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

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

Inclusion Criteria:

• Karnofsky performance status (KPS) ≥ 50
• Life expectancy ≥ 12 weeks
• Histologically confirmed non lymphomatous solid tumors at primary site
• Brain metastases diagnosed with cranial MRI/CT.
• Extracranial metastases or primary tumor uncontrolled are allowed
• Hemoglobin ≥ 10 g/dl
• Absolute neutrophil count of > 1500/mm3
• Platelet count of ≥ 100,000/mm3
• Blood urea nitrogen (BUN) ≤ 25 mg/dl,
• Serum creatinin ≤ 1.5 mg/dl
• Serum bilirubins ≤ 1.5 mg/dl,
• Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ twice the upper normal limit

Exclusion Criteria

• Pregnant or breast feeding woman
• History of allergic reaction to iodinated contrast media
• Inability to swallow
• Systemic chemotherapy in previous 3 weeks
• Oral chemotherapy in previous 2 weeks
• Prior surgery, chemotherapy, or radiotherapy for a brain neoplasm
• Meningeal carcinomatosis