Adjuvant Radiation Therapy in Treating Patients With Brain Metastases
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|ClinicalTrials.gov Identifier: NCT00002899|
Recruitment Status : Terminated (Low accrual)
First Posted : January 27, 2003
Last Update Posted : July 2, 2012
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 or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Procedure: adjuvant therapy Radiation: radiation therapy Radiation: stereotactic radiosurgery||Phase 3|
- Investigate the efficacy and toxicity of adjuvant whole brain radiotherapy after prior surgical resection or radiosurgery of 1 to 3 brain metastases from solid tumor in patients with good performance status and controlled systemic cancer.
- Determine overall survival and progression-free survival of patients treated on this protocol.
- Determine time to neurologic progression in patients treated on this protocol.
- Determine quality of life of patients treated on this protocol.
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.
- Arm I: Patients undergo adjuvant whole brain radiotherapy (WBRT).
- Arm II: Patients do not receive adjuvant radiotherapy. Patients planning to undergo radiosurgery are randomized to 1 of 2 treatment arms.
- Arm III: Patients undergo radiosurgery followed by adjuvant WBRT within 4 weeks after surgery.
- Arm IV: Patients undergo radiosurgery alone. Quality of life is assessed at baseline, at 8 weeks, and then every 3 months thereafter.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Official Title:||Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases|
|Study Start Date :||November 1996|
|Primary Completion Date :||November 2007|
- Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
- Overall survival as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
- Progression-free survival as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
- Time to neurological progression as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
- Acute toxicity as measured by EORTC and RTOG scale 8 weeks after completion of study treatment, and then every 3 months until death
- Late toxicity as measured by Subjective, Objective, Management and Analytic/Late Effects on Normal Tissues (SOMA/LENT) scale 8 weeks after completion of study treatment, and then every 3 months until death
- Quality of life as measured by QLQ-C30 and BN-25 8 weeks after completion of study treatment, and then every 3 months until death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002899
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|Study Chair:||Rolf-Peter Mueller, MD||Medizinische Universitaetsklinik I at the University of Cologne|
|Study Chair:||Riccardo Soffietti, MD||Universita Degli Studi di Turin|