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| Descriptive Information Fields | |||||||||||||||||||||||||||||
| Brief Title † | Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases | ||||||||||||||||||||||||||||
| Official Title † | Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases | ||||||||||||||||||||||||||||
| 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 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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.
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 528 patients will be accrued for this protocol. |
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| Study Phase | Phase III | ||||||||||||||||||||||||||||
| Study Type † | Interventional | ||||||||||||||||||||||||||||
| Study Design † | Treatment, Randomized | ||||||||||||||||||||||||||||
| Primary Outcome Measure † | Survival as measured by stratified logrank test and Cox proportional hazards models at 6 months [ Designated as safety issue: No ] | ||||||||||||||||||||||||||||
| Secondary Outcome Measure † | Time to CNS failure [ Designated as safety issue: No ] Quality of life, in terms of brain subscale and physical and emotional functioning, as measured by FACT-BR questionnaire, physician-assessed neurological signs and symptoms, and treatment-related adverse events at 3 months post treatment [ Designated as safety issue: Yes ] Functional independence as measured by Barthel Activities of Daily Living Index and ECOG performance status [ Designated as safety issue: No ] Duration of functional independence [ Designated as safety issue: No ] Neurocognitive status as measured by objective assessment of changes in cognitive signs and symptoms and physician-assessed toxicities at 3 months post treatment [ Designated as safety issue: Yes ] |
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| Condition † | Brain and Central Nervous System Tumors Breast Cancer Cognitive/Functional Effects Lung Cancer Prostate Cancer |
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| Intervention † | Procedure: radiation therapy Procedure: stereotactic radiosurgery |
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| MEDLINE PMIDs | |||||||||||||||||||||||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() Featured trial article  ![]() |
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| Recruitment Information Fields | |||||||||||||||||||||||||||||
| Recruitment Status † | Recruiting | ||||||||||||||||||||||||||||
| Enrollment † | 528 | ||||||||||||||||||||||||||||
| Start Date † | July 2006 | ||||||||||||||||||||||||||||
| Completion Date | |||||||||||||||||||||||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||
| Contacts †† | |||||||||||||||||||||||||||||
| Location Countries † | United States, Canada | ||||||||||||||||||||||||||||
| Administrative Information Fields | |||||||||||||||||||||||||||||
| NCT ID † | NCT00377156 | ||||||||||||||||||||||||||||
| Organization ID | CDR0000499633 | ||||||||||||||||||||||||||||
| Secondary IDs †† | NCCTG-N0574, ACOSOG-N0574 | ||||||||||||||||||||||||||||
| Study Sponsor † | North Central Cancer Treatment Group | ||||||||||||||||||||||||||||
| Collaborators †† | National Cancer Institute (NCI) American College of Surgeons |
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| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||||||||||||||
| Verification Date | September 2008 | ||||||||||||||||||||||||||||
| First Received Date † | September 13, 2006 | ||||||||||||||||||||||||||||
| Last Updated Date | September 22, 2008 | ||||||||||||||||||||||||||||