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An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer
Sponsor: Fudan University
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.
Official title: Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Chemoradiotherapy: A Multi-centre, Adaptive-design, Phase II Prospective Cohort Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
222
Start Date
2020-06-22
Completion Date
2026-12-31
Last Updated
2020-06-30
Healthy Volunteers
No
Conditions
Interventions
Capecitabine (Xeloda) Pharmacogenetic Test Reagents
CRT: 625mg/m2 bid Monday-Friday per week XELIRI: 1000mg/m2 bid d1-14
irinotecan
CRT:80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) XELIRI: 200mg/m2 bid d1 FOLFIRINOX: 150mg/m2 d1
IMRT
Pelvic Radiation: 50Gy/25Fx
Oxaliplatin
FOLFIRINOX: 85mg/m2 d1
5Fluorouracil
FOLFIRINOX: 400mg/m2 iv d1bolus, 2400mg/m2 ivgtt 46h
Tislelizumab
200mg iv
Locations (1)
Fudan University Shanghai Cancer Cencer
Shanghai, Shanghai Municipality, China