Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. Drugs used in chemotherapy use 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: Phase I/II trial to study the effectiveness of radiation therapy that has been planned with a computer plus chemotherapy in treating patients who have glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carmustine Radiation: radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I/II Radiation Dose Escalation Study Applying Conformal Radiation Therapy in Supratentorial Glioblastoma Multiforme |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 1998 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the feasibility and toxicity of escalating doses of conformal radiotherapy planned with 3-D treatment planning plus carmustine in patients with glioblastoma multiforme.
- Determine dose/volume and dose/anatomic characteristics that influence radiotherapy-induced CNS toxicity.
- Evaluate local control, survival, and failure patterns of these patients treated with high doses of conformal radiotherapy to gross disease.
- Correlate changes on cross-sectional diagnostic MRI imaging studies to clinical or biologic endpoints.
OUTLINE: This is a dose-escalation study. Patients are stratified according to the planned target volume, i.e., gross residual tumor plus 3 mm (less than 75 cc vs at least 75 cc).
Patients undergo radiotherapy over 15-30 minutes daily 5 days a week for 6-8 weeks. After 46 Gy of radiotherapy have been administered, patients undergo radiotherapy field reduction and are accrued into one of four dose levels. (Dose level 1 closed to accrual 1/16/01) All patients receive at least 33 radiation treatments. Each patient is evaluated for acute dose-limiting toxicity for 90 days from start of therapy.
Patients also receive carmustine IV over 1-2 hours daily on days 1-3 for the first week of radiotherapy. Treatment repeats every 8 weeks for up to 6 courses.
Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within at least 5 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme with areas of necrosis as diagnosed by surgical biopsy or subtotal excision
- Supratentorial tumor
- Gross measurable residual disease
- No well-differentiated or anaplastic astrocytoma, multifocal glioma, or recurrent glioblastoma multiforme
- Therapy must begin within 5 weeks after surgery but within 1 week after registration
CT or MRI scan preoperatively and MRI postoperatively prior to initiation of radiotherapy
- If undergoing a stereotactic-guided needle biopsy, not required to repeat MRI after procedure if the prebiopsy MRI is suitable for treatment planning
- Prior complete surgical resection of tumor allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic:
- Bilirubin no greater than 2 mg/dL
- SGPT or SGOT no greater than 2 times normal
Renal:
- BUN no greater than 30 mg/dL
- Creatinine no greater than 1.8 mg/dL
Pulmonary:
- Normal chest x-ray OR
- DLCO at least 60% predicted
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other 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
- Neurologic functional status 0-3
- No major medical illness or psychiatric impairments that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior systemic chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to head or neck
Surgery:
- See Disease Characteristics
Contacts and Locations
Show 237 Study Locations| Study Chair: | Jeff M. Michalski, MD | Washington University Siteman Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003417 History of Changes |
| Other Study ID Numbers: | CDR0000066432, RTOG-9803 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 26, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
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 Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013