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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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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

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Brain Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Whole brain irradiation plus Temozolomide

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.

Group Type EXPERIMENTAL

Temozolomide

Intervention Type DRUG

Whole brain irradiation

Intervention Type RADIATION

Whole brain irradiation

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

Group Type ACTIVE_COMPARATOR

Whole brain irradiation

Intervention Type RADIATION

Interventions

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Temozolomide

Intervention Type DRUG

Whole brain irradiation

Intervention Type RADIATION

Other Intervention Names

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Temodar or Temodal Whole brain radiotherapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No