An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design paradigm, as well as the rate of 2-year organ preservation, recurrence, quality of life, DFS and OS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Capecitabine; Fluorouracil; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• pathological confirmed adenocarcinoma

• clinical stage T2-4 and/or N+, inappropriate for local excision

• the distance from anal verge less than 5 cm, or considered inappropriate for anal preservation by surgeons.

• Strong desire to preserve the anus, able to receive close surveillance for at least 2 years after chemoradiotherapy.

• without distance metastases

• aged between 18 to 75 years old.

• performance status score: 0~1

• UGT1A1*28 6/6 or 6/7

• sign the inform consent

Exclusion Criteria:

• pregnancy or breast-feeding women

• serious medical illness

• difficult to achieve complete response assessed by current evidence: the maximal diameter of tumor >10cm; the maximal diameter of lateral lymph node >2cm; baseline CEA>=100; biopsy pathology confirmed signet ring cell carcinoma components; digital rectal examination found that the tumor is peri-narrowed.

• 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