Phase II-III Study Comparing Radiochemotherapy With the FOLFOX Regimen Versus Radiochemotherapy With 5FU-cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Oesophageal Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 266
- 试验地点
- 28
- 主要终点
- Endoscopic complete response rate (Phase II)
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different combination chemotherapy regimens to compare how well they work as first-line therapy in treating patients with esophageal cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To assess the feasibility of radiochemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium (FOLFOX regimen) vs fluorouracil and cisplatin (Herskovic regimen) in patients with inoperable esophageal cancer. (Phase II)
- To assess the endoscopic complete response rate in patients treated with these regimens. (Phase II)
- To compare the event-free survival of patients treated with these regimens. (Phase III)
Secondary
- To assess the toxicity profile of these regimens using the NCI CTC v2.0 criteria. (Phase II)
- To compare the overall survival, endoscopic complete response rate, incidence of grade 3-4 toxicities, and time to treatment failure in patients treated with these regimens. (Phase III)
- To evaluate the quality of life of these patients using EORTC QLQ-C30 (version 3) and a validated disease-specific module EORTC QLQ-OES18. (Phase III)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
FOLFOX and radiotherapy
Oxaliplatin (85mg/m2); Folinic Acid (200mg/m2); 5-FU (400mg/m2-Bolus and 1600mg/m2 over 46h)- once every two weeks for six cycles
干预措施: 5-FU (Drug)
FOLFOX and radiotherapy
Oxaliplatin (85mg/m2); Folinic Acid (200mg/m2); 5-FU (400mg/m2-Bolus and 1600mg/m2 over 46h)- once every two weeks for six cycles
干预措施: oxaliplatin (Drug)
FOLFOX and radiotherapy
Oxaliplatin (85mg/m2); Folinic Acid (200mg/m2); 5-FU (400mg/m2-Bolus and 1600mg/m2 over 46h)- once every two weeks for six cycles
干预措施: radiation therapy (Radiation)
FOLFOX and radiotherapy
Oxaliplatin (85mg/m2); Folinic Acid (200mg/m2); 5-FU (400mg/m2-Bolus and 1600mg/m2 over 46h)- once every two weeks for six cycles
干预措施: Folinic Acid (Drug)
5-FU / cisplatin and radiotherapy
5-FU (100mg/m2); Cisplatin (75mg/m2)
干预措施: cisplatin (Drug)
5-FU / cisplatin and radiotherapy
5-FU (100mg/m2); Cisplatin (75mg/m2)
干预措施: 5-FU (Drug)
5-FU / cisplatin and radiotherapy
5-FU (100mg/m2); Cisplatin (75mg/m2)
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Endoscopic complete response rate (Phase II)
时间窗: 12 weeks
Percentage of patients who complete the full study treatment (Phase II)
时间窗: 12 weeks
Progression-free survival (Phase III)
时间窗: Until progression
次要结局
- Overall survival (Phase III)(Total duration of the trial)
- Incidence of grade 3-4 toxicities (Phase III)(Total duration of the trial)
- Safety profile as assessed by NCI CTC v2.0 (Phase II)(Total duration of the trial)
- Complete response rate (Phase III)(Total duration of the trial)
- Time to treatment failure (Phase III)(Total duration of the trial)
- Quality of life as assessed by EORTC QLQ-C30 (version 3) and EORTC QLQ-OES18 (Phase III)(Total duration of the trial)