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

Status: Recruiting
Location: See all (92) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.

• MRI stage cT1 not eligible for transanal surgery or cT2-T3a.

• 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.

Locations
United States
Arizona
Cancer Center at Saint Joseph's
RECRUITING
Phoenix
California
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITING
Irvine
Los Angeles General Medical Center
RECRUITING
Los Angeles
USC / Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
UC Irvine Health/Chao Family Comprehensive Cancer Center
RECRUITING
Orange
Delaware
Beebe South Coastal Health Campus
RECRUITING
Millville
Helen F Graham Cancer Center
RECRUITING
Newark
Medical Oncology Hematology Consultants PA
RECRUITING
Newark
Beebe Health Campus
RECRUITING
Rehoboth Beach
Georgia
Emory Saint Joseph's Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Illinois
Rush-Copley Medical Center
RECRUITING
Aurora
Northwestern University
RECRUITING
Chicago
Carle at The Riverfront
RECRUITING
Danville
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING
Dekalb
Carle Physician Group-Effingham
RECRUITING
Effingham
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
Carle Cancer Center
RECRUITING
Urbana
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Indiana
Northwest Cancer Center - Main Campus
RECRUITING
Crown Point
Northwest Oncology LLC
RECRUITING
Dyer
Northwest Cancer Center - Hobart
RECRUITING
Hobart
Saint Mary Medical Center
RECRUITING
Hobart
The Community Hospital
RECRUITING
Munster
Northwest Cancer Center - Valparaiso
RECRUITING
Valparaiso
Louisiana
University Medical Center New Orleans
RECRUITING
New Orleans
Massachusetts
Lahey Hospital and Medical Center
RECRUITING
Burlington
Michigan
Henry Ford Macomb Hospital-Clinton Township
RECRUITING
Clinton Township
Henry Ford Hospital
RECRUITING
Detroit
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITING
Grand Rapids
Allegiance Health
RECRUITING
Jackson
West Michigan Cancer Center
RECRUITING
Kalamazoo
Henry Ford Medical Center-Columbus
RECRUITING
Novi
Henry Ford West Bloomfield Hospital
RECRUITING
West Bloomfield
Minnesota
Sanford Joe Lueken Cancer Center
RECRUITING
Bemidji
Missouri
Mercy Hospital Saint Louis
RECRUITING
St Louis
North Carolina
East Carolina University
RECRUITING
Greenville
North Dakota
Sanford Bismarck Medical Center
RECRUITING
Bismarck
Sanford Broadway Medical Center
RECRUITING
Fargo
Sanford Roger Maris Cancer Center
RECRUITING
Fargo
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
New Jersey
Memorial Sloan Kettering Basking Ridge
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth
RECRUITING
Middletown
Memorial Sloan Kettering Bergen
RECRUITING
Montvale
New Mexico
University of New Mexico Cancer Center
RECRUITING
Albuquerque
Nevada
Renown Regional Medical Center
RECRUITING
Reno
New York
Memorial Sloan Kettering Commack
RECRUITING
Commack
Memorial Sloan Kettering Westchester
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Memorial Sloan Kettering Nassau
RECRUITING
Uniondale
Wilmot Cancer Institute at Webster
RECRUITING
Webster
Ohio
Miami Valley Hospital South
RECRUITING
Centerville
University of Cincinnati Cancer Center-UC Medical Center
RECRUITING
Cincinnati
Miami Valley Hospital
SUSPENDED
Dayton
Miami Valley Hospital North
RECRUITING
Dayton
Premier Blood and Cancer Center
RECRUITING
Dayton
Atrium Medical Center-Middletown Regional Hospital
RECRUITING
Franklin
Miami Valley Cancer Care and Infusion
RECRUITING
Greenville
Upper Valley Medical Center
RECRUITING
Troy
University of Cincinnati Cancer Center-West Chester
RECRUITING
West Chester
Oregon
Clackamas Radiation Oncology Center
RECRUITING
Clackamas
Legacy Mount Hood Medical Center
RECRUITING
Gresham
Providence Newberg Medical Center
RECRUITING
Newberg
Providence Willamette Falls Medical Center
RECRUITING
Oregon City
Legacy Good Samaritan Hospital and Medical Center
RECRUITING
Portland
Oregon Health and Science University
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Legacy Meridian Park Hospital
RECRUITING
Tualatin
Pennsylvania
Christiana Care Health System-Concord Health Center
RECRUITING
Chadds Ford
South Dakota
Sanford Cancer Center Oncology Clinic
RECRUITING
Sioux Falls
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
The West Clinic - Wolf River
RECRUITING
Germantown
Vanderbilt University/Ingram Cancer Center
RECRUITING
Nashville
Vermont
Dartmouth Cancer Center - North
RECRUITING
Saint Johnsbury
Washington
Virginia Mason Medical Center
RECRUITING
Seattle
Legacy Cancer Institute Medical Oncology and Day Treatment
RECRUITING
Vancouver
Legacy Salmon Creek Hospital
RECRUITING
Vancouver
Wisconsin
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
Marshfield Medical Center-Rice Lake
RECRUITING
Rice Lake
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Marshfield Medical Center - Weston
RECRUITING
Weston
Other Locations
Canada
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
RECRUITING
Montreal
Ottawa Hospital and Cancer Center-General Campus
RECRUITING
Ottawa
Allan Blair Cancer Centre
RECRUITING
Regina
Saskatoon Cancer Centre
RECRUITING
Saskatoon
CancerCare Manitoba
RECRUITING
Winnipeg
Contact Information
Primary
Chris O'Callaghan
cocallaghan@ctg.queensu.ca
613-533-6430
Time Frame
Start Date: 2024-06-26
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 250
Treatments
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
Active_comparator: ChemoRT
Standard dose of infusional 5-Fluorouracil/capecitabine and radiation
Related Therapeutic Areas
Sponsors
Collaborators: Alliance for Clinical Trials in Oncology, SWOG Cancer Research Network, ECOG-ACRIN Cancer Research Group, NRG Oncology
Leads: Canadian Cancer Trials Group

This content was sourced from clinicaltrials.gov