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NOT YET RECRUITING
NCT04443543
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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

DRUG

Capecitabine (Xeloda) Pharmacogenetic Test Reagents

CRT: 625mg/m2 bid Monday-Friday per week XELIRI: 1000mg/m2 bid d1-14

DRUG

irinotecan

CRT:80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) XELIRI: 200mg/m2 bid d1 FOLFIRINOX: 150mg/m2 d1

RADIATION

IMRT

Pelvic Radiation: 50Gy/25Fx

DRUG

Oxaliplatin

FOLFIRINOX: 85mg/m2 d1

DRUG

5Fluorouracil

FOLFIRINOX: 400mg/m2 iv d1bolus, 2400mg/m2 ivgtt 46h

DRUG

Tislelizumab

200mg iv

Locations (1)

Fudan University Shanghai Cancer Cencer

Shanghai, Shanghai Municipality, China