Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases. PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.
Checked against the public recordLast updated Sep 16, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Radiation: radiation therapy; Radiation: stereotactic radiosurgery
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
DISEASE CHARACTERISTICS: * Diagnosis of cerebral metastases meeting the following criteria: * One to three presumed brain metastases * Metastases must be from a histologically confirmed extracerebral site (e.g., lung, breast, prostate) * Histologic confirmation may have been from the primary tumor site, from another metastatic site (e.g., osseous metastasis, adrenal metastasis), or from the metastatic brain lesion(s) * Each lesion must measure less than 3.0 cm by contrast MRI of the brain performed within the past 21 days * Lesions must not be within 5 mm of the optic chiasm or within the brainstem * Eligibility for treatment with gamma knife or linear accelerator-based radiosurgery confirmed by a radiation oncologist * No primary germ cell tumor, small cell carcinoma, or lymphoma * No leptomeningeal metastases * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Male or female * Menopausal status not specified * ECOG performance status 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 the body * No known allergy to gadolinium PRIOR CONCURRENT THERAPY: * More than 7 days since prior and no concurrent chemotherapy * No prior cranial radiotherapy * No prior resection of cerebral metastases * Concurrent hormonal agents, steroids, and/or anticonvulsants allowed
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Arizona Oncology-Deer Valley CenterPhoenix, Arizona
- Arizona Oncology Services FoundationScottsdale, Arizona
- Memorial Medical CenterModesto, California
- Kaiser Permanente - Division of Research - OaklandOakland, California
- St. Joseph Hospital Regional Cancer Center - OrangeOrange, California
- Rohnert Park Cancer CenterRohnert Park, California
- Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California
- Kaiser Permanente Medical Center - Santa RosaSanta Rosa, California
- University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado
- Veterans Affairs Medical Center - DenverDenver, Colorado
- Mayo Clinic - JacksonvilleJacksonville, Florida
- Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 16, 2022. Always confirm current availability with the study team.