Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Completed · Phase 3

Conditions studied: Metastatic Cancer

In brief

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.

Key facts

Study ID

NCT00030628

Run by

Alliance for Clinical Trials in Oncology

People needed

480

Starts

2001-12-01

Expected to finish

2014-10-01

Last updated by the study team

2016-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Foundation for Cancer Research and Education — Phoenix, Arizona, United States
• Mount Diablo Regional Cancer Center — Concord, California, United States
• Sutter Cancer Center — Sacramento, California, United States
• UCSF Comprehensive Cancer Center — San Francisco, California, United States
• John Muir Comprehensive Cancer Center at John Muir Medical Center — Walnut Creek, California, United States
• University of Colorado Cancer Center at University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Yale Comprehensive Cancer Center — New Haven, Connecticut, United States
• Shands Cancer Center at the University of Florida Health Science Center — Gainesville, Florida, United States
• University of Illinois Medical Center — Chicago, Illinois, United States
• Genesis Regional Cancer Center at Genesis Medical Center — Davenport, Iowa, United States
• Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center — Kansas City, Kansas, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Josephine Ford Cancer Center at Henry Ford Health System — Detroit, Michigan, United States
• Siteman Cancer Center at Barnes-Jewish Hospital — St Louis, Missouri, United States
• John F. Kennedy Medical Center — Edison, New Jersey, United States
• SUNY Upstate Medical University Hospital — Syracuse, New York, United States
• Blumenthal Cancer Center at Carolinas Medical Center — Charlotte, North Carolina, United States
• Carolina Neurosurgery and Spine Associates — Charlotte, North Carolina, United States
• American College of Surgeons Oncology Group — Durham, North Carolina, United States
• Duke Comprehensive Cancer Center — Durham, North Carolina, United States
• Comprehensive Cancer Center at Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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