|Phase III||Supportive care, Treatment||Active||18 and over||NCI, Other||N0574|
NCCTG-N0574, ACOSOG-N0574, CDR0000499633, NCI-2009-00653, NCT00377156
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.
Further Study Information
- Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy.
- Compare time to CNS (brain) failure in patients treated with these regimens.
- Compare quality of life, duration of functional independence, and long-term neurocognitive status of patients treated with these regimens.
- Compare post-treatment toxicity in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (18 to 59 vs 60 and over), extracranial disease (controlled for ≤ 3 months vs controlled for > 3 months), and number of brain metastases (1 vs 2 vs 3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo stereotactic radiosurgery (SRS).
- Arm II: Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.
Quality of life, functional independence, and neurocognitive status are assessed at baseline, at the beginning of each treatment, at weeks 6 and 12, and then at 6, 9, 12, 16, 24 , 36, 48, and 60 months.
PROJECTED ACCRUAL: A total of 238 patients will be accrued for this protocol.
- 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
- 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
Trial Lead Organizations/Sponsors
North Central Cancer Treatment GroupNational Cancer Institute
American College of Surgeons
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
|Paul D. Brown||Study Chair|
|Kurt A. Jaeckle||Study Chair|
|Richard L. Deming||Study Chair|
|Bruce Pollock||Study Chair|
|Kaiser Permanente Medical Center - Santa Clara Homestead Campus|
|Louis Fehrenbacher||Ph: 626-564-3455|
|University of Louisville School of Medicine|
|Shiao Y Woo||Ph: 866-530-5516|
|CCOP - Ochsner|
|Roland B Hawkins||Ph: 888-562-4763|
|Tufts Medical Center Cancer Center|
|Lynne P Taylor||Ph: 617-636-5000|
|Dixie Regional Medical Center - East Campus|
|R. Jeffrey Lee||Ph: 801-507-3950|
|Salt Lake City|
|R. Jeffrey Lee||Ph: 801-507-3950|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00377156
ClinicalTrials.gov processed this data on October 17, 2013
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