Radiation Therapy Plus Chemotherapy in Treating Patients With 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. Identifier: NCT00002545
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : August 13, 2013
National Cancer Institute (NCI)
Information provided by:
Radiation Therapy Oncology Group

Brief Summary:

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 or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: carmustine Radiation: low-LET photon therapy Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : February 1994
Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Carmustine
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002545

  Show 260 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Luis Souhami, MD McGill Cancer Centre at McGill University

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. Identifier: NCT00002545     History of Changes
Other Study ID Numbers: RTOG-9305
First Posted: July 19, 2004    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Radiation Therapy Oncology Group:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents