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

NCT ID: NCT00820963

Last Updated: 2011-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Study Groups

Arm I

Patients undergo standard radiotherapy 5 days a week for 6 weeks.

Group Type: EXPERIMENTAL

radiation therapy

Intervention Type: RADIATION

Patients undergo standard radiotherapy

Arm II

Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.

Group Type: EXPERIMENTAL

hypofractionated radiation therapy

Intervention Type: RADIATION

Patients undergo hypofractionated radiotherapy

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.

Group Type: EXPERIMENTAL

temozolomide

Intervention Type: DRUG

Given orally

Interventions

temozolomide

Given orally

Intervention Type: DRUG

hypofractionated radiation therapy

Patients undergo hypofractionated radiotherapy

Intervention Type: RADIATION

radiation therapy

Patients undergo standard radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed glioblastoma multiforme

• Grade 4 disease (WHO)

PATIENT CHARACTERISTICS:

• WHO performance status (PS) 0-2 (PS 3-4 allowed if secondary to a neurological physical handicap)
• Life expectancy ≥ 3 months
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL
• Bilirubin < 1.5 times upper limit of normal (ULN)
• Transaminases ≤ 3 times ULN
• Creatinine < 1.5 times ULN
• Able to tolerate the 3 treatment options
• No other malignancy within the past 5 years except for curatively treated basal cell or squamous cell carcinoma of the skin
• No acute or chronic severe illness that, in the investigator's opinion, contraindicates participation in the study

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy, radiotherapy, or immunotherapy
• Concurrent corticosteroids allowed provided patient is receiving the lowest dose necessary for optimal functioning

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Principal Investigators

Didier Frappaz, MD

Role:

Centre Leon Berard

Locations

Centre Leon Berard

Lyon, , France

Countries

France

Other Identifiers

LEONB-ET2005-006

Identifier Type: -

Identifier Source: secondary_id

LEONB-Nordic Glioma Adulte

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0031

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2006-003606-25

Identifier Type: -

Identifier Source: secondary_id

SPRI-LEONB-ET2005-006

Identifier Type: -

Identifier Source: secondary_id

CDR0000626713

Identifier Type: -

Identifier Source: org_study_id