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

Instituto Nacional de Cancerologia de Mexico

Status and phase: Completed; Phase 2

Conditions: Brain Neoplasms

Treatments: Radiation: Whole brain irradiation; Drug: Temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT01015534

006/004/TEI

Details and patient eligibility

About

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.

Full 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

Enrollment: 55 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Whole brain irradiation plus Temozolomide

Experimental group

Description:

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.

Treatment:

Drug: Temozolomide

Radiation: Whole brain irradiation

Whole brain irradiation

Active Comparator group

Description:

Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks

Treatment:

Radiation: Whole brain irradiation