Actively Recruiting
Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
Led by Canadian Cancer Trials Group · Updated on 2026-05-12
250
Participants Needed
107
Research Sites
313 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
A
Alliance for Clinical Trials in Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 without mesorectal nodal metastasis, tumour deposits, or extramural venous invasion.
- M0 stage with no metastatic disease on CT imaging of chest, abdomen, and pelvis.
- Mid to low-lying tumour suitable for transanal excision per surgeon's opinion.
- Medically fit for radical TME surgery as decided by treating surgeon.
- Able and willing to complete quality of life questionnaires in English, French, or Spanish.
- At least 18 years old.
- No contraindications to protocol chemotherapy.
- Adequate organ and marrow function (ANC ≥ x 10^9/L; platelets ≥ 100 x 10^9/L; bilirubin < 1.5 UNL excluding Gilbert's syndrome; creatinine clearance ≥ 50 ml/min).
- ECOG performance status <2 or Karnofsky ≥ 60%.
- Accessible for treatment and follow-up.
- Agree to use highly effective contraception during and for 6 months after chemotherapy if of reproductive potential.
- HIV-infected patients on effective therapy with undetectable viral load within 6 months are eligible.
You will not qualify if you...
- High-risk pathology on biopsy: poorly differentiated, mucinous, or signet ring cell histology.
- Visible pelvic sidewall lymph nodes on MRI.
- Confirmed nodal disease that prevents protocol therapy.
- Previous pelvic radiation, including brachytherapy alone.
- Prior excision of primary lesion before enrollment unless gross residual disease remains.
- Prior treatment for rectal cancer.
- Known deficiency of dihydropyrimidine dehydrogenase (DYPD).
- Not fully recovered from adverse events of recent therapies.
- History or symptoms of cardiac disease requiring assessment; must be NYHA class 2B or better.
- Contraindications to MRI imaging.
- Tumours above or near peritoneal reflection making transanal excision unsuitable.
- T3 tumours invading or touching the internal sphincter.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 107 locations
1
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States, 85004
Actively Recruiting
2
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
3
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
5
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
6
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States, 93444
Actively Recruiting
7
Beebe South Coastal Health Campus
Millville, Delaware, United States, 19967
Actively Recruiting
8
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Actively Recruiting
9
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Actively Recruiting
10
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
Actively Recruiting
11
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Actively Recruiting
12
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
13
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
14
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
15
Rush-Copley Medical Center
Aurora, Illinois, United States, 60504
Actively Recruiting
16
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
17
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
18
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
19
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
20
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
21
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
22
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
23
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
24
Northwest Cancer Center - Crown Point
Crown Point, Indiana, United States, 46307
Actively Recruiting
25
Northwest Oncology LLC
Dyer, Indiana, United States, 46311
Actively Recruiting
26
Northwest Cancer Center - Hobart
Hobart, Indiana, United States, 46342
Actively Recruiting
27
Saint Mary Medical Center
Hobart, Indiana, United States, 46342
Actively Recruiting
28
The Community Hospital
Munster, Indiana, United States, 46321
Actively Recruiting
29
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, United States, 46383
Actively Recruiting
30
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
31
Beverly Hospital
Beverly, Massachusetts, United States, 01915
Actively Recruiting
32
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
33
Addison Gilbert Hospital
Gloucester, Massachusetts, United States, 01930
Actively Recruiting
34
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, United States, 48183
Actively Recruiting
35
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States, 48038
Actively Recruiting
36
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States, 48126
Actively Recruiting
37
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
38
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
39
Allegiance Health
Jackson, Michigan, United States, 49201
Actively Recruiting
40
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
41
Henry Ford Medical Center-Columbus
Novi, Michigan, United States, 48377
Actively Recruiting
42
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
Actively Recruiting
43
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, United States, 48192
Actively Recruiting
44
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Actively Recruiting
45
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
46
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
47
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
48
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
49
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
50
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
51
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
52
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
53
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
54
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
55
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
56
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
57
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
58
Wilmot Cancer Institute at Webster
Webster, New York, United States, 14580
Actively Recruiting
59
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
60
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Actively Recruiting
61
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
62
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
63
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Actively Recruiting
64
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
65
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Suspended
66
Premier Blood and Cancer Center
Dayton, Ohio, United States, 45409
Actively Recruiting
67
Miami Valley Hospital North
Dayton, Ohio, United States, 45415
Actively Recruiting
68
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Actively Recruiting
69
Miami Valley Cancer Care and Infusion
Greenville, Ohio, United States, 45331
Actively Recruiting
70
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Actively Recruiting
71
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
72
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Actively Recruiting
73
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Actively Recruiting
74
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Actively Recruiting
75
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Actively Recruiting
76
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Actively Recruiting
77
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
78
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
79
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
80
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
Actively Recruiting
81
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States, 19317
Actively Recruiting
82
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
83
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
84
The West Clinic - Wolf River
Germantown, Tennessee, United States, 38138
Actively Recruiting
85
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
86
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
87
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
Actively Recruiting
88
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, United States, 05819
Actively Recruiting
89
FHCC Overlake
Bellevue, Washington, United States, 98004
Actively Recruiting
90
FHCC at EvergreenHealth
Kirkland, Washington, United States, 98034
Actively Recruiting
91
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
92
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
93
FHCC at Northwest Hospital
Seattle, Washington, United States, 98133
Actively Recruiting
94
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, United States, 98684
Actively Recruiting
95
Legacy Salmon Creek Hospital
Vancouver, Washington, United States, 98686
Actively Recruiting
96
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
97
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
98
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States, 54548
Actively Recruiting
99
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States, 54868
Actively Recruiting
100
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States, 54482
Actively Recruiting
101
Marshfield Medical Center - Weston
Weston, Wisconsin, United States, 54476
Actively Recruiting
102
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
103
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
104
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
105
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
106
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Actively Recruiting
107
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Actively Recruiting
Research Team
C
Chris O'Callaghan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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