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

Primary Purpose

Brain and Central Nervous System Tumors

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

temozolomide

hypofractionated radiation therapy

radiation therapy

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Leon Berard

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Duration of survival

Secondary Outcome Measures

Full Information

NCT ID

NCT00820963

First Posted

January 9, 2009

Last Updated

May 11, 2011

Sponsor

Centre Leon Berard

1. Study Identification

Unique Protocol Identification Number

NCT00820963

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Centre Leon Berard

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain and Central Nervous System Tumors

Keywords

adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

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

Arm Title

Arm II

Arm Type

Experimental

Arm Description

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

Arm Title

Arm III

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

temozolomide

Intervention Description

Given orally

Intervention Type

Radiation

Intervention Name(s)

hypofractionated radiation therapy

Intervention Description

Patients undergo hypofractionated radiotherapy

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

Patients undergo standard radiotherapy

Primary Outcome Measure Information:

Title

Duration of survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Didier Frappaz, MD

Organizational Affiliation

Centre Leon Berard

Facility Information:

Facility Name

Centre Leon Berard

City

Lyon

ZIP/Postal Code

69373

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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