Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
Purpose
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.
Conditions
- Anatomic Stage IV Breast Cancer 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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion 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, 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 and ≤ 3.0 cm in maximum dimension
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator ARM I (SRS) |
Patients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally, patients undergo CT and MRI on study. |
|
|
Experimental ARM II (FSRS) |
Patients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study. |
|
Recruiting Locations
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Tucson 5318313, Arizona 5551752 85719
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More Details
- NCT ID
- NCT06500455
- Status
- Recruiting
- Sponsor
- NRG Oncology
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.