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Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006386
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Tracking Information
First Submitted Date  ICMJE October 4, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date November 17, 2015
Study Start Date  ICMJE March 2001
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
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. ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
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. ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
Official Title  ICMJE A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: carmustine
  • Radiation: radiation therapy
  • Radiation: stereotactic radiosurgery
Study Arms  ICMJE Experimental: External beam radiotherapy with stereotactic boost
External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.
Interventions:
  • Drug: carmustine
  • Radiation: radiation therapy
  • Radiation: stereotactic radiosurgery
Publications * Cardinale R, Won M, Choucair A, et al.: A phase II trial of accelerated radiotherapy using weekly stereotactic conformal boosts for supratentorial glioblastoma multiforme. RTOG-0023. [Abstract] J Clin Oncol 23 (Suppl 16): A-1511, 116s, 2005.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2013)
80
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00006386
Other Study ID Numbers  ICMJE RTOG-BR-0023
CDR0000068264
RTOG-DEV-1040
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radiation Therapy Oncology Group
Study Sponsor  ICMJE Radiation Therapy Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Robert M. Cardinale, MD MCV Hospitals
PRS Account Radiation Therapy Oncology Group
Verification Date November 2015

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