Metastatic Cancer
Conditions
Keywords
tumors metastatic to brain
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.
Detailed description
OBJECTIVES: * Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy. * Compare the time to CNS failure (brain) in patients treated with these regimens. * Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens. * Compare the post-treatment toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radiosurgery. * Arm II: 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. PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 5 years.
Interventions
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to CNS failure | Up to 4 years |
| Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire | From baseline to up to 3 months |
| Change in the duration of functional independence using the Barthel ADL Index score | From baseline to up to 4 years |
Countries
United States
Outcome results
None listed