Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery
Cognitive/Functional Effects, Metastatic Cancer, Neurotoxicity
About this trial
This is an interventional treatment trial for Cognitive/Functional Effects focused on measuring neurotoxicity, radiation toxicity, cognitive/functional effects, tumors metastatic to brain, unspecified adult solid tumor, protocol specific
Eligibility Criteria
Pre-registration Inclusion Criteria:
- Number of Brain Metastases - Four or fewer brain metastases (as defined on the pre-operative MRI or CT brain scan) and status post resection of one of the lesions.
- Non-CNS Primary Site - Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Note: Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site.
- Size of Metastases - Any unresected lesions must measure < 3.0 cm in maximal extent on the contrasted MRI or CT brain scan obtained ≤ 35 days prior to pre-registration. The unresected lesions will be treated with SRS as outlined in the treatment section of the protocol. Note: The metastases size restriction does not apply to the resected brain metastasis; with resected brain metastases only surgical cavity size determines eligibility.
Size of Resection Cavity - Resection cavity must measure <5.0 cm in maximal extent on the post-operative MRI or CT brain scan obtained ≤35 days prior to pre-registration.
Note: It is permissible for the resection of a dominant brain metastasis to include a smaller "satellite" metastasis as long as the single resection cavity is less than the maximum size requirements.
- Tumor Staging Procedures - All standard tumor-staging procedures necessary to define baseline extra cranial disease status completed ≤42 days prior to pre-registration.
- Treatment with Gamma Knife or Radiosurgery - Able to be treated with either a gamma knife or a linear accelerator-based radiosurgery system.
- Age ≥ 18 years
- Neurocognitive Testing - Willing and able to complete neurocognitive testing without assistance from family and companions. Note: Because neurocognitive testing is one of the primary goals of this study, patients must be able to utilize English language booklets (and/or French booklets if enrolled in Canada).
- Quality of Life (QOL) Questionnaires - Willing and able to complete QOL by themselves or with assistance
- ECOG Performance Status - ECOG Performance Status (PS) 0, 1, or 2.
- SRS Credentialed by IROC Houston Quality Assurance - The site's SRS facility is IROC Houston Quality Assurance approved.
- Neurocognitive Testing Credentialing - The site study team member performing neurocognitive testing of patients must have credentialing confirming completion of the neurocognitive testing training of the protocol.
- Written Informed Consent - Provide written informed consent
- Mandatory Samples for Correlative Tests - Willing to provide mandatory blood and urine samples for correlative research purposes.
Pre-registration Exclusion Criteria:
- Pregnancy, Nursing and Contraception - pregnant women, nursing women and men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment.
- Prior Cranial Radiation Therapy
- MRI or CT Scans - Inability to complete a MRI or CT scan with contrast of the head.
- Gadolinium Allergy - Known allergy to gadolinium.
- Cytotoxic Chemotherapy - Planned cytotoxic chemotherapy during the SRS or WBRT.
- Other Tumor Types - Primary germ cell tumor, small cell carcinoma, or lymphoma
- Leptomeningeal Metastasis - Widespread definitive leptomeningeal metastasis
- Location of Brain Metastasis - A brain metastasis that is located ≤ 5 mm of the optic chiasm or within the brainstem.
Randomization Inclusion Criteria:
Number of Unresected Lesions - Post-operative MRI or CT scan confirmed zero, one, two or three unresected lesions.
1.1 Each unresected lesion must measure ≤ 3.0 cm in maximal extent on the contrasted post-operative MRI or CT brain scan.
1.2 Note: The pre-registration, post-operative, brain scan may be used for the randomization scan if obtained ≤ 28 days prior to randomization.
1.3 Note: If there are no unresected brain metastases (i.e., all brain metastases have been resected), a post-operative CT brain scan may be used if obtained ≤ 28 days prior to randomization.
Size of Resection Cavity - Post-operative MRI or CT scan confirms resection cavity measures < 5.0 cm in maximal extent.
2.1 Note: The pre-registration, post-operative brain scan may be used for the randomization scan if obtained ≤ 28 days prior to randomization.
2.2 Note: If there are no unresected brain metastases (i.e., all brain metastases have been resected), a post-operative CT brain scan may be used if obtained ≤28 days prior to randomization.
- Urine or Serum Pregnancy Test - Negative urine or serum pregnancy test done ≤ 7 days prior to randomization, for women of child bearing potential only.
Randomization Exclusion Criteria: none
Sites / Locations
- Mills - Peninsula Hospitals
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Christiana Care Health System-Christiana Hospital
- Mount Sinai Medical Center
- John B Amos Cancer Center
- NorthShore University HealthSystem-Evanston Hospital
- Memorial Hospital of South Bend
- Lowell General Hospital
- Saint Vincent Hospital/Reliant Medical Group
- West Michigan Cancer Center
- Sanford Clinic North-Bemidji
- Mayo Clinic Cancer Center
- Regions Hospital
- United Hospital
- University of Nebraska Medical Center
- Wentworth-Douglass Hospital
- Somerset Medical Center
- State University of New York Upstate Medical University
- University of North Carolina at Chapel Hill
- Novant Health Presbyterian Medical Center
- Sanford Bismarck Medical Center
- Sanford Clinic North-Fargo
- Sanford Roger Maris Cancer Center
- Summa Akron City Hospital/Cooper Cancer Center
- Case Western Reserve University
- Legacy Good Samaritan Hospital and Medical Center
- Abington Memorial Hospital
- Saint Luke's University Hospital-Bethlehem Campus
- Geisinger Medical Center
- Aria Health-Torresdale Campus
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- Thompson Cancer Survival Center
- University of Texas Medical Branch
- Saint Vincent Hospital
- Froedtert and the Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I - WBRT
Arm II - SRS
Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.
Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Patient observation/follow up occurs at week 12 and months 6, 9, 12, 16 and 24 post registration/randomization. Event monitoring occurs every 6 months until 5 years post registration/randomization.