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

Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma

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.

Study Overview

• Status: Completed
• Conditions: Brain and Central Nervous System Tumors
• Intervention / Treatment: Drug: temozolomide; Radiation: radiation therapy; Radiation: hypofractionated radiation therapy

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69373
    • Centre Leon Berard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Patients undergo standard radiotherapy 5 days a week for 6 weeks.	Radiation: radiation therapy; Patients undergo standard radiotherapy
Experimental: Arm II; Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.	Radiation: hypofractionated radiation therapy; Patients undergo hypofractionated radiotherapy
Experimental: 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.	Drug: temozolomide; Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Duration of survival

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Didier Frappaz, MD, Centre Leon Berard

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 9, 2009
• First Submitted That Met QC Criteria: January 9, 2009
• First Posted (Estimate): January 12, 2009

Study Record Updates

• Last Update Posted (Estimate): May 12, 2011
• Last Update Submitted That Met QC Criteria: May 11, 2011
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: CDR0000626713; LEONB-ET2005-006; LEONB-Nordic Glioma Adulte; INCA-RECF0031; EUDRACT-2006-003606-25; SPRI-LEONB-ET2005-006