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Radiation Therapy Plus Chemotherapy in Treating Patients With Supratentorial Glioblastoma Multiforme
This study has been completed.
Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002545
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy and carmustine in treating patients who have supratentorial glioblastoma multiforme.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carmustine
Procedure: low-LET photon therapy
Phase III

MedlinePlus related topics: Cancer
Drug Information available for: Carmustine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A PHASE III TRIAL COMPARING THE USE OF RADIOSURGERY FOLLOWED BY CONVENTIONAL RADIOTHERAPY WITH BCNU TO CONVENTIONAL RADIOTHERAPY WITH BCNU FOR SUPRATENTORIAL GLIOBLASTOMA MULTIFORME

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

Estimated Enrollment: 200
Study Start Date: February 1994
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine whether the use of radiosurgery (stereotactic external-beam irradiation) prior to conventional radiotherapy with carmustine (BCNU) improves overall survival compared to conventional radiotherapy plus BCNU alone in patients with supratentorial glioblastoma multiforme. II. Determine and compare the frequency and severity of toxicities associated with these regimens. III. Compare the effects of these two regimens on neurologic function and quality of life.

OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy. Tumor irradiation using megavoltage equipment (at least 4 MV photons); plus Carmustine, BCNU, NSC-409962. Arm II: Radiosurgery followed by Radiotherapy plus Single-Agent Chemotherapy. Stereotactic tumor irradiation; followed by tumor irradiation as in Arm I; plus BCNU.

PROJECTED ACCRUAL: 200 patients will be entered over approximately 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histopathologically confirmed supratentorial glioblastoma multiforme or gliosarcoma Diagnosis by surgical biopsy or resection required The following tumor types are specifically excluded: Astrocytoma with atypical or anaplastic features Well differentiated astrocytomas Tumors originating in the brain stem Tumors located within 10 mm of the optic chiasm Infratentorial tumors Multifocal malignant glioma Recurrent malignant glioma Well circumscribed contrast-enhancing tumor on pre- and postoperative contrast-enhanced CT or MRI with a maximum diameter (in any direction) of 40 mm required Tumors that do not enhance on postoperative CT or MRI excluded Concurrent enrollment on RTOG-9308 encouraged

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hb at least 10 g/dl (may transfuse) Hepatic: Bilirubin no greater than 2.0 mg/dl SGOT or SGPT no greater than 2 x normal Renal: Creatinine no greater than 1.5 mg/dl BUN no greater than 25 mg/dl Pulmonary: Chest x-ray normal If abnormal or if there is a history of pulmonary disease, pulmonary function studies (including DLCO) must be at least 75% of predicted Other: Neurologic function status 0-3 No AIDS No major medical or psychiatric illness that would preclude protocol therapy or follow-up No second malignancy within 5 years except: Nonmelanomatous skin cancer In situ carcinoma of the uterine cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck Surgery: No more than 5 weeks between surgery and initiation of treatment Recovery from surgery and any postoperative complications required

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002545

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Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Luis Souhami, MD McGill Cancer Centre at McGill University
  More Information

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

Publications of Results:
Other Publications:
Seiferheld W, Chakravarti A, Ang KK, et al.: Overexpression of the epidermal growth factor receptor (EGFR), as determined by EGFR immunostaining on tissue microarrays, fails to demonstrate prognostic value for patients with glioblastoma multiforme: a report from RTOG 7401, 7918, 8302, 8409, 9006, 9305, 9602, and 9806. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-166, 616, 2002.

Study ID Numbers: CDR0000063286, RTOG-9305
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002545  
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 January 16, 2009