NCT01015534

Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment

Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Instituto Nacional de Cancerologia de Mexico · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Brain Neoplasms

Interventions

Type	Name	Description
DRUG	Temozolomide
RADIATION	Whole brain irradiation

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-11-18
• Last updated: 2013-05-08
• Results posted: 2013-05-08

Locations

1 site across 1 country: Mexico