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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.

Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006386
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carmustine
Procedure: radiation therapy
Procedure: stereotactic radiosurgery
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Carmustine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 2001

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006386

Show 236 study locations  Show 236 Study Locations

Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Rupert Schmidt-Ullrich, MD     Massey Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
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.
 

Study ID Numbers:   CDR0000068264, RTOG-BR-0023, RTOG-DEV-1040
First Received:   October 4, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006386
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma  
adult giant cell glioblastoma  
adult gliosarcoma  

Study placed in the following topic categories:
Neuroectodermal Tumors
Glioblastoma
Glioblastoma multiforme
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Carmustine
Neuroepithelioma
Glioma
Central Nervous System Neoplasms
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Nervous System Diseases
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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