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

Sponsor:	Centre Leon Berard
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00820963

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: temozolomide Radiation: hypofractionated radiation therapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Duration of survival [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	July 2006
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients undergo standard radiotherapy 5 days a week for 6 weeks.	Radiation: radiation therapy Patients undergo standard radiotherapy
Experimental: Arm II Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.	Radiation: hypofractionated radiation therapy Patients undergo hypofractionated radiotherapy
Experimental: 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.	Drug: temozolomide Given orally

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820963

Locations

France
Centre Leon Berard
Lyon, France, 69373

Sponsors and Collaborators

Centre Leon Berard

Investigators

Investigator:

Didier Frappaz, MD

Centre Leon Berard

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00820963 History of Changes
Other Study ID Numbers:	CDR0000626713, LEONB-ET2005-006, LEONB-Nordic Glioma Adulte, INCA-RECF0031, EUDRACT-2006-003606-25, SPRI-LEONB-ET2005-006
Study First Received:	January 9, 2009
Last Updated:	May 11, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012