Surgery and Whole Brain Radiotherapy (RT) Versus Whole Brain Radiotherapy (RT) and Radiosurgery for 1-3 Resectable Brain Metastases
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|ClinicalTrials.gov Identifier: NCT01169129|
Recruitment Status : Withdrawn (No participants enrolled.)
First Posted : July 26, 2010
Last Update Posted : February 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metastases Cancer||Other: surgery Radiation: radiosurgery||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Surgery and Whole Brain Radiotherapy Versus Whole Brain Radiotherapy and Radiosurgery for 1-3 Resectable Brain Metastases: Phase III Prospective Pilot Study|
|Study Start Date :||July 2010|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
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
- feasibility [ Time Frame: 1 year ]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 ]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.
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): NCT01169129
|Barretos Cancer Hospital|
|Barretos, São Paulo, Brazil, 14784400|
|Principal Investigator:||Ricardo A Nakamura, MD||Barretos Cancer Hospital|