Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: First Affiliated Hospital of Chongqing Medical University; Hubei Cancer Hospital; Ruijin Hospital; The First Affiliated Hospital with Nanjing Medical University
• Treatments: Camptothecin; Capecitabine; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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