Standard Radiation Therapy, Higher-Dose Radiation Therapy, or Chemotherapy in Treating Older Patients With Glioblastoma Multiforme

Phase 3

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Radiation: radiation therapy; Radiation: hypofractionated radiation therapy; Drug: temozolomide

• Registration Number: NCT00820963
• Lead Sponsor: Centre Leon Berard

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether standard radiation therapy, higher-dose radiation therapy, or chemotherapy is more effective in treating older patients with glioblastoma multiforme.

PURPOSE: This randomized phase III trial is studying standard radiation therapy to see how well it works compared with higher-dose radiation therapy or chemotherapy in treating older patients with glioblastoma multiforme.

Detailed Description

OBJECTIVES:

Primary

* Compare the survival of patients over 60 with glioblastoma multiforme treated with standard radiotherapy vs hypofractionated radiotherapy vs chemotherapy.

Secondary

* Compare the quality of life (QLQ-C30) of these patients.

* Compare the safety, tolerance, and toxicity of these regimens.

* Assess the pharmacoeconomic cost of these regimens.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients undergo standard radiotherapy 5 days a week for 6 weeks.

* Arm II: Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.

* Arm III: Patients receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Status Verified: 2009-07
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-11
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I	radiation therapy	Patients undergo standard radiotherapy 5 days a week for 6 weeks.
Arm II	hypofractionated radiation therapy	Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.
Arm III	temozolomide	Patients receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Duration of survival

Trial Locations

Locations (1)

Centre Leon Berard; 🇫🇷 Lyon, France