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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

358

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

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

Trial Locations (26)

10065

Memorial Sloan Kettering Cancer Center, New York

10591

Memorial Sloan Kettering Cancer Center at Phelps, Sleepy Hollow

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Commack, Commack

14642

University of Rochester Medical Center, Rochester

20010

Washington Hospital Center, Washington D.C.

22908

University of Virginia, Charlottesville

33331

Cleveland Clinic Florida, Weston

33620

University Of South Florida, Tampa

44195

Cleveland Clinic, Cleveland

48168

University of Michigan, Northville

60637

University of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

68114

CHI Heath Bergan Mercy, Omaha

Colon and Rectal Surgery, Incorporated, Omaha

80045

University of Colorado, Aurora

92697

University of California, Irvine, Irvine

94143

University of California San Francisco, San Francisco

94598

John Muir Health, Walnut Creek

97239

Oregon Health & Science University, Portland

98109

University of Washington School of Medicine, Seattle

92868-3849

St. Joseph Hospital, Orange

07920

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07645

Memorial Sloan Kettering Bergen, Montvale

05401

University of Vermont Medical Center, Burlington

Sponsors
All Listed Sponsors
collaborator

Colon and Rectal Surgery Inc.

INDUSTRY

collaborator

The Cleveland Clinic

OTHER

collaborator

John Muir Health

OTHER

collaborator

Oregon Health and Science University

OTHER

collaborator

St. Joseph Hospital of Orange

OTHER

collaborator

University of California, Irvine

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

University of Chicago

OTHER

collaborator

University of South Florida

OTHER

collaborator

University of Vermont

OTHER

collaborator

University of Washington

OTHER

collaborator

Medstar Health Research Institute

OTHER

collaborator

Washington University School of Medicine

OTHER

collaborator

Creighton University Medical Center

OTHER

collaborator

The Methodist Hospital Research Institute

OTHER

collaborator

University of Rochester

OTHER

collaborator

University of Virginia

OTHER

collaborator

St. Paul's Hospital

UNKNOWN

collaborator

St. Joseph, Florida

UNKNOWN

collaborator

Cleveland Clinic Florida

OTHER

collaborator

University of Colorado, Denver

OTHER

collaborator

University of Michigan

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER