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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico
• Treatments: Dacarbazine; Temozolomide

Criteria

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