Phase 1-2 Study of the Association of Gemzar ® - Cisplatin-concurrent Radiotherapy in Patients With Non-metastatic Tumors of the Bladder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Incidence and nature of acute and late toxicity (Phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with cisplatin and radiation therapy and to see how well they work in treating patients with stage II or stage III bladder cancer.
详细描述
OBJECTIVES:
Primary
- Determine the incidence and nature of acute and late toxicity of gemcitabine hydrochloride, cisplatin, and concurrent radiotherapy in patients with stage II or III transitional cell carcinoma of the bladder. (Phase I)
- Determine the efficacy of this regimen, in terms of local tumor control (absence of local progression), in these patients. (Phase II)
Secondary
- Determine the maximum tolerated dose and the recommended phase II dose of gemcitabine hydrochloride when administered with cisplatin and radiotherapy in these patients. (Phase I)
- Assess the 5- and 10-year survival and the progression-free survival of patients treated with this regimen. (Phase II)
- Assess the quality of life of patients treated with this regimen. (Phase II)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
gemcitabine, cisplatine, radiotherapy
干预措施: cisplatin (Drug)
gemcitabine, cisplatine, radiotherapy
干预措施: gemcitabine hydrochloride (Drug)
gemcitabine, cisplatine, radiotherapy
干预措施: biopsy (Procedure)
gemcitabine, cisplatine, radiotherapy
干预措施: cystoscopy (Procedure)
gemcitabine, cisplatine, radiotherapy
干预措施: therapeutic conventional surgery (Procedure)
gemcitabine, cisplatine, radiotherapy
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Incidence and nature of acute and late toxicity (Phase I)
时间窗: From baseline to the end of treatment
Local tumor control (Phase II)
时间窗: From baseline to the end of treatment
次要结局
- Maximum tolerated dose and recommended phase II dose of gemcitabine hydrochloride when administered with cisplatin and radiotherapy (Phase I)(From baseline to the end of treatment)
- Quality of life (Phase II)(From baselin to the end of treatment)
- Progression-free survival (Phase II)(6 to 8 weeks after to the end of treatment)
- 5- and 10-year survival (Phase II)(until 5 and 10 year after the end of treatment)