A Prospective, Multicenter, Randomized Controlled Trial of Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 site in 1 country255 target enrollmentAugust 15, 2020

ConditionsRectal Cancer

InterventionsConcurrent Chemoradiotherapy XELOX mFOLFOX TME

DrugsXELOX mFOLFOX

Overview

Phase: Phase 2
Intervention: Concurrent Chemoradiotherapy
Conditions: Rectal Cancer
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Enrollment: 255
Locations: 1
Primary Endpoint: The rate of tumor down-staging
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Phase II Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer

Detailed Description

Recommended treatment of patients with locally advanced rectal cancer (LARC) includes preoperative chemoradiation (CRT), total mesorectal excision (TME) and postoperative adjuvant chemotherapy (ACT). However, treatments fail to show an improved therapeutic effect on high-risk patients now. Total neoadjuvant therapy (TNT) is a new try for rectal cancer treatment,and this trial aims to identify and select the more promising TNT sequence. This trail is a multicenter, randomized, phase II trial . Eligible patients age from 18 to 75 years with histologically confirmed rectal adenocarcinoma. MRI is mandatory, and patients of stage II or III rectal cancer are eligible if any of the following criteria are fulﬁlled: Categories T4,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement. Patients are randomly assigned to 3 groups, group 1: concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group);or group 2: concurrent chemoradiotherapy → consolidation chemotherapy → TME (CNCT group);Or group 3: induction chemotherapy → concurrent chemoradiotherapy →TME ( INCT group).The primary end point is the rate of tumor down-staging, which is deﬁned as stage yp0-II after surgery,and watch-and-wait strategy after complete clinical response (cCR) was allowed. Secondary end points include acute toxicity, compliance with TNT, surgical complications, 3-year overall survival (3yOS),3-year disease free survival (3yDFS),3-year distant metastatic free survival(3yDMFS),3-year locoregional recurrence-free survival(3yLRRFS) and quality of life.

Registry

clinicaltrials.gov

Start Date

August 15, 2020

End Date

June 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Responsible Party

Principal Investigator

JIN JING

Clinical Professor，Radiotherapy Department

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•History of malignant tumor in other parts;
•Cannot complete MRI; Allergic to 5-fu drugs; Allergic to platinum drugs;
•During thrombolytic and anticoagulant therapy, the patient has bleeding diathesis or coagulation dysfunction; Or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year;
•History of kidney, urine test found proteinuria or clinical renal function was significantly abnormal;
•History of digestive tract fistula, perforation or severe ulcer;
•Active infection is present; Clinically obvious heart disease; New York heart association (NYHA) of Ⅱ level or congestive heart failure; Unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; Myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.