
Other name:
Paraplatin
Other name:
Paraplatin AQ
Other name:
Paraplatine
Other name:
Platinwas
Other name:
Ribocarbo
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Stage I, Arm I (EE-4A)
Arm group label:
Stage II, Arm I (EE-4A)
Arm group label:
Stage II, Arm II (EE-4A, DD-4A)
Arm group label:
Stage II, Arm III (EE-4A, VIVA)
Arm group label:
Stage III, Arm I (DD-4A, EE-4A)
Arm group label:
Stage III, Arm I-Upfront/Delayed (DD-4A, EE-4A)
Arm group label:
Stage III, Arm II (DD-4A)
Arm group label:
Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm IIB (M)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm IX-Upfront/Delayed (MVI)
Arm group label:
Stage III, Arm V-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VA-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VB-Upfront/Delayed (M)
Arm group label:
Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage III, Arm X-Upfront/Delayed (M)
Arm group label:
Stage IV Arm I-Upfront-Delayed (DD-4A, EE-4A)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IV-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm V-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VA-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VB-Upfront-Delayed (M)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Arm X-Upfront-Delayed (M)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm II (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm IV (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm IX (MVI)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VII (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm X (M)
Arm group label:
Stage IV Lung Metastases Arm I (DD-4A)
Arm group label:
Stage IV Lung Metastases Arm II (DD-4A, M)
Arm group label:
Stage IV Lung Metastases Arm III (DD-4A, MVI)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Given IV
Arm group label:
Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm IIB (M)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm IX-Upfront/Delayed (MVI)
Arm group label:
Stage III, Arm VB-Upfront/Delayed (M)
Arm group label:
Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage III, Arm X-Upfront/Delayed (M)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm VB-Upfront-Delayed (M)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Arm X-Upfront-Delayed (M)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm II (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm IV (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VII (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm X (M)
Arm group label:
Stage IV Lung Metastases Arm II (DD-4A, M)
Arm group label:
Stage IV Lung Metastases Arm III (DD-4A, MVI)
Other name:
(-)-Cyclophosphamide
Other name:
2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
Other name:
Asta B 518
Other name:
B 518
Other name:
B-518
Other name:
B518
Other name:
Carloxan
Other name:
Ciclofosfamida
Other name:
Ciclofosfamide
Other name:
Cicloxal
Other name:
Clafen
Other name:
Claphene
Other name:
CP monohydrate
Other name:
CTX
Other name:
CYCLO-cell
Other name:
Cycloblastin
Other name:
Cycloblastine
Other name:
Cyclophospham
Other name:
Cyclophosphamid monohydrate
Other name:
Cyclophosphamide Monohydrate
Other name:
Cyclophosphamidum
Other name:
Cyclophosphan
Other name:
Cyclophosphane
Other name:
Cyclophosphanum
Other name:
Cyclostin
Other name:
Cyclostine
Other name:
Cytophosphan
Other name:
Cytophosphane
Other name:
Cytoxan
Other name:
Fosfaseron
Other name:
Genoxal
Other name:
Genuxal
Other name:
Ledoxina
Other name:
Mitoxan
Other name:
Neosar
Other name:
Revimmune
Other name:
Syklofosfamid
Other name:
WR 138719
Other name:
WR- 138719
Other name:
WR-138719
Other name:
WR138719
Intervention type:
Biological
Intervention name:
Dactinomycin
Description:
Given IV
Arm group label:
Stage I, Arm I (EE-4A)
Arm group label:
Stage II, Arm I (EE-4A)
Arm group label:
Stage II, Arm II (EE-4A, DD-4A)
Arm group label:
Stage II, Arm III (EE-4A, VIVA)
Arm group label:
Stage III, Arm I (DD-4A, EE-4A)
Arm group label:
Stage III, Arm I-Upfront/Delayed (DD-4A, EE-4A)
Arm group label:
Stage III, Arm II (DD-4A)
Arm group label:
Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm IIB (M)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm IX-Upfront/Delayed (MVI)
Arm group label:
Stage III, Arm V-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VA-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VB-Upfront/Delayed (M)
Arm group label:
Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm X-Upfront/Delayed (M)
Arm group label:
Stage IV Arm I-Upfront-Delayed (DD-4A, EE-4A)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IV-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm V-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VA-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VB-Upfront-Delayed (M)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm X-Upfront-Delayed (M)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm II (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm IV (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm IX (MVI)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VII (DD-4A, M)
Arm group label:
Stage IV Lung Metastases Arm I (DD-4A)
Arm group label:
Stage IV Lung Metastases Arm II (DD-4A, M)
Arm group label:
Stage IV Lung Metastases Arm III (DD-4A, MVI)
Other name:
Actinomycin A IV
Other name:
Actinomycin C1
Other name:
Actinomycin D
Other name:
Actinomycin I1
Other name:
Actinomycin IV
Other name:
Actinomycin X 1
Other name:
Actinomycin-[thr-val-pro-sar-meval]
Other name:
Cosmegen
Other name:
DACT
Other name:
Dactinomycine
Other name:
Lyovac Cosmegen
Other name:
Meractinomycin
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Given IV
Arm group label:
Stage II, Arm II (EE-4A, DD-4A)
Arm group label:
Stage II, Arm III (EE-4A, VIVA)
Arm group label:
Stage III, Arm I-Upfront/Delayed (DD-4A, EE-4A)
Arm group label:
Stage III, Arm II (DD-4A)
Arm group label:
Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm IIB (M)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm V-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VA-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VB-Upfront/Delayed (M)
Arm group label:
Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage III, Arm X-Upfront/Delayed (M)
Arm group label:
Stage IV Arm I-Upfront-Delayed (DD-4A, EE-4A)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IV-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm V-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VA-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VB-Upfront-Delayed (M)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Arm X-Upfront-Delayed (M)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm II (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm IV (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm IX (MVI)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VII (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm X (M)
Arm group label:
Stage IV Lung Metastases Arm I (DD-4A)
Arm group label:
Stage IV Lung Metastases Arm II (DD-4A, M)
Arm group label:
Stage IV Lung Metastases Arm III (DD-4A, MVI)
Other name:
Adriablastin
Other name:
Hydroxydaunomycin
Other name:
Hydroxyl Daunorubicin
Other name:
Hydroxyldaunorubicin
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Given IV
Arm group label:
Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm IIB (M)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm IX-Upfront/Delayed (MVI)
Arm group label:
Stage III, Arm VB-Upfront/Delayed (M)
Arm group label:
Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage III, Arm X-Upfront/Delayed (M)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IV-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm VB-Upfront-Delayed (M)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Arm X-Upfront-Delayed (M)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm II (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm IV (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm IX (MVI)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VII (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm X (M)
Arm group label:
Stage IV Lung Metastases Arm II (DD-4A, M)
Arm group label:
Stage IV Lung Metastases Arm III (DD-4A, MVI)
Other name:
Demethyl Epipodophyllotoxin Ethylidine Glucoside
Other name:
EPEG
Other name:
Lastet
Other name:
Toposar
Other name:
Vepesid
Other name:
VP 16
Other name:
VP 16-213
Other name:
VP 16213
Other name:
VP-16
Other name:
VP-16-213
Other name:
VP-16213
Other name:
VP16
Other name:
VP16213
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Given IV
Arm group label:
Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IX-Upfront/Delayed (MVI)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm IX (MVI)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Arm group label:
Stage IV Lung Metastases Arm II (DD-4A, M)
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Stage I, Arm I (EE-4A)
Arm group label:
Stage II, Arm I (EE-4A)
Arm group label:
Stage II, Arm II (EE-4A, DD-4A)
Arm group label:
Stage II, Arm III (EE-4A, VIVA)
Arm group label:
Stage III, Arm I (DD-4A, EE-4A)
Arm group label:
Stage III, Arm I-Upfront/Delayed (DD-4A, EE-4A)
Arm group label:
Stage III, Arm II (DD-4A)
Arm group label:
Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm IIB (M)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm IX-Upfront/Delayed (MVI)
Arm group label:
Stage III, Arm V-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VA-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VB-Upfront/Delayed (M)
Arm group label:
Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage III, Arm X-Upfront/Delayed (M)
Arm group label:
Stage IV Arm I-Upfront-Delayed (DD-4A, EE-4A)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IV-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm V-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VA-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VB-Upfront-Delayed (M)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Arm X-Upfront-Delayed (M)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm II (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm IV (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm IX (MVI)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VII (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm X (M)
Arm group label:
Stage IV Lung Metastases Arm I (DD-4A)
Arm group label:
Stage IV Lung Metastases Arm III (DD-4A, MVI)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Nephrectomy
Description:
Undergo nephrectomy
Arm group label:
Stage I, Arm II (nephrectomy)
Intervention type:
Other
Intervention name:
Patient Observation
Description:
Undergo observation
Arm group label:
Stage I, Arm I (EE-4A)
Arm group label:
Stage I, Arm II (nephrectomy)
Other name:
Active Surveillance
Other name:
deferred therapy
Other name:
expectant management
Other name:
Observation
Other name:
Watchful Waiting
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm IIB (M)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm IX-Upfront/Delayed (MVI)
Arm group label:
Stage III, Arm VB-Upfront/Delayed (M)
Arm group label:
Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage III, Arm X-Upfront/Delayed (M)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IV-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm VB-Upfront-Delayed (M)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Arm X-Upfront-Delayed (M)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm II (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm IV (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm IX (MVI)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VII (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm X (M)
Arm group label:
Stage IV Lung Metastases Arm II (DD-4A, M)
Arm group label:
Stage IV Lung Metastases Arm III (DD-4A, MVI)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Procedure
Intervention name:
Ultrasound Imaging
Description:
Undergo ultrasound
Arm group label:
Stage I, Arm I (EE-4A)
Arm group label:
Stage II, Arm I (EE-4A)
Arm group label:
Stage II, Arm II (EE-4A, DD-4A)
Arm group label:
Stage II, Arm III (EE-4A, VIVA)
Arm group label:
Stage III, Arm I (DD-4A, EE-4A)
Arm group label:
Stage III, Arm I-Upfront/Delayed (DD-4A, EE-4A)
Arm group label:
Stage III, Arm II (DD-4A)
Arm group label:
Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm IIB (M)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm IX-Upfront/Delayed (MVI)
Arm group label:
Stage III, Arm V-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VA-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VB-Upfront/Delayed (M)
Arm group label:
Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage III, Arm X-Upfront/Delayed (M)
Arm group label:
Stage IV Arm I-Upfront-Delayed (DD-4A, EE-4A)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IV-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm V-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VA-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VB-Upfront-Delayed (M)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Arm X-Upfront-Delayed (M)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm II (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm IV (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm IX (MVI)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VII (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm X (M)
Arm group label:
Stage IV Lung Metastases Arm I (DD-4A)
Arm group label:
Stage IV Lung Metastases Arm II (DD-4A, M)
Arm group label:
Stage IV Lung Metastases Arm III (DD-4A, MVI)
Other name:
2-Dimensional Grayscale Ultrasound Imaging
Other name:
2-Dimensional Ultrasound Imaging
Other name:
2D-US
Other name:
Ultrasonography
Other name:
Ultrasound
Other name:
Ultrasound Test
Other name:
Ultrasound, Medical
Other name:
US
Intervention type:
Drug
Intervention name:
Vincristine
Description:
Given IV
Arm group label:
Stage I, Arm I (EE-4A)
Arm group label:
Stage II, Arm I (EE-4A)
Arm group label:
Stage II, Arm II (EE-4A, DD-4A)
Arm group label:
Stage II, Arm III (EE-4A, VIVA)
Arm group label:
Stage III, Arm I (DD-4A, EE-4A)
Arm group label:
Stage III, Arm I-Upfront/Delayed (DD-4A, EE-4A)
Arm group label:
Stage III, Arm II (DD-4A)
Arm group label:
Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm IIB (M)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm IX-Upfront/Delayed (MVI)
Arm group label:
Stage III, Arm V-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VA-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage III, Arm X-Upfront/Delayed (M)
Arm group label:
Stage IV Arm I-Upfront-Delayed (DD-4A, EE-4A)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IV-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm V-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VA-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VB-Upfront-Delayed (M)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Arm X-Upfront-Delayed (M)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm II (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm IV (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm IX (MVI)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VII (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm X (M)
Arm group label:
Stage IV Lung Metastases Arm I (DD-4A)
Arm group label:
Stage IV Lung Metastases Arm II (DD-4A, M)
Arm group label:
Stage IV Lung Metastases Arm III (DD-4A, MVI)
Other name:
LCR
Other name:
Leurocristine
Other name:
VCR
Other name:
Vincrystine
Intervention type:
Procedure
Intervention name:
X-Ray Imaging
Description:
Undergo X-ray
Arm group label:
Stage I, Arm I (EE-4A)
Arm group label:
Stage II, Arm I (EE-4A)
Arm group label:
Stage II, Arm II (EE-4A, DD-4A)
Arm group label:
Stage II, Arm III (EE-4A, VIVA)
Arm group label:
Stage III, Arm I (DD-4A, EE-4A)
Arm group label:
Stage III, Arm I-Upfront/Delayed (DD-4A, EE-4A)
Arm group label:
Stage III, Arm II (DD-4A)
Arm group label:
Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Arm group label:
Stage III, Arm IIA (MVI)
Arm group label:
Stage III, Arm IIB (M)
Arm group label:
Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm IX-Upfront/Delayed (MVI)
Arm group label:
Stage III, Arm V-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VA-Upfront/Delayed (DD-4A)
Arm group label:
Stage III, Arm VB-Upfront/Delayed (M)
Arm group label:
Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI)
Arm group label:
Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Arm group label:
Stage III, Arm VIII-Upfront/Delayed (UH-3)
Arm group label:
Stage III, Arm X-Upfront/Delayed (M)
Arm group label:
Stage IV Arm I-Upfront-Delayed (DD-4A, EE-4A)
Arm group label:
Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Arm group label:
Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm IV-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm IX-Upfront-Delayed (MVI)
Arm group label:
Stage IV Arm V-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VA-Upfront-Delayed (DD-4A)
Arm group label:
Stage IV Arm VB-Upfront-Delayed (M)
Arm group label:
Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Arm group label:
Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Arm group label:
Stage IV Arm VIII-Upfront-Delayed (UH-3)
Arm group label:
Stage IV Arm X-Upfront-Delayed (M)
Arm group label:
Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm II (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm IV (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm IX (MVI)
Arm group label:
Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Arm group label:
Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Arm group label:
Stage IV Extrapulmonary Arm VII (DD-4A, M)
Arm group label:
Stage IV Extrapulmonary Arm VIII (UH-3)
Arm group label:
Stage IV Extrapulmonary Arm X (M)
Arm group label:
Stage IV Lung Metastases Arm I (DD-4A)
Arm group label:
Stage IV Lung Metastases Arm II (DD-4A, M)
Arm group label:
Stage IV Lung Metastases Arm III (DD-4A, MVI)
Other name:
Conventional X-Ray
Other name:
Diagnostic Radiology
Other name:
Medical Imaging, X-Ray
Other name:
Plain film radiographs
Other name:
Radiographic Imaging
Other name:
Radiographic imaging procedure (procedure)
Other name:
Radiography
Other name:
RG
Other name:
Static X-Ray
Other name:
X-Ray
Summary:
This phase III trial studies using risk factors in determining treatment for children
with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common
type of kidney cancer in children, and FHWT is the most common subtype. Previous large
clinical trials have established treatment plans that are likely to cure most children
with FHWT, however some children still have their cancer come back (called relapse) and
not all survive. Previous research has identified features of FHWT that are associated
with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer
coming back after treatment. Using results of tumor histology tests, biology tests, and
response to therapy may be able to improve treatment for children with FHWT.
Detailed description:
PRIMARY OBJECTIVES:
I. To maintain event-free survival (EFS) for Stage I favorable histology Wilms tumor
(FHWT) patients without adverse biology who are also (1) 2 to < 4 years of age, OR (2)
age < 2 years with tumor weight of 550 grams or more, OR (3) age 4+ years with epithelial
histology subtype while reducing post-nephrectomy therapy from vincristine, actinomycin
(EE-4A) to Nephrectomy Only. (Stage I Nephrectomy Only Stratum 2) II. To improve EFS for
Stage I FHWT patients with age < 2 years AND nephrectomy weight < 550g AND whose tumors
have adverse biology by treating with EE-4A instead of Nephrectomy Only. (Stage I EE-4A
Stratum 3) III. To evaluate whether addition of vincristine and irinotecan to standard
EE-4A (novel vincristine, actinomycin, irinotecan [Regimen VIVA]) is non-inferior to
vincristine, actinomycin, doxorubicin (DD-4A) in terms of EFS among Stage II FHWT
patients whose tumors demonstrate adverse biology. (Stage II: VIVA versus [vs] DD-4A
Randomization) IV. To evaluate whether omission of doxorubicin (EE-4A) is non-inferior to
historical DD-4A in Stage III FHWT patients with standard biology or post-therapy
blastemal predominance. (Stage III: EE-4A) V. To demonstrate the non-inferiority of
vincristine, actinomycin, doxorubicin, cyclophosphamide, etoposide and irinotecan
(Regimen MVI) to vincristine, dactinomycin, doxorubicin, cyclophosphamide and etoposide
(Regimen M) in the treatment of Stage III FHWT patients whose tumors exhibit adverse
biology (post-chemotherapy blastemal predominance excluded). (Stage III: Regimen MVI vs
Regimen M Randomization) VI. To demonstrate the non-inferiority of Regimen MVI to Regimen
M in the treatment of Stage IV FHWT patients with adverse biology, slow incomplete lung
response (SIR), or extrapulmonary metastases (EPM) (post-therapy blastemal predominance
excluded). (Stage IV: Regimen MVI vs Regimen M Randomization) VII. To demonstrate the
superiority of vincristine, doxorubicin, cyclophosphamide, etoposide, carboplatin and
irinotecan (Regimen UH-3) vs historical DD-4A or Regimen M in treatment of Stage III or
IV FHWT patients with blastemal predominance at delayed nephrectomy. (Stage III-IV: UH-3
(Blastemal Predominance)
SECONDARY OBJECTIVES:
I. To describe outcomes for Stage I FHWT patients without adverse biology who are either
less than 4 years of age OR 4+ years of age with epithelial subtype who are treated with
Nephrectomy Only and assess consistency with a matched historical control from the prior
Children's Oncology Group (COG) therapeutic era. (Stage I: Nephrectomy Only) II. To
describe outcomes for Stage I FHWT patients with adverse biology OR age > 4 and not
epithelial subtype who are treated with post-nephrectomy EE-4A and assess consistency
with a matched historical control from the prior COG therapeutic era. (Stage I: EE-4A)
III. To describe overall survival in the cohort of modified very low risk (mVLR) patients
who relapse following treatment with nephrectomy only and are assigned at relapse to
DD-4A (if presumed or confirmed favorable histology Wilms tumor at relapse) or UH-3 (if
evidence of anaplasia at relapse). (Stage I: Nephrectomy Only Relapse) IV. To describe
outcomes for Stage II FHWT patients without adverse biology who are treated with
post-nephrectomy EE-4A and assess consistency with a matched historical control from the
prior COG therapeutic era. (Stage II: EE-4A) V. To compare outcomes of Stage II FHWT
patients whose tumors are negative for combined loss of heterozygosity (LOH) but positive
for 1q gain who are randomized to VIVA vs DD-4A on AREN2231 against historically matched
patients treated with EE-4A during the prior COG therapeutic era. (Stage II VIVA vs DD-4A
Stratum 1) VI. To compare outcomes of Stage II FHWT patients whose tumors are positive
for combined LOH 1p AND 16q and who are randomized to VIVA vs DD-4A on AREN2231 against
historically matched patients treated with DD-4A during the prior COG therapeutic era.
(Stage II VIVA vs DD-4A Stratum 2) VII. To compare outcomes of Stage III FHWT patients
whose tumors have adverse biology other than combined LOH and who are randomized to
Regimen MVI vs Regimen M on AREN2231 against historically matched patients treated with
DD-4A during the prior COG therapeutic era (post-chemotherapy blastemal predominance
excluded). (Stage III Regimen MVI vs Regimen M Stratum 1) VIII. To compare outcomes of
Stage III FHWT patients whose tumors have combined LOH and who are randomized to Regimen
MVI vs Regimen M on AREN2231 against historically matched patients treated with Regimen M
during the prior COG therapeutic era (post-chemotherapy blastemal predominance excluded).
(Stage III Regimen MVI vs Regimen M Stratum 2) IX. To describe outcomes for Stage IV FHWT
patients with rapid complete response of lung only metastases and no adverse biology who
are treated with DD-4A on AREN2231 and assess consistency with a matched historical
control from the prior COG therapeutic era (post-chemotherapy blastemal predominance
excluded). (Stage IV: DD-4A) X. To compare outcomes of Stage IV lung only patients with
either combined LOH 1p AND 16q or SIR who are randomized to Regimen MVI vs Regimen M on
AREN2231 against historically matched patients treated with Regimen M during the prior
COG therapeutic era (post-chemotherapy blastemal predominance excluded). (Stage IV
Regimen MVI vs Regimen M Stratum 1) XI. To compare outcomes of Stage IV lung only rapid
complete response (RCR) patients without combined LOH 1p AND 16q who are positive for
other adverse biological factors and who are randomized to Regimen MVI vs Regimen M on
AREN2231 against historically matched patients treated with DD-4A during the prior COG
therapeutic era (post-chemotherapy blastemal predominance excluded). (Stage IV Regimen
MVI vs Regimen M Stratum 2) XII. To compare outcomes of Stage IV patients with
extrapulmonary metastases (EPM) who are randomized to Regimen MVI vs Regimen M on
AREN2231 against historically matched patients treated with Regimen M during the prior
COG therapeutic era (post-chemotherapy blastemal predominance excluded). (Stage IV
Regimen MVI vs Regimen M Stratum 3) XIII. To report a pooled comparison of Regimen MVI vs
Regimen M in Stage III or Stage IV randomized patients. (Stage III-IV Regimen MVI vs
Regimen M) XIV. To compare outcomes of Stage III or IV FHWT patients with blastemal
predominance at delayed nephrectomy who are treated with Regimen UH-3 on AREN2231 vs a
historically matched cohort that received DD-4A in the prior COG therapeutic era. (Stage
III-IV UH-3 Stratum 1) XV. To compare outcomes of Stage III or IV FHWT patients with
blastemal predominance at delayed nephrectomy who are treated with Regimen UH-3 on
AREN2231 vs a historically matched cohort that received Regimen M in the prior COG
therapeutic era. (Stage III-IV UH-3 Stratum 2) XVI. To describe outcomes of Stage III or
IV FHWT patients with delayed nephrectomy occurring after the start of Cycles 3 or 4
(super delayed) who are assigned to Regimen M or continued DD4A. (Stage III-IV Super
Delayed Nephrectomy)
EXPLORATORY OBJECTIVES:
I. To determine the impact of imaging schedule and modality (chest x-ray [CXR],
ultrasound [US], versus computed tomography/magnetic resonance imaging [CT/MRI], versus
clinical symptoms) on relapse, timing of detection of relapse, burden of disease at
relapse (as assessed by retrospective central imaging review), as well as impact on
survival.
II. To analyze the impact of radiologically determined pulmonary tumor burden on
outcomes.
III. To assess whether imaging modality (ultrasound, CT, MRI with or without hepatocyte
specific contrast agent) at diagnosis is associated with detection of increased number of
liver metastases, and whether modality choice impacts surgery and/or radiation planning
for liver metastases.
IV. To accurately describe the responses of extrapulmonary metastases to the various
therapeutic modalities (chemotherapy, radiation therapy, and surgery) through central
review of institutional imaging at various stages of treatment, and to correlate
institutionally interpreted radiologic response interpretations with central review.
V. To describe the association of the number of anatomically relevant and pathologically
confirmed lymph nodes sampled and percent of positive lymph nodes (LNs) on EFS and
overall survival [OS].
VI. To document the surgical and/or medical rationale and approach for biopsy (including
type of biopsy, number of biopsies, and site of biopsy) for all patients who are treated
with the approach of initial biopsy and delayed nephrectomy.
VII. To describe sites of recurrence for patients with liver metastases according to the
surgery and/or radiation therapy administered for residual liver lesions at Week 6 and
12.
VIII. To increase the number of patients eligible to avoid lung radiation therapy (RT) by
encouraging resection of residual pulmonary nodules for patients defined as Stage IV FHWT
with standard biology and who have 1-3 residual pulmonary nodules on imaging after Cycle
2, by omitting lung RT for those who are found to have no viable tumor in resected
nodules.
IX. To describe whether residual lung lesions at end of therapy are associated with
relapse.
X. To improve the reliability of data derived from central surgical review through the
implementation of a standardized operative note.
XI. To describe the treatment, perioperative morbidity and outcome of patients noted to
have inferior vena cava (IVC) tumor thrombus at time of diagnosis, including surgical
approach, pathology findings and specific radiation therapy received.
XII. To determine the feasibility of employing intensity modulated radiation therapy
(IMRT) with central quality assurance (QA) monitoring within the prescribed time frame.
XIII. To determine the lung tumor and liver tumor control rate using intensity modulated
radiation therapy (IMRT) and/or proton therapy and compare it to standard 3-dimensional
radiotherapy in the current study and the AREN0533 study.
XIV. To determine the flank and abdominal tumor control rates in children with Stage IV
FHWT who received abdominal radiotherapy after 2 cycles of chemotherapy in this study
(delayed abdominal radiation) and compare it to AREN0533 study where abdominal
radiotherapy was performed within 2 weeks of nephrectomy (upfront abdominal radiation).
XV. To compare abdominal relapse according to protocol-recommended radiotherapy fields
(flank vs. whole abdominal) in the current study and compare it to the abdominal relapse
according to radiotherapy fields (flank vs. whole abdominal) in the AREN0532 and AREN0533
studies.
XVI. To determine the impact of radiotherapy on local and distant control rates for EPM
sites and compare them to EPM sites not receiving radiation.
XVII. To describe the rate and severity of recurrent hepatotoxicity in patients who
undergo re-introduction of chemotherapy after experiencing hepatopathy.
XVIII. To collect serial blood and urine samples to bank for future research studies.
OUTLINE:
STAGE I FHWT: Patients < 4 years old at diagnosis or with epithelial FHWT, regardless of
age, undergo observation until disease relapse. At the time of disease relapse, patients
with adverse biology are assigned to Arm I, and patients with standard biology are
assigned to Arm II. Patients ≥ 4 years of age at diagnosis without epithelial FHWT are
assigned to Arm I without
- ARM I: Patients receive the EE-4A regimen: Dactinomycin intravenously (IV) over 1-5
or 10-15 minutes on day 1 and vincristine IV on days 1, 8, & 15 of each cycle.
Treatment repeats every 21 days for 3 cycles in the absence of disease progression
or unacceptable toxicity. Patients then receive dactinomycin IV over 1-5 or 10-15
minutes on day 1 and vincristine IV on day 1 of each cycle. Treatment repeats every
21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
- ARM II: Patients undergo nephrectomy on study.
STAGE II FHWT: Patients receive one cycle of the EE-4A regimen as in STAGE I FHWT Arm I.
Patients with standard biology are assigned to Arm I below. Patients with adverse biology
are randomized to Arm II or Arm III below.
- ARM I: Patients receive six cycles of the EE-4A regimen as in STAGE I FHWT Arm I.
- ARM II: Patients receive cycles 2-9 of the DD-4A regimen: Dactinomycin IV over 1-5
or 10-15 minutes on day 1 of cycles 3, 5, 7, & 9, vincristine IV on days 1, 8, & 15
of cycles 2-3 and day 1 of cycles 4-8, irinotecan IV over 90 minutes daily on days
1-5 of cycles 2, 4, 6, & 8. Treatment repeats every 21 days for 8 cycles in the
absence of disease progression or unacceptable toxicity.
- ARM III: Patients receive cycles 2-9 of the VIVA regimen: Dactinomycin IV over 1-5
or 10-15 minutes on day 1 of cycles 3, 5, 7, and 9, vincristine IV on days 1, 8, and
15 of cycles 2-3 and day 1 of cycles 4-8, and doxorubicin IV over 3-15 minutes on
day 1 of cycles 2, 4, 6, & 8. Treatment repeats every 21 days for 8 cycles in the
absence of disease progression or unacceptable toxicity.
STAGE III FHWT: Patients able to undergo an upfront nephrectomy receive cycle 1 treatment
of the DD-4A regimen: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 and vincristine
IV on days 1, 8, and 15. Patients with standard biology are assigned to Arm I below.
Patients with adverse biology are assigned to Arm II below.
- ARM I: Patients receive cycles 2-7 of the EE-4A regimen as in STAGE I FHWT Arm I.
- ARM II: Patients receive cycle 2 treatment of the DD-4A regimen as in STAGE II FHWT
Arm II above.
- ARM IIA: Patients receive the MVI regimen: Vincristine IV on days 1, 8, & 15 of
cycle 3, days 8 & 15 of cycle 4, and day 1 of cycles 5 & 7-13, dactinomycin IV
over 1-5 or 10-15 minutes on day 1 of cycles 3, 7, 9, 11, & 13, doxorubicin IV
over 3-15 minutes on day 1 of cycles 3, 7, 9, 11, & 13, cyclophosphamide IV
over 15-30 minutes daily on days 1-5 of cycles 4 and 6, irinotecan IV over 90
minutes daily on days 1-5 of cycles 5, 8, 10 & 12, and etoposide IV over 60-120
minutes daily on days 1-5 of cycle 6. Treatment repeats every 21 days for 11
cycles in the absence of disease progression or unacceptable toxicity.
- ARM IIB: Patients receive the M regimen: Cyclophosphamide IV over 15-30 minutes
daily on days 1-5 of cycles 3, 4, 7, & 9, etoposide IV over 60-120 minutes
daily on days 1-5 of cycles 3, 4, 7, & 9, vincristine IV on days 8 & 15 of
cycles 3 & 4 and day 1 of cycles 5, 6, 8, 10, & 11, dactinomycin IV over 1-5 or
10-15 minutes on day 1 of cycles 5, 6, 8, 10, & 11, and doxorubicin IV over
3-15 minutes of cycles 5, 6, 8, 10, & 11. Treatment repeats every 21 days for 9
cycles in the absence of disease progression or unacceptable toxicity.
STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY): Patients receive cycles 1-2 of the
DD-4A regimen as in STAGE II FHWT and STAGE III FHWT Arm II above.
- PATIENTS ABLE TO UNDERGO A DELAYED NEPHRECTOMY AFTER CYCLE 2: Patients with standard
biology and low or intermediate risk histology are assigned to Arm I below. Patients
with high risk histology are assigned to Arm II below. Patients with adverse biology
are randomized to Arm III or Arm IV below.
- PATIENTS UNABLE TO UNDERGO A DELAYED NEPHRECTOMY AFTER CYCLE 2: Patients with
standard biology are assigned to Arm V below. Patients with adverse biology are
randomized to Arm VI or Arm VII below.
- ARM I: Patients receive cycles 3-7 of the EE-4A regimen as in STAGE I FHWT Arm I
above.
- ARM II: Patients receive the UH-3 regimen: Vincristine IV on days 1, 8, & 15 of
cycles 1, 5, 7, 10, & 13, and days 1 & 8 of cycles 3, 4, 8, & 11, doxorubicin IV
3-15 minutes on day 1 of cycles 1, 5, 7, 10, & 13, cyclophosphamide IV over 30-60
minutes on day 1 of cycles 1, 5, 7, 10, & 13, and days 1-4 of cycles 2, 6, 9, 12, &
14, carboplatin IV over 15-60 minutes on day 1 of cycles 2, 6, 9, 12, and 14,
etoposide IV over 60-120 minutes on days 1-4 of cycles 2, 6, 9, 12, & 14, and
irinotecan IV over 90 minutes on days 1-5 of cycles 3, 4, 8, & 11. Treatment repeats
every 21 days for 14 cycles in the absence of disease progression or unacceptable
toxicity.
- ARM III: Patients receive the MVI regimen as in STAGE III FHWT Arm IIA above.
- ARM IV: Patients receive the M regimen as in STAGE III FHWT Arm IIB above.
- ARM V: Patients receive cycles 3-4 of the DD-4A regimen as in STAGE II FHWT Arm II
above. Patients with low or intermediate risk histology without LOH 1p or 16q
genetic results are then assigned to Arm VA. Patients with low or intermediate risk
histology, positive lymph nodes, and 1p or 16q genetic results are then assigned to
Arm VB. Patients with high risk histology are assigned to Arm VIII below.
- ARM VA: Patients receive cycles 5-9 of the DD-4A regimen as in STAGE II FHWT
Arm II above.
- ARM VB: Patients receive the M regimen as in STAGE III FHWT Arm IIB above.
- ARM VI: Patients receive cycles 3-4 of the MVI regimen as in STAGE III FHWT Arm IIA
above. Patients with high risk histology after delayed nephrectomy in cycle 3 or 4
are assigned to Arm VIII. Patients with low or intermediate risk histology after
delayed nephrectomy in cycle 3 or 4 are assigned to Arm IX.
- ARM VII: Patients receive cycles 3-4 of the M regimen as in STAGE III FHWT Arm IIB
above. Patients with high risk histology after delayed nephrectomy in cycle 3 or 4
are assigned to Arm VIII. Patients with low or intermediate risk histology after
delayed nephrectomy in cycle 3 or 4 are assigned to Arm X.
- ARM VIII: Patients receive the UH-3 regimen as in STAGE III FHWT (UPFRONT
BIOPSY/DELAYED NEPHRECTOMY) Arm II above.
- ARM IX: Patients receive cycles 5-13 of the MVI regimen as in STAGE III FHWT Arm IIA
above.
- ARM X: Patients receive cycles 5-11 of the M regimen as in STAGE III FHWT Arm IIB
above.
STAGE IV FHWT LUNG METASTASES (UPFRONT NEPHRECTOMY): Patients receive cycles 1-2 of the
DD-4A regimen as in STAGE II FHWT and STAGE III FHWT Arm II above. Patients with standard
biology and rapid complete lung response (RCR) are assigned to Arm I below. Patients with
standard biology and slow incomplete lung response (SIR), or adverse biology are
randomized to Arm II or Arm III below.
- ARM I: Patients receive cycles 3-9 of the DD-4A regimen as in STAGE III FHWT
(UPFRONT BIOPSY/DELAYED NEPHRECTOMY) Arms V and VA above.
- ARM II: Patients receive the M regimen as in STAGE III FHWT Arm IIB above.
- ARM III: Patients receive the MVI regimen as in STAGE III FHWT Arm IIA above.
STAGE IV FHWT LUNG METASTASES (UPFRONT BIOPSY/DELAYED NEPHRECTOMY): Patients receive
cycles 1-2 of the DD-4A regimen as in STAGE II FHWT and STAGE III FHWT Arm II above.
- PATIENTS ABLE TO UNDERGO A DELAYED NEPHRECTOMY AFTER CYCLE 2: Patients with standard
biology, low or intermediate risk histology, and RCR are assigned to Arm I below.
Patients with high risk histology are assigned to Arm II below. Patients with
adverse biology and low or intermediate risk histology are randomized to Arm III or
Arm IV below.
- PATIENTS UNABLE TO UNDERGO A DELAYED NEPHRECTOMY AFTER CYCLE 2: Patients with
standard biology and RCR are assigned to Arm V below. Patients with standard biology
and SIR OR adverse biology and either SIR or RCR are randomized to Arm VI or Arm VI
below.
- ARM I: Patients receive cycles 3-7 of the EE-4A regimen as in STAGE I FHWT Arm I
above.
- ARM II: Patients receive the UH-3 regimen as in STAGE III FHWT (UPFRONT
BIOPSY/DELAYED NEPHRECTOMY) Arm II.
- ARM III: Patients receive the MVI regimen as in STAGE III FHWT Arm IIA above.
- ARM IV: Patients receive the M regimen as in STAGE III FHWT Arm IIB above.
- ARM V: Patients receive cycles 3-4 of the DD-4A regimen as in STAGE II FHWT Arm II
above. Patients with low or intermediate risk histology without LOH 1p or 16q
genetic results are then assigned to Arm VA. Patients with low or intermediate risk
histology, positive lymph nodes, and 1p or 16q genetic results are then assigned to
Arm VB. Patients with high risk histology are assigned to Arm VIII below.
- ARM VA: Patients receive cycles 5-9 of the DD-4A regimen as in STAGE II FHWT
Arm II above.
- ARM VB: Patients receive the M regimen as in STAGE III FHWT Arm IIB above.
- ARM VI: Patients receive cycles 3-4 of the MVI regimen as in STAGE III FHWT Arm IIA
above. Patients with high risk histology after delayed nephrectomy in cycle 3 or 4
are assigned to Arm VIII. Patients with low or intermediate risk histology after
delayed nephrectomy in cycle 3 or 4 are assigned to Arm IX.
- ARM VII: Patients receive cycles 3-4 of the M regimen as in STAGE III FHWT Arm IIB
above. Patients with high risk histology after delayed nephrectomy in cycle 3 or 4
are assigned to Arm VIII. Patients with low or intermediate risk histology after
delayed nephrectomy in cycle 3 or 4 are assigned to Arm X.
- ARM VIII: Patients receive the UH-3 regimen as in STAGE III FHWT (UPFRONT
BIOPSY/DELAYED NEPHRECTOMY) Arm II above.
- ARM IX: Patients receive cycles 5-13 of the MVI regimen as in STAGE III FHWT Arm IIA
above.
- ARM X: Patients receive cycles 5-11 of the M regimen as in STAGE III FHWT Arm IIB
above.
STAGE IV FHWT EXTRAPULMONARY METASTASES: Patients receive cycles 1-2 of the DD-4A regimen
as in STAGE II FHWT and STAGE III FHWT Arm II above.
PATIENTS ABLE TO UNDERGO UPFRONT NEPHRECTOMY: Patients are randomized to Arm I or II
below.
PATIENTS ABLE TO UNDERGO DELAYED NEPHRECTOMY AFTER CYCLE 2: Patients with low or
intermediate risk histology are randomized to Arm III or IV.
PATIENTS ABLE TO UNDERGO DELAYED NEPHRECTOMY AFTER CYCLE 2: Patients with high risk
histology are assigned to Arm V.
PATIENTS UNABLE TO UNDERGO DELAYED NEPHRECTOMY AFTER CYCLE 2: Patients are randomized to
Arm VI or VII.
- ARM I: Patients receive the MVI regimen as in STAGE III FHWT Arm IIA above.
- ARM II: Patients receive the M regimen as in STAGE III FHWT Arm IIB above.
- ARM III: Patients receive the MVI regimen as in STAGE III FHWT Arm IIA above.
- ARM IV: Patients receive the M regimen as in STAGE III FHWT Arm IIB above.
- ARM V: Patients receive the UH-3 regimen as in STAGE III FHWT (UPFRONT
BIOPSY/DELAYED NEPHRECTOMY) Arm II above.
- ARM VI: Patients receive cycles 3-4 of the MVI regimen as in STAGE III FHWT Arm IIA
above. Patients undergoing nephrectomy after cycles 3 or 4 and with low or
intermediate risk histology are assigned to Arm IX below. Patients undergoing
nephrectomy after cycles 3 or 4 and with high risk histology are assigned to Arm
VIII below
- ARM VII: Patients receive cycles 3-4 of the M regimen as in STAGE III FHWT Arm IIB
above. Patients undergoing nephrectomy after cycles 3 or 4 and with low or
intermediate risk histology are assigned to Arm X below. Patients undergoing
nephrectomy after cycles 3 or 4 and with high risk histology are assigned to Arm
VIII below.
- ARM VIII: Patients receive the UH-3 regimen as in STAGE III FHWT (UPFRONT
BIOPSY/DELAYED NEPHRECTOMY) Arm II above.
- ARM IX: Patients receive cycles 5-13 of the MVI regimen as in STAGE III FHWT Arm IIA
above.
- ARM X: Patients receive cycles 5-11 of the M regimen as in STAGE III FHWT Arm IIB
above.
- NOTE: Patients receiving EE-4A, DD-4A & VIVA regimens also undergo CT, CT/MRI,
ultrasound, and X-ray imaging throughout the trial. Patients receiving M, MVI &
UH3 regimens also undergo CT, CT/MRI, ultrasound, X-ray, and bone scan/positron
emission tomography (PET) scans throughout the trial.
After completion of study treatment, patients are followed for 10 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must be enrolled on APEC14B1 and consent to Part A - Eligibility Screening
prior to enrollment on AREN2231.
- Patients must be < 30 years old at enrollment.
- Patients with newly diagnosed Stage I-IV Favorable Histology Wilms Tumor confirmed
by central review and with a qualifying Initial Stratum Assignment on APEC14B1.
- Patients must receive a qualifying Initial Stratum Assignment on APEC14B1 by Day 14
post-diagnostic procedure (nephrectomy or biopsy), where that procedure is Day 0.
- Patients must enroll on AREN2231 by Day 14.
- Exceptions: If patient reaches Day 14 (post initial diagnostic nephrectomy or
biopsy) without receiving an Initial Stratum Assignment on APEC14B1, patient
will not be eligible for enrollment on AREN2231 unless all required materials
(reports and Case Report Forms and specimens) for an Initial Stratum Assignment
arrived by Day 7, but an Initial Stratum Assignment was not completed by Day
14. In these circumstances, after obtaining appropriate protocol consent, the
patient may proceed with treatment according to local institutional staging and
enroll within 5 calendar days of notification of the central Initial Stratum
Assignment being issued, only if the AREN2231 Initial Stratum Assignment is in
agreement with any treatment already initiated. If the Initial Stratum
Assignment is not in agreement with the local institution's assessment then the
patient will be ineligible for AREN2231.
- All sites must have sent or plan to send diagnostic tumor sample for molecular
testing through a Clinical Laboratory Improvement Act (CLIA)-certified (or
equivalent if outside of the United States [US]) laboratory that can detect Loss of
Heterozygosity (LOH) of chromosome 1p AND 16q, and gain of chromosome 1q. Patients
potentially eligible for mVLR must also have LOH of chromosome 11p15 included.
- Note: Patients are eligible for enrollment before these results are available;
however, molecular results must be returned and uploaded to APEC14B1 for
integration into risk stratification by the required timepoints (specific
timelines vary by treatment arm). Patients who do not have molecular results
available by the arm-specific timepoints may be taken off protocol therapy.
- Patients who have an upfront nephrectomy must have at least one lymph node sampled
and confirmed as a lymph node by central pathology review to be eligible.
- Note: Lymph node sampling will also be required at delayed nephrectomy.
Patients who do not have a lymph node sampled and confirmed as a lymph node by
central pathology review at delayed nephrectomy will be taken off protocol
therapy.
- Karnofsky performance status must be 50 for patients > 16 years of age and the
Lansky performance status must be 50 for patients ≤ 16 years of age.
- Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) OR direct bilirubin ≤ 3X
ULN for subjects with total bilirubin levels > 1.5 ULN (within 7 days prior to
enrollment).
- Aspartate aminotransferase (AST/serum glutamate oxaloacetic transaminase [SGOT]) OR
alanine transaminase (ALT/serum glutamic pyruvate transaminase [SGPT]) ≤ 3X ULN OR ≤
5 X ULN for patients with liver metastases (within 7 days prior to enrollment).
- Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50%
(within 7 days prior to enrollment)
- Note: This criteria only applies to patients centrally classified as Stage IV.
Stage II and III patients subsequently assigned to a doxorubicin arm will be
off protocol therapy if they do not meet this criteria at time of cardiac
function assessment.
- Known HIV-infected patients on effective anti-retroviral therapy with undetectable
viral load within 6 months are eligible for this trial.
- All patients and/or their parents or legal guardians must sign a written informed
consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met.
Exclusion Criteria:
- Patient with a diagnosis of Stage V Bilateral Wilms Tumor.
- Patients who in the opinion of the investigator are not able to comply with the
study procedures are not eligible.
- Patients with any uncontrolled, intercurrent illness including but not limited to
symptomatic congestive heart failure.
- Patients with Stage I FHWT who are < 4 years at enrollment with a known Wilms Tumor
predisposition syndrome are excluded from treatment on the mVLR (Nephrectomy Only)
arm.
- Note: These patients with any known Wilms Tumor predisposition syndrome may
enroll on other arms if they receive a qualifying Initial Stratum Assignment.
- Patients treated with partial nephrectomy at initial diagnosis are excluded from
mVLR (Nephrectomy Only) arm.
- Patients with lung metastases as the only metastatic site who already had complete
resection of all radiologically evident lung nodules, and have at least one nodule
confirmed pathologically as tumor.
- Please note: Those with lung metastases as the only metastatic site who have
complete resection of all radiologically evident lung nodules after enrollment
but prior to the lung imaging following Cycle 2 of DD-4A will be inevaluable
for lung assessment and subsequent stratum assignment and will, therefore, come
Off Protocol Therapy.
- Patients who have had prior tumor-directed chemotherapy or radiotherapy for the
current diagnosis except for therapy delivered for an emergent issue, as medically
indicated.
- Patients who will potentially require doxorubicin on this study and have previously
received doxorubicin for another diagnosis.
- Patients receiving concurrent chemotherapy for a different diagnosis.
- Female patients who are pregnant since fetal toxicities and teratogenic effects have
been noted for several of the study drugs. A pregnancy test is required for female
patients of childbearing potential.
- Lactating females who plan to breastfeed their infants.
- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation.
Gender:
All
Minimum age:
N/A
Maximum age:
30 Years
Healthy volunteers:
No
Start date:
December 31, 2024
Completion date:
February 13, 2031
Lead sponsor:
Agency:
Children's Oncology Group
Agency class:
Other
Source:
Children's Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06401330
