Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment
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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rates. Assessed With Cranial MRI
Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI. Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants.
90 days
No
Carlos Gamboa-Vignolle, MD
Principal Investigator
Instituto Nacional de Cancerología de México
Mexico: Federal Commission for Protection Against Health Risks
006/004/TEI
NCT01015534
January 2006
October 2009
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