Standard Radiation Therapy, Higher-Dose Radiation Therapy, or Chemotherapy in Treating Older Patients With Glioblastoma Multiforme
This study has been completed.
Sponsor:
Centre Leon Berard
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
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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 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 June 18, 2013