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Can changing the order of rectal cancer treatment boost survival?

NCT ID NCT02008656

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial tests whether giving chemotherapy before or after standard chemoradiation improves outcomes for people with locally advanced rectal cancer. Participants receive either the standard approach (chemoradiation, surgery, then chemo) or a total neoadjuvant therapy approach where chemo is given before or after radiation, followed by surgery or a watch-and-wait strategy. The main goal is to see if the new sequences increase the percentage of patients alive and cancer-free three years after starting treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chemotherapy (oxaliplatin, 5-fluorouracil, leucovorin, capecitabine) plus radiation therapy
What this could lead to
If successful, this could establish a more effective treatment sequence for locally advanced rectal cancer, potentially improving the chance of staying cancer-free for at least three years.
What could go wrong
This is a phase II trial, so results are not definitive. The added chemotherapy may increase side effects, and the benefit over standard treatment is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

358 people

The number who actually took part.

Started

Nov 2013

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal cancer

Contacts and locations

Locations

  • CHI Heath Bergan Mercy

    Omaha, Nebraska, 68114, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Colon and Rectal Surgery, Incorporated

    Omaha, Nebraska, 68114, United States

  • John Muir Health

    Walnut Creek, California, 94598, United States

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center at Phelps

    Sleepy Hollow, New York, 10591, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • St. Joseph Hospital

    Orange, California, 92868-3849, United States

  • University Of South Florida

    Tampa, Florida, 33620, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of California, Irvine

    Irvine, California, 92697, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Michigan

    Northville, Michigan, 48168, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • University of Washington School of Medicine

    Seattle, Washington, 98109, United States

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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