Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer (NEO-RT)

June 8, 2026 updated by: Canadian Cancer Trials Group

A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is being done to find out if this approach is better or worse than the usual approach for early rectal cancer. The usual approach is defined as care most people get for early rectal cancer.

The usual approach for patients who are not in a study is surgery to remove the rectum or treatment with chemotherapy and radiation therapy, followed by surgery. There are several chemotherapy drugs approved by Health Canada that are commonly used with radiation therapy. For patients who get the usual approach for this cancer, about 90 out of 100 are free of cancer after 5 years.

If a patient decides to take part in this study, they will either get a combination of chemotherapy drugs called FOLFOX or CAPOX for up to 12 weeks or will get chemotherapy with radiation therapy for up to 6 weeks.

After finishing treatment, and even if treatment is stopped early, the study doctor will watch for side effects and determine which type of surgery would be best. After surgery, patients will be asked to come in every 4 months for 2 years, then every 6 months for an additional year. Then will be checked every year for 2 years. This means seeing the study doctor for up to 5 years after surgery. Patients may be seen more often if your study doctor thinks it is necessary.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BCCA-Vancouver Cancer Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 888-939-3333
        • Principal Investigator:
          • Jonathan M. Loree
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba
        • Contact:
        • Principal Investigator:
          • Eric Hyun
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Recruiting
        • Doctor H. Bliss Murphy Cancer Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 709-777-7589
        • Principal Investigator:
          • Teri L. Stuckless
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Recruiting
        • London Regional Cancer Program
        • Contact:
          • Site Public Contact
          • Phone Number: 519-685-8600
        • Principal Investigator:
          • Terry M. Zwiep
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital and Cancer Center-General Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 613-761-4395
        • Principal Investigator:
          • Kristopher Dennis
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • CIUSSSEMTL-Hopital Maisonneuve-Rosemont
        • Contact:
          • Site Public Contact
          • Phone Number: 3329 514-252-3400
        • Principal Investigator:
          • Mikael Soucisse
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Recruiting
        • Allan Blair Cancer Centre
        • Principal Investigator:
          • Mussawar Iqbal
        • Contact:
          • Site Public Contact
          • Phone Number: 306-766-2213
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Recruiting
        • Saskatoon Cancer Centre
        • Principal Investigator:
          • Shahid Ahmed
        • Contact:
          • Site Public Contact
          • Phone Number: 306-655-2914
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
    • California
      • Irvine, California, United States, 92612
        • Recruiting
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Principal Investigator:
          • Jason A. Zell
        • Contact:
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
        • Principal Investigator:
          • Joshua P. Schiff
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles General Medical Center
        • Contact:
        • Principal Investigator:
          • Joshua P. Schiff
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Principal Investigator:
          • Jason A. Zell
        • Contact:
      • Santa Maria, California, United States, 93444
    • Delaware
      • Millville, Delaware, United States, 19967
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
    • Florida
      • Orlando, Florida, United States, 32806
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Patrick S. Sullivan
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Patrick S. Sullivan
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
        • Principal Investigator:
          • Patrick S. Sullivan
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush-Copley Medical Center
        • Principal Investigator:
          • Prem Sobti
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Aparna Kalyan
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Prem Sobti
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • Aparna Kalyan
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Prem Sobti
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • Aparna Kalyan
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Prem Sobti
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Prem Sobti
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Aparna Kalyan
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Recruiting
        • Northwest Cancer Center - Crown Point
        • Principal Investigator:
          • Prem Sobti
        • Contact:
      • Dyer, Indiana, United States, 46311
        • Recruiting
        • Northwest Oncology LLC
        • Contact:
          • Site Public Contact
          • Phone Number: 219-924-8178
        • Principal Investigator:
          • Prem Sobti
      • Hobart, Indiana, United States, 46342
        • Recruiting
        • Northwest Cancer Center - Hobart
        • Contact:
          • Site Public Contact
          • Phone Number: 219-947-1795
        • Principal Investigator:
          • Prem Sobti
      • Hobart, Indiana, United States, 46342
        • Recruiting
        • Saint Mary Medical Center
        • Principal Investigator:
          • Prem Sobti
        • Contact:
      • Munster, Indiana, United States, 46321
        • Recruiting
        • The Community Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 219-836-3349
        • Principal Investigator:
          • Prem Sobti
      • Valparaiso, Indiana, United States, 46383
        • Recruiting
        • Northwest Cancer Center - Valparaiso
        • Principal Investigator:
          • Prem Sobti
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
        • Principal Investigator:
          • Sanda A. Tan
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Recruiting
        • Beverly Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 2405 978-922-3000
        • Principal Investigator:
          • Brian Labadie
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Brian Labadie
      • Gloucester, Massachusetts, United States, 01930
        • Recruiting
        • Addison Gilbert Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 559 978-283-4000
        • Principal Investigator:
          • Brian Labadie
    • Michigan
      • Brownstown, Michigan, United States, 48183
        • Recruiting
        • Henry Ford Cancer Institute-Downriver
        • Principal Investigator:
          • Maria Diab
        • Contact:
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Henry Ford Macomb Hospital-Clinton Township
        • Principal Investigator:
          • Maria Diab
        • Contact:
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Henry Ford Medical Center-Fairlane
        • Principal Investigator:
          • Maria Diab
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Principal Investigator:
          • Maria Diab
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Jackson, Michigan, United States, 49201
        • Recruiting
        • Allegiance Health
        • Principal Investigator:
          • Maria Diab
        • Contact:
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Novi, Michigan, United States, 48377
        • Recruiting
        • Henry Ford Medical Center-Columbus
        • Principal Investigator:
          • Maria Diab
        • Contact:
      • West Bloomfield, Michigan, United States, 48322
        • Recruiting
        • Henry Ford West Bloomfield Hospital
        • Principal Investigator:
          • Maria Diab
        • Contact:
      • Wyandotte, Michigan, United States, 48192
        • Recruiting
        • Henry Ford Wyandotte Hospital
        • Principal Investigator:
          • Maria Diab
        • Contact:
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Gabriel A. Brooks
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Martin R. Weiser
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Martin R. Weiser
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Martin R. Weiser
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Lara McKean Baste
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Steven Nurkin
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Martin R. Weiser
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Martin R. Weiser
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Martin R. Weiser
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Fergal Fleming
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Martin R. Weiser
      • Webster, New York, United States, 14580
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Contact:
        • Principal Investigator:
          • Michael D. Honaker
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Contact:
        • Principal Investigator:
          • Ian M. Paquette
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45409
        • Suspended
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Premier Blood and Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 937-276-8320
        • Principal Investigator:
          • Tarek M. Sabagh
      • Franklin, Ohio, United States, 45005-1066
        • Recruiting
        • Atrium Medical Center-Middletown Regional Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Miami Valley Cancer Care and Infusion
        • Principal Investigator:
          • Tarek M. Sabagh
        • Contact:
          • Site Public Contact
          • Phone Number: 937-569-7515
      • Troy, Ohio, United States, 45373
        • Recruiting
        • Upper Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Contact:
        • Principal Investigator:
          • Ian M. Paquette
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Gresham, Oregon, United States, 97030
        • Recruiting
        • Legacy Mount Hood Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2150
        • Principal Investigator:
          • Mei Dong
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Hagen F. Kennecke
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Good Samaritan Hospital and Medical Center
        • Principal Investigator:
          • Mei Dong
        • Contact:
          • Site Public Contact
          • Phone Number: 800-220-4937
          • Email: cancer@lhs.org
      • Tualatin, Oregon, United States, 97062
        • Recruiting
        • Legacy Meridian Park Hospital
        • Principal Investigator:
          • Mei Dong
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-1742
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Recruiting
        • Christiana Care Health System-Concord Health Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The West Clinic - Wolf River
        • Contact:
        • Principal Investigator:
          • Noam A. VanderWalde
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Cathy Eng
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Tsuyoshi Konishi
      • Temple, Texas, United States, 76508
        • Recruiting
        • Scott and White Memorial Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 254-724-5407
        • Principal Investigator:
          • Lucas Wong
    • Vermont
      • Saint Johnsbury, Vermont, United States, 05819
        • Recruiting
        • Dartmouth Cancer Center - North
        • Contact:
        • Principal Investigator:
          • Gabriel A. Brooks
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • FHCC Overlake
        • Contact:
          • Site Public Contact
          • Phone Number: 425-454-2148
        • Principal Investigator:
          • Nancy Y. Cui
      • Kirkland, Washington, United States, 98034
        • Recruiting
        • FHCC at EvergreenHealth
        • Contact:
          • Site Public Contact
          • Phone Number: 425-899-6000
        • Principal Investigator:
          • Adam Diehl
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Medical Center
        • Principal Investigator:
          • Huong T. Pham
        • Contact:
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Principal Investigator:
          • Stacey A. Cohen
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
      • Seattle, Washington, United States, 98133
        • Recruiting
        • FHCC at Northwest Hospital
        • Principal Investigator:
          • Nikhil V. Kamat
        • Contact:
          • Site Public Contact
          • Phone Number: 206-606-5800
      • Vancouver, Washington, United States, 98686
        • Recruiting
        • Legacy Salmon Creek Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2150
        • Principal Investigator:
          • Mei Dong
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Legacy Cancer Institute Medical Oncology and Day Treatment
        • Principal Investigator:
          • Mei Dong
        • Contact:
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54701
      • Marshfield, Wisconsin, United States, 54449
      • Minocqua, Wisconsin, United States, 54548
      • Rice Lake, Wisconsin, United States, 54868
      • Stevens Point, Wisconsin, United States, 54482
      • Weston, Wisconsin, United States, 54476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.
  • MRI stage cT1 not eligible for transanal surgery or cT2-T3ab*. * T3a: <1mm depth invasion, T3b: 1-5mm depth of invasion.
  • cN0 stage based on pelvic MRI - including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous invasion (EMVI).
  • M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.
  • Mid to low-lying tumour eligible for transanal excision in the opinion of the treating surgeon.
  • Medically fit to undergo radical TME surgery as per treating surgeon's decision.
  • Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French or Spanish.
  • Age of at least 18 years.
  • No contraindications to protocol chemotherapy.
  • Adequate normal organ and marrow function: ANC ≥ x 10^9/L; platelet count ≥ 100 x 10^9/L; bilirubin < 1.5 UNL, excluding Gilbert's syndrome; Estimated creatinine clearance of ≥ 50ml/min
  • Patient must have an ECOG performance of <2 (or Karnofsty ≥ 60%).
  • Must be accessible for treatment and follow-up
  • Males and females of reproductive potential must have agreed to use a highly effective contraceptive method during and for 6 months after completion of chemotherapy.
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

Exclusion Criteria:

  • Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology.
  • Patients with visible pelvic sidewall nodes on MRI.
  • Patients with unequivocal determination of nodal disease that, in the opinion of the investigator, would prohibit protocol therapy administration.
  • Previous pelvic radiation for any reason, including brachytherapy alone.
  • Patients who have had primary lesion excised prior to enrollment. If a patient has had partial excision prior to enrollment, there must be gross residual disease endoscopically for patient to be eligible.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Prior treatment for rectal cancer.
  • Patients with known dihydropyrimidine dehydrogenase deficiency (DYPD).
  • Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
  • Any contra-indications to undergo MRI imaging.
  • Presence of anterior lesions above or near peritoneal reflection rendering the patient ineligible for a transanal tumour excision.
  • T3 tumours invading or abutting the internal sphincter.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FOLFOX OR CAPOX

FOLFOX= Six cycles of modified FOLFOX consisting of leucovorin, oxaliplatin and bolus fluoruracil (optional), infusional fluorouracil.

CAPOX= Capecitabine twice daily for 14 days and Oxaliplatin on day 1
Drug: Leucovorin
400 mg/m2
Drug: Oxaliplatin
85 mg/m2 or 130 mg/m2 on day 1
Drug: Fluoruracil
bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2
Drug: Capecitabine
1,000 mg/m2 twice daily for 14 days
Active Comparator: ChemoRT
Standard dose of infusional 5-Fluorouracil/capecitabine and radiation
Drug: Fluoruracil
bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2
Drug: Capecitabine
1,000 mg/m2 twice daily for 14 days
Radiation: Radiation
54 Gy (27-30 fractions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical response rate upon re-staging
Time Frame: 6 years
6 years
Quality of Life defined using the LARS score
Time Frame: 6 years
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Mesorectal Excision (TME) Free Survival
Time Frame: 6 years
Defined as time from randomization to the time of TME attempt or performance, local recurrence after complete clinical response (cCR), or death from any cause
6 years
Disease Free Survival
Time Frame: 6 years
Defined as time from randomization to local recurrence/regrowth after cCR that cannot be salvaged with an R0 TM, M1 recurrence, or death
6 years
Rate of downstaging to ypTO/1N0/X
Time Frame: 6 years
6 years
Bowel function assessed by Low Anterior Resection Syndrome (LARS) Score
Time Frame: 6 years
6 years
Bladder function assessed by EORTC QLQ-CR29 urinary frequency and urinary incontinence subscales
Time Frame: 6 years
6 years
Other QoL functions assessed by subscales of FIQL
Time Frame: 6 years
6 years
Other QoL functions assessed by subscales of EORTC QLQ-C30
Time Frame: 6 years
6 years
Other QoL functions assessed by subscales of subscales of EORTC QLQ-CR29
Time Frame: 6 years
6 years
Number and severity of adverse events utilizing CTCAE v5.0
Time Frame: 6 years
6 years
Overall Survival
Time Frame: 6 years
Among patients treated with induction chemotherapy versus chemoradiotherapy
6 years
Validate the magnetic resonance tumour regression grade (MR-TRG) in patients with T1-T3a rectal cancer
Time Frame: 6 years
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Cancer Trials Group

Collaborators

Alliance for Clinical Trials in Oncology
NRG Oncology
ECOG-ACRIN Cancer Research Group
SWOG Cancer Research Network

Investigators

  • Study Chair: Hagen Kennecke, Providence Portland Medical Centre, Portland, OR, USA
  • Study Chair: Carl Brown, St. Paul's Hospital, Vancouver, BC, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2024

Primary Completion (Estimated)

January 30, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTG-CO32 (Other Identifier: NCI/CTEP)
  • NCI-2023-10515 (Other Identifier: NCI CTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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