A Randomized Phase III Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response
研究概览
简要总结
The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation. Half of participants will receive capecitabine alone together with neoadjuvant CRT, followed by a cycle of XELOX, while the other will receive capecitabine and irinotecan during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological confirmed adenocarcinoma
- •clinical stage T3-4 and/or N+
- •the distance from anal verge less than 12 cm
- •without distance metastases
- •KPS >=70
- •UGT1A1*28 6/6 or 6/7
- •without previous anti-cancer therapy
- •sign the inform consent
排除标准
- •pregnancy or breast-feeding women
- •serious medical illness
- •baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- •DPD deficiency
- •UGT1A1*28 7/7
研究组 & 干预措施
Capecitabine Alone
Concurrent Chemoradiotherapy:
Radiation: 50Gy/25Fx; Capecitabine: 825mg/m2 bid Monday-Friday per week
Chemotherapy in Interval Between CRT and Surgery:
Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1
Surgery:
Scheduled 6-8 weeks after the completion of CRT
Adjuvant Chemotherapy:
Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1; q3w, 5cycles
干预措施: Radiation (Radiation)
Capecitabine Alone
Concurrent Chemoradiotherapy:
Radiation: 50Gy/25Fx; Capecitabine: 825mg/m2 bid Monday-Friday per week
Chemotherapy in Interval Between CRT and Surgery:
Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1
Surgery:
Scheduled 6-8 weeks after the completion of CRT
Adjuvant Chemotherapy:
Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1; q3w, 5cycles
干预措施: Capecitabine (Drug)
Capecitabine Alone
Concurrent Chemoradiotherapy:
Radiation: 50Gy/25Fx; Capecitabine: 825mg/m2 bid Monday-Friday per week
Chemotherapy in Interval Between CRT and Surgery:
Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1
Surgery:
Scheduled 6-8 weeks after the completion of CRT
Adjuvant Chemotherapy:
Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1; q3w, 5cycles
干预措施: Oxaliplatin (Drug)
Capecitabine with Irinotecan
Concurrent Chemoradiotherapy:
Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
Chemotherapy in Interval Between CRT and Surgery:
Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1
Surgery:
Scheduled 6-8 weeks after the completion of CRT
Adjuvant Chemotherapy:
Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1; q3w, 5cycles
干预措施: Radiation (Radiation)
Capecitabine with Irinotecan
Concurrent Chemoradiotherapy:
Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
Chemotherapy in Interval Between CRT and Surgery:
Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1
Surgery:
Scheduled 6-8 weeks after the completion of CRT
Adjuvant Chemotherapy:
Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1; q3w, 5cycles
干预措施: Capecitabine (Drug)
Capecitabine with Irinotecan
Concurrent Chemoradiotherapy:
Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
Chemotherapy in Interval Between CRT and Surgery:
Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1
Surgery:
Scheduled 6-8 weeks after the completion of CRT
Adjuvant Chemotherapy:
Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1; q3w, 5cycles
干预措施: Irinotecan (Drug)
Capecitabine with Irinotecan
Concurrent Chemoradiotherapy:
Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
Chemotherapy in Interval Between CRT and Surgery:
Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1
Surgery:
Scheduled 6-8 weeks after the completion of CRT
Adjuvant Chemotherapy:
Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1; q3w, 5cycles
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Pathologic Complete Response
时间窗: Surgery scheduled 6-8 weeks after the end of chemoradiation
次要结局
- Overall Survival(From date of randomization until the date of death from any cause, assessed up to 10 years)
- Disease-free Survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years)
- Local Control rate(From date of randomization until the date of first documented pelvic failure, assessed up to 10 years)
- Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0(Up to 2 years)
- Surgical complications(Surgery scheduled 6-8 weeks after the end of chemotherapy)