Trial Title:
Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
NCT ID:
NCT05863195
Condition:
Metastatic Colorectal Carcinoma
Metastatic Malignant Neoplasm in the Liver
Stage IV Colorectal Cancer AJCC v8
Unresectable Colorectal Carcinoma
Conditions: Official terms:
Carcinoma
Colorectal Neoplasms
Neoplasms
Leucovorin
Bevacizumab
Antineoplastic Agents, Immunological
Cetuximab
Panitumumab
Oxaliplatin
Fluorouracil
Irinotecan
Floxuridine
Endothelial Growth Factors
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunoglobulin G
Deoxyuridine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Bevacizumab
Description:
Given IV
Arm group label:
Arm B (standard chemotherapy)
Other name:
ABP 215
Other name:
Anti-VEGF
Other name:
Anti-VEGF Humanized Monoclonal Antibody
Other name:
Anti-VEGF Monoclonal Antibody SIBP04
Other name:
Anti-VEGF rhuMAb
Other name:
Avastin
Other name:
Bevacizumab awwb
Other name:
Bevacizumab Biosimilar ABP 215
Other name:
Bevacizumab Biosimilar BEVZ92
Other name:
Bevacizumab Biosimilar BI 695502
Other name:
Bevacizumab Biosimilar CBT 124
Other name:
Bevacizumab Biosimilar CT-P16
Other name:
Bevacizumab Biosimilar FKB238
Other name:
Bevacizumab Biosimilar GB-222
Other name:
Bevacizumab Biosimilar HD204
Other name:
Bevacizumab Biosimilar HLX04
Other name:
Bevacizumab Biosimilar IBI305
Other name:
Bevacizumab Biosimilar LY01008
Other name:
Bevacizumab Biosimilar MIL60
Other name:
Bevacizumab Biosimilar Mvasi
Other name:
Bevacizumab Biosimilar MYL-1402O
Other name:
Bevacizumab Biosimilar QL 1101
Other name:
Bevacizumab Biosimilar QL1101
Other name:
Bevacizumab Biosimilar RPH-001
Other name:
Bevacizumab Biosimilar SCT501
Other name:
Bevacizumab Biosimilar Zirabev
Other name:
Bevacizumab-awwb
Other name:
Bevacizumab-bvzr
Other name:
BP102
Other name:
BP102 Biosimilar
Other name:
HD204
Other name:
Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
Other name:
Mvasi
Other name:
MYL-1402O
Other name:
QL1101
Other name:
Recombinant Humanized Anti-VEGF Monoclonal Antibody
Other name:
rhuMab-VEGF
Other name:
SCT501
Other name:
SIBP 04
Other name:
SIBP-04
Other name:
SIBP04
Other name:
Zirabev
Intervention type:
Biological
Intervention name:
Cetuximab
Description:
Given IV
Arm group label:
Arm A (HAI, floxuridine, standard chemotherapy)
Arm group label:
Arm B (standard chemotherapy)
Other name:
Cetuximab Biosimilar CDP-1
Other name:
Cetuximab Biosimilar CMAB009
Other name:
Cetuximab Biosimilar KL 140
Other name:
Chimeric Anti-EGFR Monoclonal Antibody
Other name:
Chimeric MoAb C225
Other name:
Chimeric Monoclonal Antibody C225
Other name:
Erbitux
Other name:
IMC-C225
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo SPECT/CT and/or CT
Arm group label:
Arm A (HAI, floxuridine, standard chemotherapy)
Arm group label:
Arm B (standard chemotherapy)
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:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Floxuridine
Description:
Given via HAI pump
Arm group label:
Arm A (HAI, floxuridine, standard chemotherapy)
Other name:
2'-Deoxy-5-fluorouridine
Other name:
5-Fluoro-2'-deoxyuridine
Other name:
5-Fluorodeoxyuridine
Other name:
5-Fluorouracil deoxyriboside
Other name:
5-FUdR
Other name:
FDUR
Other name:
Floxuridin
Other name:
Fluorodeoxyuridine
Other name:
Fluorouridine Deoxyribose
Other name:
Fluoruridine Deoxyribose
Other name:
FUdR
Other name:
WR-138720
Intervention type:
Drug
Intervention name:
Fluorouracil
Description:
Given IV
Arm group label:
Arm A (HAI, floxuridine, standard chemotherapy)
Arm group label:
Arm B (standard chemotherapy)
Other name:
5 Fluorouracil
Other name:
5 Fluorouracilum
Other name:
5 FU
Other name:
5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Other name:
5-Fluorouracil
Other name:
5-Fluracil
Other name:
5-Fu
Other name:
5FU
Other name:
AccuSite
Other name:
Carac
Other name:
Fluoro Uracil
Other name:
Fluouracil
Other name:
Flurablastin
Other name:
Fluracedyl
Other name:
Fluracil
Other name:
Fluril
Other name:
Fluroblastin
Other name:
Ribofluor
Other name:
Ro 2-9757
Other name:
Ro-2-9757
Intervention type:
Procedure
Intervention name:
Implantation
Description:
Undergo surgery to place the HAI pump
Arm group label:
Arm A (HAI, floxuridine, standard chemotherapy)
Intervention type:
Procedure
Intervention name:
Intrahepatic Infusion Procedure
Description:
Undergo HAI
Arm group label:
Arm A (HAI, floxuridine, standard chemotherapy)
Other name:
HAI
Other name:
Hepatic Arterial Infusion
Other name:
Hepatic Artery Infusion
Other name:
IHI
Other name:
Intrahepatic Infusion
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Given IV
Arm group label:
Arm A (HAI, floxuridine, standard chemotherapy)
Arm group label:
Arm B (standard chemotherapy)
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
Given IV
Arm group label:
Arm A (HAI, floxuridine, standard chemotherapy)
Arm group label:
Arm B (standard chemotherapy)
Other name:
Folinic acid
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Given IV
Arm group label:
Arm A (HAI, floxuridine, standard chemotherapy)
Arm group label:
Arm B (standard chemotherapy)
Other name:
1-OHP
Other name:
Ai Heng
Other name:
Aiheng
Other name:
Dacotin
Other name:
Dacplat
Other name:
Diaminocyclohexane Oxalatoplatinum
Other name:
Eloxatin
Other name:
Eloxatine
Other name:
JM-83
Other name:
Oxalatoplatin
Other name:
Oxalatoplatinum
Other name:
RP 54780
Other name:
RP-54780
Other name:
SR-96669
Intervention type:
Biological
Intervention name:
Panitumumab
Description:
Given IV
Arm group label:
Arm A (HAI, floxuridine, standard chemotherapy)
Arm group label:
Arm B (standard chemotherapy)
Other name:
ABX-EGF
Other name:
ABX-EGF Monoclonal Antibody
Other name:
ABX-EGF, Clone E7.6.3
Other name:
E7.6.3
Other name:
Human IgG2K Monoclonal Antibody
Other name:
MoAb ABX-EGF
Other name:
MoAb E7.6.3
Other name:
Monoclonal Antibody ABX-EGF
Other name:
Monoclonal Antibody E7.6.3
Other name:
Vectibix
Intervention type:
Procedure
Intervention name:
Single Photon Emission Computed Tomography
Description:
Undergo SPECT/CT
Arm group label:
Arm A (HAI, floxuridine, standard chemotherapy)
Other name:
Medical Imaging, Single Photon Emission Computed Tomography
Other name:
Single Photon Emission Tomography
Other name:
Single-Photon Emission Computed
Other name:
single-photon emission computed tomography
Other name:
SPECT
Other name:
SPECT imaging
Other name:
SPECT SCAN
Other name:
SPET
Other name:
ST
Other name:
tomography, emission computed, single photon
Other name:
Tomography, Emission-Computed, Single-Photon
Summary:
This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in
addition to standard of care chemotherapy versus standard of care chemotherapy alone in
treating patients with colorectal cancer that has spread to the liver (liver metastases)
and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a
tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is
already approved by the Food and Drug Administration (FDA) for use in metastatic
colorectal cancer to the liver, but it is only available at a small number of hospitals,
and most of the time it is not used until standard chemotherapy stops working. Standard
chemotherapy drugs work in different ways to stop the growth of tumor cells, either by
killing the cells, by stopping them from dividing, or by stopping them from spreading.
Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing
unresectable colorectal liver metastases.
Detailed description:
PRIMARY OBJECTIVE:
I. To determine if patients with persistently unresectable colorectal liver metastases
(CRLM) after treatment with first-line chemotherapy have improved overall survival (OS)
with hepatic arterial infusion (HAI) and systemic chemotherapy versus systemic
chemotherapy alone.
SECONDARY OBJECTIVES:
I. To determine whether there is a direct association between hepatic progression free
survival (hPFS) and overall survival (OS) when patients are treated with HAI combined
with systemic chemotherapy for unresectable CRLM.
II To determine the impact on progression free survival (overall, hepatic and
extrahepatic) for patients with unresectable CRLM treated with HAI in combination with
systemic chemotherapy.
III. To determine objective response rate (ORR) in the liver, defined as the proportion
of patients achieving complete or partial response by Response Evaluation Criteria is
Solid Tumors (RECIST) 1.1.
IV. To determine the rate of conversion to resectable disease, defined as the proportion
of patients who successfully convert from unresectable to resectable status and undergo
R0/R1 resection/ablation.
V. To determine the rate in which patients are intended to be treated with HAI but are
deemed ineligible at the time of planned pump insertion due to detection of occult
extrahepatic disease or unsuitable arterial anatomy (Intra-Operative Ineligibility, IOI).
VI. To determine the extent to which patient and disease-specific factors correlate with
short- and long-term risk of HAI-specific complications.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo surgery to place the HAI pump, followed by single photon emission
computed tomography/computed tomography (SPECT/CT) on study. Patients then receive
floxuridine via the HAI pump on study. Patients also receive one of the following
standard chemotherapy regimens per the treating physician: FOLFOX (fluorouracil
intravenously [IV], oxaliplatin IV, and leucovorin IV), FOLFIRI (fluorouracil IV,
irinotecan IV, and leucovorin IV), or OX/IRI (oxaliplatin IV and irinotecan IV) with or
without cetuximab IV and/or panitumumab IV on study. Patients also undergo CT scans
throughout the trial.
ARM B: Patients receive one of the following standard chemotherapy regimens per the
treating physician: FOLFOXIRI (fluorouracil IV, oxaliplatin IV, irinotecan IV, and
leucovorin IV), FOLFOX, FOLFIRI, or OX/IRI with or without cetuximab IV, panitumumab IV,
and/or bevacizumab IV on study. Patients also undergo CT scans throughout the trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient must be >= 18 years of age
- Patient must have confirmed unresectable liver confined metastatic colorectal cancer
(CRC).
- Patient must not have radiographically or clinically evident extrahepatic
disease (including but not limited to radiographically positive periportal
lymph nodes).
- NOTE: Patients found to have positive periportal nodes at the time of HAI
placement can remain on study.
- Patient may have calcified pulmonary nodules, and/or =< 5 indeterminate and
stable (for a minimum of 3 months on chemotherapy) pulmonary nodules each
measuring =< 6 mm in maximal axial dimension.
- Patient's primary tumor may be in place.
- Patient must have received 3-6 months of previous first-line chemotherapy that meet
one of the following three criteria: a) have received at least 6 but no more than 12
cycles of first-line cytotoxic chemotherapy (where 1 cycle = 14 days) OR b) have
received at least 4 but no more than 8 cycles of first-line cytotoxic chemotherapy
(where 1 cycle = 21 days) OR c) have developed new colorectal liver metastases
(CRLM) within 12 months of completing adjuvant systemic therapy for stage II-III
colorectal cancer.
- NOTE: First-line chemotherapy may have included any of the following regimens
as listed in the National Comprehensive Cancer Network (NCCN) Guidelines:
leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX) (or
equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil, and
irinotecan (FOLFIRI) (or equivalent), leucovorin calcium (calcium folinate),
5-fluorouracil, oxaliplatin, and irinotecan (FOLFOXIRI), each with or without
any of the following: bevacizumab, cetuximab, or panitumumab.
- Patient must have stable or responding disease on first-line chemotherapy by RECIST
1.1 criteria
- Patient must meet the following criteria for technical unresectability:
- A margin-negative resection requires resection of three hepatic veins, both
portal veins, or the retrohepatic vena cava OR a resection that leaves less
than two adequately perfused and drained segments.
- NOTE: Institutional multidisciplinary review is required to confirm
unresectability and rule out radiographically positive extrahepatic disease.
- Patient must undergo CT angiography (chest/abdomen/pelvis) to confirm acceptable
hepatic arterial anatomy for HAI and to rule out extrahepatic disease within 4 weeks
prior to randomization.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status
0-1 and be clinically fit to undergo surgery as determined by the pre-operative
evaluation.
- Leukocytes >= 3,000/mcL (obtained =< 14 days prior to protocol randomization)
- Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 14 days prior to protocol
randomization)
- Platelets >= 100,000/mcL (obtained =< 14 days prior to protocol randomization)
- Total Bilirubin =< 1.5 mg/dL (obtained =< 14 days prior to protocol randomization)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT])
=< 3.0 x institutional upper limit of normal (ULN) (obtained =< 14 days prior to
protocol randomization)
- Creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 50 mL/min
calculated by the Cockcroft-Gault method (obtained =< 14 days prior to protocol
randomization)
- Calcium >= institutional lower limit of normal (LLN)
- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months of randomization are eligible
for this trial. Testing for HIV is not required for entry onto the study
Exclusion Criteria:
- Patient must not have a liver tumor burden exceeding 70% of total liver volume.
- Patient must not have had prior radiation to the liver (prior radiation therapy to
the pelvis is acceptable if completed at least 2 weeks prior to randomization).
- Patient must not have had prior trans-arterial bland embolization, chemoembolization
(TACE) or radioembolization (TARE).
- Patient must not have had prior treatment with HAI/floxuridine (FUDR)
- Patient must not have microsatellite instability-high (MSI-H) colorectal cancer.
- Patient must not have CRLM that could be resected with 2-stage hepatectomy,
including associating liver partition and portal vein ligation (ALPPS).
- Patient must not have an active infection, serious or non-healing active wound,
ulcer, or bone fracture.
- Patient must not have any serious medical problems which would preclude receiving
the protocol treatment or would interfere with the cooperation with the requirements
of this trial.
- Patient must not have cirrhosis and/or clinical or radiographic evidence of portal
hypertension
- Patient must not be pregnant or breast-feeding due to the potential harm to an
unborn fetus and possible risk for adverse events in nursing infants with the
treatment regimens being used.
- All patients of childbearing potential must have a blood test or urine study
within 14 days prior to randomization to rule out pregnancy.
- A patient of childbearing potential is defined as anyone, regardless of sexual
orientation or whether they have undergone tubal ligation, who meets the
following criteria: 1) has achieved menarche at some point, 2) has not
undergone a hysterectomy or bilateral oophorectomy; or 3) has not been
naturally postmenopausal (amenorrhea following cancer therapy does not rule out
childbearing potential) for at least 24 consecutive months (i.e., has had
menses at any time in the preceding 24 consecutive months).
- Patient must not expect to conceive or father children by using accepted and
effective method(s) of contraception or by abstaining from sexual intercourse for
the duration of their participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham Cancer Center
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
205-934-0220
Email:
tmyrick@uab.edu
Investigator:
Last name:
Midhun Malla
Email:
Principal Investigator
Facility:
Name:
UCHealth University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
720-848-0650
Investigator:
Last name:
Alexis D. Leal
Email:
Principal Investigator
Facility:
Name:
UM Sylvester Comprehensive Cancer Center at Aventura
Address:
City:
Aventura
Zip:
33180
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
954-461-2180
Investigator:
Last name:
Jashodeep Datta
Email:
Principal Investigator
Facility:
Name:
UM Sylvester Comprehensive Cancer Center at Coral Gables
Address:
City:
Coral Gables
Zip:
33146
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
305-243-2647
Investigator:
Last name:
Jashodeep Datta
Email:
Principal Investigator
Facility:
Name:
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Address:
City:
Deerfield Beach
Zip:
33442
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
305-243-2647
Investigator:
Last name:
Jashodeep Datta
Email:
Principal Investigator
Facility:
Name:
UM Sylvester Comprehensive Cancer Center at Hollywood
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
305-243-2647
Investigator:
Last name:
Jashodeep Datta
Email:
Principal Investigator
Facility:
Name:
University of Miami Miller School of Medicine-Sylvester Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
305-243-2647
Investigator:
Last name:
Jashodeep Datta
Email:
Principal Investigator
Facility:
Name:
UM Sylvester Comprehensive Cancer Center at Kendall
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
305-243-2647
Investigator:
Last name:
Jashodeep Datta
Email:
Principal Investigator
Facility:
Name:
UM Sylvester Comprehensive Cancer Center at Plantation
Address:
City:
Plantation
Zip:
33324
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
305-243-2647
Investigator:
Last name:
Jashodeep Datta
Email:
Principal Investigator
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
404-778-1868
Investigator:
Last name:
Olumide B. Gbolahan
Email:
Principal Investigator
Facility:
Name:
University of Chicago Comprehensive Cancer Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
773-702-8222
Email:
cancerclinicaltrials@bsd.uchicago.edu
Investigator:
Last name:
Ryan Merkow
Email:
Principal Investigator
Facility:
Name:
Memorial Hospital East
Address:
City:
Shiloh
Zip:
62269
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
314-747-9912
Email:
dschwab@wustl.edu
Investigator:
Last name:
Patrick Grierson
Email:
Principal Investigator
Facility:
Name:
IU Health North Hospital
Address:
City:
Carmel
Zip:
46032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
317-278-5632
Email:
iutrials@iu.edu
Investigator:
Last name:
Anita Turk
Email:
Principal Investigator
Facility:
Name:
Indiana University/Melvin and Bren Simon Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
317-278-5632
Email:
iutrials@iu.edu
Investigator:
Last name:
Anita Turk
Email:
Principal Investigator
Facility:
Name:
University of Kentucky/Markey Cancer Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
859-257-3379
Investigator:
Last name:
Michael J. Cavnar
Email:
Principal Investigator
Facility:
Name:
University of Michigan Comprehensive Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-865-1125
Investigator:
Last name:
Benjamin D. Ferguson
Email:
Principal Investigator
Facility:
Name:
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
855-776-0015
Investigator:
Last name:
Cornelius A. Thiels
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at West County Hospital
Address:
City:
Creve Coeur
Zip:
63141
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Patrick Grierson
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Patrick Grierson
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center-South County
Address:
City:
Saint Louis
Zip:
63129
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Patrick Grierson
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at Christian Hospital
Address:
City:
Saint Louis
Zip:
63136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Patrick Grierson
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at Saint Peters Hospital
Address:
City:
Saint Peters
Zip:
63376
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Patrick Grierson
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Basking Ridge
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Andrea Cercek
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Andrea Cercek
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Bergen
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Andrea Cercek
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Commack
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Andrea Cercek
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Andrea Cercek
Email:
Principal Investigator
Facility:
Name:
Mount Sinai Hospital
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-824-7309
Email:
CCTO@mssm.edu
Investigator:
Last name:
Noah A. Cohen
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Andrea Cercek
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Nassau
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Andrea Cercek
Email:
Principal Investigator
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-275-3853
Investigator:
Last name:
Hope E. Uronis
Email:
Principal Investigator
Facility:
Name:
Case Western Reserve University
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
215-728-4790
Investigator:
Last name:
Vanessa Wookey
Email:
Principal Investigator
Facility:
Name:
Allegheny General Hospital
Address:
City:
Pittsburgh
Zip:
15212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-284-2000
Investigator:
Last name:
Patrick L. Wagner
Email:
Principal Investigator
Facility:
Name:
West Penn Hospital
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
412-578-5000
Investigator:
Last name:
Patrick L. Wagner
Email:
Principal Investigator
Facility:
Name:
Vanderbilt University/Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-811-8480
Investigator:
Last name:
Chandrasekhar Padmanabhan
Email:
Principal Investigator
Facility:
Name:
Parkland Memorial Hospital
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-590-5582
Email:
canceranswerline@UTSouthwestern.edu
Investigator:
Last name:
Cecilia G. Ethun
Email:
Principal Investigator
Facility:
Name:
UT Southwestern/Simmons Cancer Center-Dallas
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-648-7097
Email:
canceranswerline@UTSouthwestern.edu
Investigator:
Last name:
Cecilia G. Ethun
Email:
Principal Investigator
Start date:
October 19, 2023
Completion date:
June 30, 2034
Lead sponsor:
Agency:
ECOG-ACRIN Cancer Research Group
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Eastern Cooperative Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05863195
