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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002899 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Adjuvant radiation therapy may kill any remaining tumor cells following surgery or radiosurgery for brain metastases.
PURPOSE: This randomized phase III trial is studying surgery or radiosurgery alone to see how well it works compared to surgery or radiosurgery and whole-brain radiation therapy in treating brain metastases in patients with solid tumors.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Procedure: adjuvant therapy Radiation: radiation therapy Radiation: stereotactic radiosurgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases |
Estimated Enrollment: | 340 |
Study Start Date: | November 1996 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center, number of brain metastases (single vs multiple), type of primary tumor (stable systemic cancer vs synchronous or unknown primary), WHO performance status (0-1 vs 2), and treatment (prior surgical resection vs planned radiosurgery).
Patients who have undergone complete surgical resection are randomized to 1 of 2 treatment arms within 4 weeks after surgery.
After completion if study treatment, patients are followed at 8 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 340 patients (85 per treatment arm) will be accrued for this study within 3.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of brain metastases from a histologically confirmed primary or metastatic extracranial tumor, meeting 1 of the following criteria:
Asymptomatic synchronous primary tumor (treatable by surgery, radiotherapy, chemotherapy, or hormonal therapy)
Must have one to three brain lesions, confirmed by enhanced MRI prior to radiosurgery or surgery
Patients planning to undergo radiosurgery must meet the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Investigator: | Rolf-Peter Mueller, MD | Medizinische Universitaetsklinik I at the University of Cologne |
Investigator: | Riccardo Soffietti, MD | Universita Degli Studi di Turin |
Study ID Numbers: | CDR0000065229, EORTC-22952, EORTC-26001 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002899 History of Changes |
Health Authority: | United States: Federal Government |
adult tumors metastatic to brain |
Immunologic Factors Adjuvants, Immunologic Neoplasm Metastasis Central Nervous System Neoplasms Nervous System Neoplasms |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Immunologic Factors Physiological Effects of Drugs |
Nervous System Diseases Adjuvants, Immunologic Neoplasm Metastasis Central Nervous System Neoplasms Pharmacologic Actions Nervous System Neoplasms |