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Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
This study is ongoing, but not recruiting participants.
Study NCT00006386   Information provided by National Cancer Institute (NCI)
First Received: October 4, 2000   Last Updated: February 6, 2009   History of Changes

October 4, 2000
February 6, 2009
March 2001
 
 
 
Complete list of historical versions of study NCT00006386 on ClinicalTrials.gov Archive Site
 
 
 
Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For 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.

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.

Phase II
Interventional
Treatment
Brain and Central Nervous System Tumors
  • Drug: carmustine
  • Radiation: radiation therapy
  • Radiation: stereotactic radiosurgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
  • SGPT or SGOT less than 2 times normal

Renal:

  • Creatinine less than 1.8 mg/dL
  • BUN less than 30 mg/dL

Pulmonary:

  • Chest x-ray normal OR
  • 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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00006386
 
CDR0000068264, RTOG-BR-0023, RTOG-DEV-1040
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Rupert Schmidt-Ullrich, MD Massey Cancer Center
National Cancer Institute (NCI)
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP