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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00820963
First received: January 9, 2009
Last updated: May 11, 2011
Last verified: July 2009
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 October 02, 2014