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

Running, not enrolling · Phase 2

Conditions studied: Rectal Cancer

In brief

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).

Key facts

Study ID: NCT02008656
Run by: Memorial Sloan Kettering Cancer Center
People needed: 358
Starts: 2013-11-01
Expected to finish: 2026-11-01
Last updated by the study team: 2025-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed diagnosis of adenocarcinoma of the rectum
Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on MRI
Rectal tumor at baseline which would be considered to require complete TME
No evidence of distant metastases
No prior pelvic radiation therapy
No prior chemotherapy or surgery for rectal cancer
Age ≥ 18 years The minimum legal age of consent for select Canadian provinces is 19
No active infections requiring systemic antibiotic treatment (oral antibiotics are acceptable at the discretion of the treating physician)
ECOG Performance status 0-2
Women with childbearing potential (WOCBP) who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. A woman of childbearing potential is defined of one who is biologically capable of becoming pregnant. Reliable contraception should be used from trial screening and must be continued throughout the study.
Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. Patients who do not read or understand English are eligible and may be consented according to institutional and federal regulations.
ANC > 1.5 cells/mm3, HGB > 8.0 gm/dl, PLT > 150,000/mm3 total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), AST≤ 3 x ULN, ALT ≤ 3 x ULN.

You may not qualify if…

Recurrent rectal cancer
Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en block resection will not achieve negative margins.
Creatinine level greater than 1.5 times the upper limit of normal.
Patients who have received prior pelvic radiotherapy.
Patients who are unable to undergo an MRI.
Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
Patients with a history of venous thrombotic episodes such as deep venous thrombosis, pulmonary embolus occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.
Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.
WOCBP who are unwilling or unable to use an acceptable method of avoiding pregnancy for the entire study period.
Women who are pregnant or breast-feeding.
Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

Where it is running

University of California, Irvine — Irvine, California, United States
St. Joseph Hospital — Orange, California, United States
University of California San Francisco — San Francisco, California, United States
John Muir Health — Walnut Creek, California, United States
University of Colorado — Aurora, Colorado, United States
Washington Hospital Center — Washington D.C., District of Columbia, United States
University Of South Florida — Tampa, Florida, United States
Cleveland Clinic Florida — Weston, Florida, United States
University of Chicago — Chicago, Illinois, United States
University of Michigan — Northville, Michigan, United States
Washington University School of Medicine — St Louis, Missouri, United States
CHI Heath Bergan Mercy — Omaha, Nebraska, United States
Colon and Rectal Surgery, Incorporated — Omaha, Nebraska, United States
Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
Memorial Sloan Kettering Commack — Commack, New York, United States
Memorial Sloan Kettering Westchester — Harrison, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
University of Rochester Medical Center — Rochester, New York, United States
Memorial Sloan Kettering Cancer Center at Phelps — Sleepy Hollow, New York, United States
Memorial Sloan Kettering Nassau — Uniondale, New York, United States
Cleveland Clinic — Cleveland, Ohio, United States
Oregon Health & Science University — Portland, Oregon, United States
University of Vermont Medical Center — Burlington, Vermont, United States
University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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