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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820963
• Other study ID #: CDR0000626713
• Secondary ID: LEONB-ET2005-006
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2009
• Last updated: May 11, 2011
• Start date: July 2006

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• temozolomide
Given orally

Radiation:
• hypofractionated radiation therapy
Patients undergo hypofractionated radiotherapy
• radiation therapy
Patients undergo standard radiotherapy

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of survival			No