Brain Neoplasms Clinical Trial
Official title:
Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment
RATIONALE
- Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High
daily dose temozolomide combined with fractionated radiotherapy may make tumor cells
more sensible to treatment.
PURPOSE
- This randomized phase II trial, assess in patients with brain metastases from solid
tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to
improve the results obtained with WBRT.
Primary Outcome Measures
- Objective Response Rates
Secondary Outcome Measures
- Survival Free of Brain Metastases progression
- Overall Survival
- Systemic Side effects
Objectives
Primary
- Compare objective response rates in both arms of treatment
Secondary
- Compare survival free of progression in both arms of treatment
- Compare Overall Survival in both arms of treatment
- Compare side effects
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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