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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. completion date
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


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
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