Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management

Summary

The study is designed to test the hypothesis that patients with Locally advanced rectal cancer ( LARC) treated with Total neoadjuvant therapy (TNT) and Total mesorectal excision (TME) or Non-operative management (NOM) will have an improved 3-year disease-free survival (DFS) compared to patients with similar tumors treated with Chemoradiation therapy (CRT), Total mesorectal excision (TME) and Adjuvant chemotherapy (ACT).

Conditions

• Rectal Cancer

Interventions

DRUG

Oxaliplatin (OXAL)

DRUG

5-Fluorouracil (5-FU)

DRUG

Leucovorin

DRUG

Capecitabine (Xeloda®)

RADIATION

intensity modulated radiotherapy (IMRT)

BEHAVIORAL

Quality of Life Questionnaires

PROCEDURE

DRE-Endoscopy

Sponsors & Collaborators

• Colon and Rectal Surgery Inc.

  collaborator INDUSTRY

• The Cleveland Clinic

  collaborator OTHER

• John Muir Health

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• St. Joseph Hospital of Orange

  collaborator OTHER

• University of California, Irvine

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• University of South Florida

  collaborator OTHER

• University of Vermont

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Medstar Health Research Institute

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Creighton University Medical Center

  collaborator OTHER

• The Methodist Hospital Research Institute

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• St. Paul's Hospital

  collaborator UNKNOWN

• St. Joseph, Florida

  collaborator UNKNOWN

• Cleveland Clinic Florida

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Julio Garcia Aguilar, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2026-11-30

Completion

2026-11-30

Countries

• United States

Study Locations