PHASE II STUDY OF PREIRRADIATION PCV CHEMOTHERAPY IN PATIENTS WITH SUPRATENTORIAL LOW-GRADE GLIOMAS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 17
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of procarbazine, lomustine, and vincristine followed by radiation therapy in treating adults who have supratentorial glioma.
详细描述
OBJECTIVES: I. Estimate the response rate of patients with newly diagnosed supratentorial low-grade glioma following neoadjuvant chemotherapy with PCV (procarbazine/lomustine/vincristine). II. Describe the toxicity of PCV. III. Determine the incidence of disease progression in these patients during PCV treatment.
OUTLINE: The following acronyms are used: CCNU Lomustine, NSC-79037 PCB Procarbazine, NSC-77213 PCV PCB/CCNU/VCR VCR Vincristine, NSC-67574 3-Drug Combination Chemotherapy Followed by Radiotherapy. PCV; followed by external-beam cranial irradiation using at least 6 MV photons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
procarbazine + lomustine + vincristine + radiation
PCV followed by external-beam cranial irradiation using at least 6 MV photons.
干预措施: lomustine (Drug)
procarbazine + lomustine + vincristine + radiation
PCV followed by external-beam cranial irradiation using at least 6 MV photons.
干预措施: procarbazine hydrochloride (Drug)
procarbazine + lomustine + vincristine + radiation
PCV followed by external-beam cranial irradiation using at least 6 MV photons.
干预措施: vincristine sulfate (Drug)
procarbazine + lomustine + vincristine + radiation
PCV followed by external-beam cranial irradiation using at least 6 MV photons.
干预措施: low-LET photon therapy (Radiation)
结局指标
主要结局
Response rate
时间窗: Up to 5 years
次要结局
- Disease progression(Up to 5 years)