Surgery and Whole Brain Radiotherapy (RT) Versus Whole Brain Radiotherapy (RT) and Radiosurgery for 1-3 Resectable Brain Metastases
Recruitment status was Active, not recruiting
Patients in good general condition with resectable brain metastases, looks better with more intense treatment of metastases. This local treatment has been accomplished with surgery or radiosurgery. However, there are no randomized studies comparing these two types of treatment. The purpose of this study is to make this.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Surgery and Whole Brain Radiotherapy Versus Whole Brain Radiotherapy and Radiosurgery for 1-3 Resectable Brain Metastases: Phase III Prospective Pilot Study|
- feasibility [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]One year after the start of patient recruitment, the study will be analyzed for feasibility and, if feasible, we will pursue the study with primary end-point of comparing the toxicity of exclusive radiation therapy arm with the surgical arm.
- complications and toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]One year after the start of patient recruitment, the study will be analyzed for toxicity of the radiotherapy arm versus the arm surgical complications, and if compatible, will continue the study until 70 patients in each arm.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: surgery+whole-brain irradiation
brain metastases is resected and the patient is submitted to whole-brain irradiation
resection of brain metastases
Other Name: neurosurgery
Active Comparator: whole-brain irradiation+radiosurgery
patients will be submitted to whole-brain irradiation and after, they will be submitted to radiosurgery.
radiosurgery to brain metastases
Other Name: stereotactic radiosurgery
Patients in good general condition with resectable 1-3 brain metastases will be randomized to surgery and whole brain radiotherapy and whole brain radiotherapy and radiosurgery. Initially we will evaluate the feasibility of carrying out the study with 15 patients in each arm, and after, we will follow with the primary end-point of comparing the toxicity of the exclusively radiotherapy arm with complications of the surgical arm. As a secondary end-point, we will evaluate local recurrence-free survival, overall survival, distance cerebral relapse-free survival (metachronous brain metastasis), free of neurological progression survival, free of neurological death survival, free of dependent life (another person)survival , steroid-free survival and quality of life.