Rectal CancerPhase 3NEO-RTNCT06205485
Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
A Phase 3 study testing Leucovorin, Oxaliplatin and Fluoruracil in people with Rectal Cancer, run by Canadian Cancer Trials Group at 113 sites in 2 countries.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Leucovorin, Oxaliplatin and Fluoruracil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 113 sitesin 2 countries
- Study dates
- 26 Jun 2024to 30 Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
113 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
113 sites in 2 countries
United States105 sites, 103 recruiting
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Lara McKean Baste
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Patrick S. Sullivan
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Patrick S. Sullivan
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Patrick S. Sullivan
- Recruiting
Rush-Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu
Prem Sobti
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
Martin R. Weiser
- Recruiting
FHCC Overlake
Bellevue, Washington, 98004
Site Public Contact, 425-454-2148
Nancy Y. Cui
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Beverly Hospital
Beverly, Massachusetts, 01915
Site Public Contact, 978-922-3000 ext. 2405
Brian Labadie
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Maria Diab
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Steven Nurkin
- Recruiting
Lahey Clinic
Burlington, Massachusetts, 01805
Site Public Contact, 781-744-3421, lhmc-cancer-clinical-trials@lahey.org
Brian Labadie
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Aparna Kalyan
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Ian M. Paquette
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Dan S. Zuckerman
- Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Maria Diab
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Philip S. Bauer
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
Martin R. Weiser
- Recruiting
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana, 70433
Site Public Contact, 985-809-5668, Cheryl.kesler@ochsner.org
Jonathan D. Mizrahi
- Recruiting
Northwest Cancer Center - Crown Point
Crown Point, Indiana, 46307
Site Public Contact, 219-836-6879, CancerResearch@powershealth.org
Prem Sobti
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Prem Sobti
- Suspended
Miami Valley Hospital
Dayton, Ohio, 45409
- Recruiting
Premier Blood and Cancer Center
Dayton, Ohio, 45409
Site Public Contact, 937-276-8320
Tarek M. Sabagh
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Maria Diab
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Aparna Kalyan
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Maria Diab
- Recruiting
Northwest Oncology LLC
Dyer, Indiana, 46311
Site Public Contact, 219-924-8178
Prem Sobti
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Rohit Sharma
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Aparna Kalyan
- Recruiting
The West Clinic - Wolf River
Germantown, Tennessee, 38138
Site Public Contact, 901-683-0055, afletcher@westclinic.com
Noam A. VanderWalde
- Recruiting
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930
Site Public Contact, 978-283-4000 ext. 559
Brian Labadie
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Site Public Contact, 252-744-1015, eubankss@ecu.edu
Michael D. Honaker
- Recruiting
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Site Public Contact, 937-569-7515
Tarek M. Sabagh
- Recruiting
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030
Site Public Contact, 503-413-2150
Mei Dong
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
Martin R. Weiser
- Recruiting
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Site Public Contact, 717-531-3779, CTO@hmc.psu.edu
Nelson S. Yee
- Recruiting
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342
Site Public Contact, 219-947-1795
Prem Sobti
- Recruiting
Saint Mary Medical Center
Hobart, Indiana, 46342
Site Public Contact, 219-836-6875, CancerResearch@COMHS.org
Prem Sobti
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org
Tsuyoshi Konishi
- Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Jason A. Zell
- Recruiting
Allegiance Health
Jackson, Michigan, 49201
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Maria Diab
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
FHCC at EvergreenHealth
Kirkland, Washington, 98034
Site Public Contact, 425-899-6000
Adam Diehl
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Gabriel A. Brooks
- Recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451, uscnorrisinfo@med.usc.edu
Joshua P. Schiff
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
Joshua P. Schiff
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Rohit Sharma
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Site Public Contact, 212-639-7592
Martin R. Weiser
- Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Rohit Sharma
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Site Public Contact, 212-639-7592
Martin R. Weiser
- Recruiting
The Community Hospital
Munster, Indiana, 46321
Site Public Contact, 219-836-3349
Prem Sobti
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Site Public Contact, 800-811-8480
Cathy Eng
- Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Sanda A. Tan
- Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org
Jonathan D. Mizrahi
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Site Public Contact, 212-639-7592
Martin R. Weiser
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Dan S. Zuckerman
- Recruiting
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Maria Diab
- Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Jason A. Zell
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Suspended
Orlando Health Cancer Institute
Orlando, Florida, 32806
- Recruiting
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
Site Public Contact, 800-220-4937, cancer@lhs.org
Mei Dong
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Dan S. Zuckerman
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Dan S. Zuckerman
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Site Public Contact, 503-494-1080, trials@ohsu.edu
Hagen F. Kennecke
- Recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Rohit Sharma
- Recruiting
University of Rochester
Rochester, New York, 14642
Site Public Contact, 585-275-5830
Fergal Fleming
- Recruiting
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
Site Public Contact, 800-639-6918, cancer.research.nurse@hitchcock.org
Gabriel A. Brooks
- Recruiting
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
Site Public Contact, 206-287-6275, cancerresearch@virginiamason.org
Huong T. Pham
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Stacey A. Cohen
- Recruiting
FHCC at Northwest Hospital
Seattle, Washington, 98133
Site Public Contact, 206-606-5800
Nikhil V. Kamat
- Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org
Daniel Almquist
- Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Site Public Contact, 314-251-7066
Jay W. Carlson
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Rohit Sharma
- Recruiting
Scott and White Memorial Hospital
Temple, Texas, 76508
Site Public Contact, 254-724-5407
Lucas Wong
- Recruiting
Upper Valley Medical Center
Troy, Ohio, 45373
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062
Site Public Contact, 503-413-1742
Mei Dong
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Site Public Contact, 212-639-7592
Martin R. Weiser
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383
Site Public Contact, 219-836-6875, CancerResearch@COMHS.org
Prem Sobti
- Recruiting
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, 98684
Site Public Contact, oncologyresearch@lhs.org
Mei Dong
- Recruiting
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686
Site Public Contact, 503-413-2150
Mei Dong
- Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Aparna Kalyan
- Recruiting
Wilmot Cancer Institute at Webster
Webster, New York, 14580
Site Public Contact, WCICTOresearch@urmc.rochester.edu
Fergal Fleming
- Recruiting
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Maria Diab
- Recruiting
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
Site Public Contact, 513-584-7698, cancer@uchealth.com
Ian M. Paquette
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Rohit Sharma
- Recruiting
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, 48192
Site Public Contact, nhay@hfhs.org
Maria Diab
Canada8 sites, 8 recruiting
- Recruiting
London Regional Cancer Program
London, Ontario, N6A 4L6
Site Public Contact, 519-685-8600
Terry M. Zwiep
- Recruiting
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Site Public Contact, 514-252-3400 ext. 3329
Mikael Soucisse
- Recruiting
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6
Site Public Contact, 613-761-4395
Kristopher Dennis
- Recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Site Public Contact, 306-766-2213
Mussawar Iqbal
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Site Public Contact, 306-655-2914
Shahid Ahmed
- Recruiting
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Site Public Contact, 709-777-7589
Teri L. Stuckless
- Recruiting
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Site Public Contact, 888-939-3333
Jonathan M. Loree
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Site Public Contact, 866-561-1026, ctu_web@cancercare.mb.ca
Eric Hyun
About this study
Official title: 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?
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Leucovorin, Oxaliplatin, Fluoruracil, Capecitabine, Radiation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucovorinDrug
400 mg/m2
OxaliplatinDrug
85 mg/m2 or 130 mg/m2 on day 1
FluoruracilDrug
bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2
CapecitabineDrug
1,000 mg/m2 twice daily for 14 days
RadiationRadiation
54 Gy (27-30 fractions)
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX OR CAPOX | Active comparator | 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 Receives: Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluoruracil; Drug: Capecitabine |
| ChemoRT | Active comparator | Standard dose of infusional 5-Fluorouracil/capecitabine and radiation Receives: Drug: Fluoruracil; Drug: Capecitabine; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate upon re-staging
Measured: 6 years
Quality of Life defined using the LARS score
Measured: 6 years
Secondary outcomes (11)
Total Mesorectal Excision (TME) Free Survival
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
Measured: 6 years
Disease Free Survival
Defined as time from randomization to local recurrence/regrowth after cCR that cannot be salvaged with an R0 TM, M1 recurrence, or death
Measured: 6 years
Overall Survival
Among patients treated with induction chemotherapy versus chemoradiotherapy
Measured: 6 years
Rate of downstaging to ypTO/1N0/X
Measured: 6 years
Bowel function assessed by Low Anterior Resection Syndrome (LARS) Score
Measured: 6 years
Bladder function assessed by EORTC QLQ-CR29 urinary frequency and urinary incontinence subscales
Measured: 6 years
Other QoL functions assessed by subscales of FIQL
Measured: 6 years
Other QoL functions assessed by subscales of EORTC QLQ-C30
Measured: 6 years
Other QoL functions assessed by subscales of subscales of EORTC QLQ-CR29
Measured: 6 years
Number and severity of adverse events utilizing CTCAE v5.0
Measured: 6 years
Validate the magnetic resonance tumour regression grade (MR-TRG) in patients with T1-T3a rectal cancer
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start26 Jun 2024
- Primary completion30 Jan 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, SWOG Cancer Research Network
- Responsible party
- Sponsor
- Investigators
- Hagen Kennecke, Study chair, Providence Portland Medical Centre, Portland, OR, USACarl Brown, Study chair, St. Paul's Hospital, Vancouver, BC, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205485
- Sponsor's protocol ID
- CCTG-CO32
- Other IDs
- CCTG-CO32, NCI-2023-10515
- Acronym
- NEO-RT
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer
- ClinicalTrials.gov ID
- NCT06205485
- Acronym / sponsor ID
- NEO-RT / CCTG-CO32
- Conditions
- Rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, SWOG Cancer Research Network
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 30 Jan 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOX OR CAPOX | Active comparator | Drug: Leucovorin, Drug: Oxaliplatin, Drug: Fluoruracil, Drug: CapecitabineFOLFOX= 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 |
| ChemoRT | Active comparator | Drug: Fluoruracil, Drug: Capecitabine, Radiation: RadiationStandard dose of infusional 5-Fluorouracil/capecitabine and radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leucovorin400 mg/m2 | Drug | FOLFOX OR CAPOX |
| Oxaliplatin85 mg/m2 or 130 mg/m2 on day 1 | Drug | FOLFOX OR CAPOX |
| Fluoruracilbolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2 | Drug | ChemoRT, FOLFOX OR CAPOX |
| Capecitabine1,000 mg/m2 twice daily for 14 days | Drug | ChemoRT, FOLFOX OR CAPOX |
| Radiation54 Gy (27-30 fractions) | Radiation | ChemoRT |
Primary outcome
Clinical response rate upon re-staging
Time frame: 6 years
Quality of Life defined using the LARS score
Time frame: 6 years
11 secondary outcomes
Total Mesorectal Excision (TME) Free Survival
Time frame: 6 years
Disease Free Survival
Time frame: 6 years
Overall Survival
Time frame: 6 years
Rate of downstaging to ypTO/1N0/X
Time frame: 6 years
Bowel function assessed by Low Anterior Resection Syndrome (LARS) Score
Time frame: 6 years
Bladder function assessed by EORTC QLQ-CR29 urinary frequency and urinary incontinence subscales
Time frame: 6 years
Other QoL functions assessed by subscales of FIQL
Time frame: 6 years
Other QoL functions assessed by subscales of EORTC QLQ-C30
Time frame: 6 years
Other QoL functions assessed by subscales of subscales of EORTC QLQ-CR29
Time frame: 6 years
Number and severity of adverse events utilizing CTCAE v5.0
Time frame: 6 years
Validate the magnetic resonance tumour regression grade (MR-TRG) in patients with T1-T3a rectal cancer
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hagen Kennecke study chair
Providence Portland Medical Centre, Portland, OR, USA
Carl Brown study chair
St. Paul's Hospital, Vancouver, BC, Canada
113 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leucovorin, Oxaliplatin and Fluoruracil in people with Rectal Cancer, run by Canadian Cancer Trials Group at 113 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris O'Callaghan (613-533-6430, cocallaghan@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate upon re-staging (time frame: 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.