A Phase II Trial of Capecitabine and Irinotecan With or Without Amifostine in Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
研究概览
简要总结
The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine 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 it will depends which regimens the patient would receive according to his or her pathological results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •performance status score: 0~1
- •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 and Irinotecan without Amifostine
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: depends on patients pathological review.
干预措施: Radiation (Radiation)
Capecitabine and Irinotecan without Amifostine
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: depends on patients pathological review.
干预措施: Capecitabine (Drug)
Capecitabine and Irinotecan without Amifostine
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: depends on patients pathological review.
干预措施: Irinotecan (Drug)
Capecitabine and Irinotecan with Amifostine
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) Amifostine: 400mg/m2 per week
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: depends on patients pathological review.
干预措施: Radiation (Radiation)
Capecitabine and Irinotecan with Amifostine
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) Amifostine: 400mg/m2 per week
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: depends on patients pathological review.
干预措施: Capecitabine (Drug)
Capecitabine and Irinotecan with Amifostine
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) Amifostine: 400mg/m2 per week
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: depends on patients pathological review.
干预措施: Irinotecan (Drug)
Capecitabine and Irinotecan with Amifostine
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) Amifostine: 400mg/m2 per week
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: depends on patients pathological review.
干预措施: Amifostine (Drug)
结局指标
主要结局
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
时间窗: during neoadjuvant chemoradiation.
次要结局
- pathological response rate(Surgery scheduled 6-8 weeks after the end of chemoradiation.)
- Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire and EORTC-QLQ-C30 questionnaire(during neoadjuvant chemoradiation.)
- the morbidity of late radiation proctitis(late radiation proctitis is measured 9 months after the end of chemoradiation.)