Conditions: Brain Neoplasms
Keywords: Brain metastases Temozolomide Whole-brain radiotherapy Phase II trial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 55
Healthy volunteers: no

Brief 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

Arms:
arm 1: Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide. arm 2: Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks

Interventions: intervention 1: Temozolomide intervention 2: Whole brain irradiation
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: