Trial Title:
Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
NCT ID:
NCT06500455
Condition:
Anatomic Stage IV Breast Cancer AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Breast Carcinoma
Metastatic Digestive System Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
Metastatic Melanoma
Metastatic Renal Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Neoplasms
Melanoma
Carcinoma, Renal Cell
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
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:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
ARM I (SRS)
Arm group label:
ARM II (FSRS)
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:
Radiation
Intervention name:
Fractionated Stereotactic Radiation Therapy
Description:
Undergo FSRS
Arm group label:
ARM II (FSRS)
Other name:
Fractionated Stereotactic Radiotherapy
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
ARM I (SRS)
Arm group label:
ARM II (FSRS)
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:
Radiation
Intervention name:
Stereotactic Radiosurgery
Description:
Undergo SRS
Arm group label:
ARM I (SRS)
Other name:
SRS
Other name:
Stereotactic External Beam Irradiation
Other name:
stereotactic external-beam radiation therapy
Other name:
Stereotactic Radiation Therapy
Other name:
Stereotactic Radiotherapy
Other name:
stereotaxic radiation therapy
Other name:
stereotaxic radiosurgery
Summary:
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery
(FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer
that has spread from where it first started to the brain. Radiation therapy uses high
energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of
radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy
that uses special equipment to position the patient and precisely give a single large
dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating
patients with cancer that has spread to the brain.
Detailed description:
PRIMARY OBJECTIVE:
I. To determine if the time to local failure is improved with FSRS compared to SRS in
patients with intact (i.e., unresected) brain metastases.
SECONDARY OBJECTIVES:
I. To compare time to intracranial progression-free survival between FSRS and SRS.
II. To compare overall survival between FSRS and SRS. III. To determine if the time to
local failure is improved with FSRS compared to SRS, as evaluated by central review of
imaging.
IV. To evaluate if there is any difference in central nervous system (CNS) failure
patterns (local versus [vs.] distant brain failure vs. both) in patients who receive FSRS
compared to patients who receive SRS.
V. To compare the rates of radiation necrosis in patients who receive FSRS vs. SRS.
VI. To compare the time to salvage whole brain radiation therapy (WBRT) between patients
who receive FSRS and those who receive SRS.
VII. To compare the rates of post-treatment adverse events associated with FSRS and SRS.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally,
patients undergo computed tomography (CT) and magnetic resonance imaging (MRI) on study.
ARM II: Patients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally,
patients undergo CT and MRI on study.
After completion of study treatment, patients are followed up every 3 months for 1 year,
every 4 months for 1 year then every 6 months for 3 years.
Criteria for eligibility:
Criteria:
Inclusion/Exclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of one of the
following solid tumor malignancies within 5 years prior to registration:
- Non-small cell lung cancer
- Melanoma
- Breast cancer
- Renal cell carcinoma
- Gastrointestinal cancer
- If the original histologic proof of malignancy is greater than 5 years, then
more recent pathologic confirmation (e.g., from a systemic site or brain
metastasis) or unequivocal imaging confirmation of extracranial metastatic
disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography
[PET]/CT, prostate-specific membrane antigen [PSMA] PET, etc.) is required
- Patients must have at least 1 and up to 8 total intact brain metastases detected on
a contrast-enhanced MRI performed ≤ 21 days prior to registration
- At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion
with a maximum diameter as measured on any orthogonal plane (axial, sagittal,
coronal) of ≥ 1.0 cm and ≤ 3.0 cm
- All brain metastases must be located outside of the brainstem and ≥ 5 mm from the
optic nerves or optic chiasm. Note: brainstem metastases per the MRI within 21 days
of registration are an exclusion criterion; however, if the MRI used for treatment
planning performed within 7 days of SRS/FSRS reveals a brainstem metastasis, the
patient remains eligible if the patient is considered an appropriate radiosurgery
candidate per the local investigator
- Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5
- No more than 2 lesions planned for resection if clinically indicated
- No known leptomeningeal disease (LMD)
- Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as
positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or
clinical evidence of leptomeningeal involvement. Patients with leptomeningeal
symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be
considered to have LMD even in the absence of positive CSF cytology. In
contrast, an asymptomatic or minimally symptomatic patient with mild or
nonspecific leptomeningeal enhancement (MRI) would not be considered to have
LMD. In that patient, CSF sampling is not required to formally exclude LMD, but
can be performed at the investigator's discretion based on level of clinical
suspicion
- Age ≥ 18 years
- Karnofsky performance status (KPS) ≥ 60
- Negative urine or serum pregnancy test (in persons of childbearing potential) within
14 days prior to registration. Childbearing potential is defined as any person who
has experienced menarche and who has not undergone surgical sterilization
(hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS,
or prophylactic cranial irradiation [PCI])
- New York Heart Association Functional Classification II or better (NYHA Functional
Classification III/IV are not eligible) (Note: Patients with known history or
current symptoms of cardiac disease, or history of treatment with cardiotoxic
agents, should have a clinical risk assessment of cardiac function using the New
York Heart Association Functional Classification)
- No active infection currently requiring intravenous (IV) antibiotic management
- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- No chronic obstructive pulmonary disease exacerbation or other acute respiratory
illness precluding study therapy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Miami Cancer Institute
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
786-596-2000
Investigator:
Last name:
Rupesh R. Kotecha
Email:
Principal Investigator
Facility:
Name:
Cancer Care Specialists of Illinois - Decatur
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Decatur Memorial Hospital
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Cancer Care Center of O'Fallon
Address:
City:
O'Fallon
Zip:
62269
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
HSHS Saint Elizabeth's Hospital
Address:
City:
O'Fallon
Zip:
62269
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
University of Maryland/Greenebaum Cancer Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mark V. Mishra
Phone:
800-888-8823
Investigator:
Last name:
Mark V. Mishra
Email:
Principal Investigator
Facility:
Name:
Central Maryland Radiation Oncology in Howard County
Address:
City:
Columbia
Zip:
21044
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mark Mishra
Facility:
Name:
UM Baltimore Washington Medical Center/Tate Cancer Center
Address:
City:
Glen Burnie
Zip:
21061
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mark V Mishra
Facility:
Name:
Renown Regional Medical Center
Address:
City:
Reno
Zip:
89502
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
John A. Ellerton
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center-Einstein Campus
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin Tang
Investigator:
Last name:
Justin Tang
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center-Weiler Hospital
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin Tang
Facility:
Name:
Montefiore Medical Center - Moses Campus
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin Tang
Facility:
Name:
Valley Medical Center
Address:
City:
Renton
Zip:
98055
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
425-228-3440
Email:
research@valleymed.org
Investigator:
Last name:
John A. Ellerton
Email:
Principal Investigator
Start date:
August 28, 2024
Completion date:
June 30, 2033
Lead sponsor:
Agency:
NRG Oncology
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
NRG Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500455
