Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma - Carboplatin, Docetaxel and Capecitabine (CTX) or Epirubicin, Oxaliplatin and Capecitabine: a Randomised Phase 2 Trial.
试验速览
- 阶段
- 2 期
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- The proportion of participants alive one year after randomisation
研究概览
简要总结
The main purpose of this study is to determine the effects of treatment with carboplatin, docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically verified, unresectable or metastatic, HER2-negative, adenocarcinoma of the esophagus or stomach
- •Men or women less than 80 years of age
- •Performance status 0 or 1
- •Life expectancy >12 weeks
- •Adequate organ-function
- •Written informed consent
排除标准
- •Prior chemotherapy for adenocarcinoma of the esophagus or stomach if the chemotherapy-free interval is less than 6 months
- •Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the esophagus or stomach
- •Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry
- •Prior cumulative dose of >300 mg/m2 of epirubicin
- •Grade ≥ 2 side-effects from previous chemotherapy
研究组 & 干预措施
Experimental chemotherapy
Intravenous carboplatin (C) AUC5 day 1 plus intravenous docetaxel (T) 60 mg/m2 day 1 plus oral capecitabine (X) 1000 mg/m2 twice daily from day 1-14, every 4 weeks.
干预措施: Carboplatin (Drug)
Experimental chemotherapy
Intravenous carboplatin (C) AUC5 day 1 plus intravenous docetaxel (T) 60 mg/m2 day 1 plus oral capecitabine (X) 1000 mg/m2 twice daily from day 1-14, every 4 weeks.
干预措施: Docetaxel (Drug)
Experimental chemotherapy
Intravenous carboplatin (C) AUC5 day 1 plus intravenous docetaxel (T) 60 mg/m2 day 1 plus oral capecitabine (X) 1000 mg/m2 twice daily from day 1-14, every 4 weeks.
干预措施: Capecitabine (Drug)
Standard chemotherapy
Intravenous epirubicin (E) 50 mg/m2 day 1 plus intravenous oxaliplatin (O) 130 mg/m2 day 1 plus oral capecitabine (X) 625 mg/m2 twice daily continuously, every 3 weeks
干预措施: Capecitabine (Drug)
Standard chemotherapy
Intravenous epirubicin (E) 50 mg/m2 day 1 plus intravenous oxaliplatin (O) 130 mg/m2 day 1 plus oral capecitabine (X) 625 mg/m2 twice daily continuously, every 3 weeks
干预措施: Epirubicin (Drug)
Standard chemotherapy
Intravenous epirubicin (E) 50 mg/m2 day 1 plus intravenous oxaliplatin (O) 130 mg/m2 day 1 plus oral capecitabine (X) 625 mg/m2 twice daily continuously, every 3 weeks
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
The proportion of participants alive one year after randomisation
时间窗: Three and a half years
次要结局
- Changes in quality-of-life(Three and a half years)
- The proportion of participants who have carboplatin, docetaxel and capecitabine re-induced(Five years)
- Registration of further lines of therapy(Five years)
- Time to progression or death due to any cause(Three and a half years)
- Number of participants with grade 3 and 4 toxicities caused by treatments(Day 1 of every cycle and 30 days after completion of treatment)
- Time until death due to any cause(Three and a half years)
研究者
Peter Clausager Petersen
MD
Rigshospitalet, Denmark