NCT Number: NCT00006386
Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by carmustine in treating patients who have supratentorial glioblastoma multiforme.
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Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada
About this study
OBJECTIVES:
- Determine the overall and progression-free survival in patients with supratentorial glioblastoma multiforme treated with accelerated radiotherapy and conformal stereotactic radiotherapy boost followed by carmustine.
- Determine the short and long-term toxicity of this regimen in these patients.
- Determine the feasibility of this regimen in these patients.
OUTLINE: Patients receive daily accelerated radiotherapy 5 days a week on weeks 1-2. On weeks 3-6, patients receive accelerated radiotherapy 4 days a week (3 days a week on week 6) and conformal stereotactic radiotherapy boost once weekly. Patients then receive carmustine IV over 1-2 hours on days 1-3 every 8 weeks for 6 courses beginning within 1 month after the completion of radiotherapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 15 months.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Histologically confirmed supratentorial glioblastoma multiforme by surgical biopsy or resection within 5 weeks of study
- Postoperative residual contrast enhancing tumor and resection tumor cavity together no greater than 60 mm in maximum diameter
- No well-differentiated or anaplastic astrocytomas or multifocal glioma
- No tumors originating in the brainstem
- No residual tumor within 10 mm of optic chiasm
- No recurrent glioblastoma multiforme
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Hemoglobin greater than 9 g/dL
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL
- Serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) less than 2 times normal
Renal:
- Creatinine less than 1.8 mg/dL
- Blood urea nitrogen (BUN) less than 30 mg/dL
Pulmonary:
- Chest x-ray normal OR
- Diffusion capacity of lung for carbon monoxide (DLCO) greater than 60% predicted
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Neurologic functional status 0-3
- No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Concurrent steroids allowed
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- Concurrent anticonvulsants allowed
Treatment and study plan
radiation therapy
RadiationStereotactic Radiosurgery
RadiationPrimary outcomes
-
Overall Survival
Time frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
Secondary outcomes
-
Progression-free Survival
Time frame: From registration to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome analysis.
Sponsors and collaborators
Lead sponsor
Radiation Therapy Oncology Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme
Important dates
- Study start
- 2001
- Primary completion
- 2004
- Study completion
- 2009
- First posted
- Jan 27, 2003
- Registry last updated
- Oct 22, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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