Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Metastatic Cancer
About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring tumors metastatic to brain
Eligibility Criteria
Inclusion Criteria: Diagnosis of cerebral metastases meeting all of the following requirements: 1-3 de novo lesions Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s) Each lesion must be less than 3.0 cm by contrasted MRI of the brain Lesions must not be within 5 mm of optic chiasm or within the brainstem No primary germ cell tumor, small cell carcinoma, or lymphoma No leptomeningeal metastases Eligible for treatment with gamma knife or linear accelerator-based radiosurgery Performance status - ECOG 0-2 Performance status - Zubrod 0-2 Not pregnant Negative pregnancy test Fertile patients must use effective contraception * Male patients must continue to use contraception for 3 months after the completion of radiotherapy No pacemaker or other MRI-incompatible metal in body No known allergy to gadolinium Deemed to be at low risk for recurrence from any prior malignancies At least 7 days since prior chemotherapy Concurrent hormonal agents allowed Concurrent steroids allowed No prior cranial radiotherapy No prior resection of cerebral metastasis Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- St. Joseph's Hospital and Medical Center
- Foundation for Cancer Research and Education
- Mount Diablo Regional Cancer Center
- Sutter Cancer Center
- UCSF Comprehensive Cancer Center
- John Muir Comprehensive Cancer Center at John Muir Medical Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Yale Comprehensive Cancer Center
- Shands Cancer Center at the University of Florida Health Science Center
- University of Illinois Medical Center
- Genesis Regional Cancer Center at Genesis Medical Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Brigham and Women's Hospital
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Health System
- Siteman Cancer Center at Barnes-Jewish Hospital
- John F. Kennedy Medical Center
- SUNY Upstate Medical University Hospital
- Blumenthal Cancer Center at Carolinas Medical Center
- Carolina Neurosurgery and Spine Associates
- American College of Surgeons Oncology Group
- Duke Comprehensive Cancer Center
- Comprehensive Cancer Center at Wake Forest University
- Cleveland Clinic Taussig Cancer Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Allegheny General Hospital
- University of Pittsburgh Medical Center - Shadyside Hospital
- University of Pittsburgh Medical Center
- UPMC St. Margaret
- Methodist Cancer Center at Methodist University Hospital
- American Fork Hospital
- Cancer Center at the University of Virginia
- Massey Cancer Center at Virginia Commonwealth University
- University of Wisconsin Comprehensive Cancer Center
- Medical College of Wisconsin Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
radiosurgery
radiosurgery + WBRT
Patients undergo radiosurgery. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.
Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.