Phase I/II Radiation Dose Escalation Study Applying Conformal Radiation Therapy in Supratentorial Glioblastoma Multiforme
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 237
研究概览
简要总结
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.
详细描述
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 (central nervous system) 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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •Bilirubin no greater than 2 mg/dL
- •SGPT (serum glutamate pyruvate transaminase) or SGOT (serum glutamic oxaloacetic transaminase) no greater than 2 times normal
- •BUN (blood urea nitrogen) no greater than 30 mg/dL
- •Creatinine no greater than 1.8 mg/dL
- •Normal chest x-ray OR
- •DLCO (carbon monoxide diffusing capacity) at least 60% predicted
- •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
- •See Disease Characteristics
排除标准
- 未提供