Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
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| ClinicalTrials.gov Identifier: NCT00006386 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : November 17, 2015
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain and Central Nervous System Tumors | Drug: carmustine Radiation: radiation therapy Radiation: stereotactic radiosurgery | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme |
| Study Start Date : | March 2001 |
| Actual Primary Completion Date : | November 2004 |
| Actual Study Completion Date : | February 2009 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: carmustine Radiation: radiation therapy Radiation: stereotactic radiosurgery |
- 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. ]
- 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. ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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 ClinicalTrials.gov identifier (NCT number): NCT00006386
Show 236 Study Locations
| Study Chair: | Robert M. Cardinale, MD | MCV Hospitals |
Publications of Results:
| Responsible Party: | Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00006386 History of Changes |
| Other Study ID Numbers: |
RTOG-BR-0023 CDR0000068264 RTOG-DEV-1040 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | November 17, 2015 |
| Last Verified: | November 2015 |
Keywords provided by Radiation Therapy Oncology Group:
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adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
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Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Carmustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |