NCT00820963

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 12, 2011

Status Verified

July 1, 2009

Enrollment Period

4.8 years

First QC Date

January 9, 2009

Last Update Submit

May 11, 2011

Conditions

Brain and Central Nervous System Tumors

Keywords

adult giant cell glioblastomaadult glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

  • Duration of survival

Study Arms (3)

Arm I

EXPERIMENTAL

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

Radiation: radiation therapy

Arm II

EXPERIMENTAL

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

Radiation: hypofractionated radiation therapy

Arm III

EXPERIMENTAL

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

Interventions

temozolomideDRUG

Given orally

Arm III
hypofractionated radiation therapyRADIATION

Patients undergo hypofractionated radiotherapy

Arm II
radiation therapyRADIATION

Patients undergo standard radiotherapy

Arm I

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Leon Berard

Lyon, 69373, France

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcoma

Interventions

TemozolomideRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Didier Frappaz, MD

    Centre Leon Berard

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 12, 2009

Study Start

July 1, 2006

Primary Completion

May 1, 2011

Last Updated

May 12, 2011

Record last verified: 2009-07

Locations

FR(1)