NCT00377156

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

Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy. Secondary * 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.

Conditions

• Breast Cancer
• Cognitive/Functional Effects
• Lung Cancer
• Metastatic Cancer
• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	radiation therapy	Patients undergo radiation therapy 5 days a week for 2.5 weeks
RADIATION	stereotactic radiosurgery

Timeline

• Start date: 2006-07-01
• Primary completion: 2014-10-01
• Completion: 2019-12-15
• First posted: 2006-09-15
• Last updated: 2022-09-16
• Results posted: 2017-08-24

Locations

64 sites across 2 countries: United States, Canada