Treatment Discontinuation Associated With Perioperative Toxicity of FLOT Versus XELOX Chemotherapy in Patient With Resectable Gastric Cancer; Phase 2
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Proportion of patients who complete all the treatment per protocol
研究概览
简要总结
Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive Oxaliplatin and Capecitabin (XELOX). Primary endpoint of the study is the proportion of patients who complete all allocated treatment.
详细描述
328 рatients with resectable (T1b-4 and/or N-/+, M0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After staging laparocopy patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by curative surgery. Adjuvant chemotherapy will be given as 4 cycles of FLOT or 4 cycles XELOX. The primary endpoint is the proportion of patients who fully adhered to all the allocated treatment per protocol. Secondary endpoints are pathological regression grade, progression free survival, overall survival, chemotherapy and surgery complications rates.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cT1b-T4b (cT4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery)
- •Age: 18 - 80
- •ECOG: 0 - 1
- •Histological type: adenocarcinoma
- •Differentiation grade: G0 - G4
- •No previous surgery
- •No previous chemotherapy
- •No concomitant severe comorbidity
- •Written informed consent
排除标准
- •cT1a, cT4b (invasion in truncus, hepatic artery, proximal part of splenic artery)
- •Presense of distant metastases
- •ECOG: 2 - 5
- •Age: <18 and >80
- •Severe concomitant comorbidity
研究组 & 干预措施
Perioperative XELOX chemotherapy
Oxaliplatin 130 mg/m2, d1 Capecitabine 1000 mg/m² two times per day (BID), d1-14, every 3 weeks (q3w) 4 cycles (12 weeks) pre-OP and 3 cycles (12 weeks) post-OP
干预措施: Capecitabine (Drug)
Perioperative XELOX chemotherapy
Oxaliplatin 130 mg/m2, d1 Capecitabine 1000 mg/m² two times per day (BID), d1-14, every 3 weeks (q3w) 4 cycles (12 weeks) pre-OP and 3 cycles (12 weeks) post-OP
干预措施: Oxaliplatin (Drug)
Perioperative FLOT chemotherapy
Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP
干预措施: Docetaxel (Drug)
Perioperative FLOT chemotherapy
Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP
干预措施: Oxaliplatin (Drug)
Perioperative FLOT chemotherapy
Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP
干预措施: Leucovorin (Drug)
Perioperative FLOT chemotherapy
Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP
干预措施: Fluorouracil (Drug)
结局指标
主要结局
Proportion of patients who complete all the treatment per protocol
时间窗: Up to 2 months
Completed treatment protocol is considered as 4 cycles neoadjuvant chemotherapy followed by curative surgery and 4 cycles of adjuvant chemotherapy.
次要结局
- Surgical complications rate(up to 90th day after surgery)
- Chemotherapy toxicity profile(at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days))
- 1-year disease-free survival rate(1 year after surgery)
- Correlation between histopathological regression and disease-free survival(2 years of follow-up after the last cycle of chemotherapy)
- Median overall survival(5 year follow up after the last cycle of chemotherapy)
- Histopathological regression rate (Becker regression criteria)(2 weeks after surgery)
研究者
Oleksii Dobrzhanskiy
Principal investigator
National Cancer Institute (NCI)