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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00820963

Enrollment

Registered

2009-01-12

Start date

2006-07-31

Completion date

Unknown

Last updated

2011-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma

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.

Interventions

DRUGtemozolomide

Given orally

RADIATIONhypofractionated radiation therapy

Patients undergo hypofractionated radiotherapy

RADIATIONradiation therapy

Patients undergo standard radiotherapy

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Duration of survival	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026