Status:
COMPLETED
Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Cognitive/Functional Effects
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 kno...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy. Secondary * Compare ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2019
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00377156
Start Date
July 1 2006
End Date
December 15 2019
Last Update
September 16 2022
Active Locations (64)
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1
Arizona Oncology-Deer Valley Center
Phoenix, Arizona, United States, 85027
2
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States, 85260
3
Memorial Medical Center
Modesto, California, United States, 95355
4
Kaiser Permanente - Division of Research - Oakland
Oakland, California, United States, 94611