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Clinical Trials in Canada / NCT06205485
Recruiting Phase 3

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

NCT06205485 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2024-06-26
Last updated
2026-07-14

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Leucovorin →Oxaliplatin →FluoruracilCapecitabine →Radiation

Leucovorin: 400 mg/m2

Oxaliplatin: 85 mg/m2 or 130 mg/m2 on day 1

Fluoruracil: bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2

Capecitabine: 1,000 mg/m2 twice daily for 14 days

Radiation: 54 Gy (27-30 fractions)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (113)

FacilityCityRegionStatus
Cancer Center at Saint Joseph's Phoenix Arizona Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California Recruiting
Los Angeles General Medical Center Los Angeles California Recruiting
USC / Norris Comprehensive Cancer Center Los Angeles California Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California Recruiting
Mission Hope Medical Oncology - Santa Maria Santa Maria California Recruiting
Beebe South Coastal Health Campus Millville Delaware Recruiting
Helen F Graham Cancer Center Newark Delaware Recruiting
Medical Oncology Hematology Consultants PA Newark Delaware Recruiting
Beebe Health Campus Rehoboth Beach Delaware Recruiting
Orlando Health Cancer Institute Orlando Florida Suspended
Emory University Hospital Midtown Atlanta Georgia Recruiting
Emory University Hospital/Winship Cancer Institute Atlanta Georgia Recruiting
Emory Saint Joseph's Hospital Atlanta Georgia Recruiting
Rush-Copley Medical Center Aurora Illinois Recruiting
Northwestern University Chicago Illinois Recruiting
Carle at The Riverfront Danville Illinois Recruiting
Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois Recruiting
Carle Physician Group-Effingham Effingham Illinois Recruiting
Northwestern Medicine Cancer Center Delnor Geneva Illinois Recruiting
Carle Physician Group-Mattoon/Charleston Mattoon Illinois Recruiting
Carle Cancer Center Urbana Illinois Recruiting
Northwestern Medicine Cancer Center Warrenville Warrenville Illinois Recruiting
Northwest Cancer Center - Crown Point Crown Point Indiana Recruiting
Northwest Oncology LLC Dyer Indiana Recruiting
Northwest Cancer Center - Hobart Hobart Indiana Recruiting
Saint Mary Medical Center Hobart Indiana Recruiting
The Community Hospital Munster Indiana Recruiting
Northwest Cancer Center - Valparaiso Valparaiso Indiana Recruiting
Ochsner Hematology Oncology North Shore - Covington (West Region) Covington Louisiana Recruiting
University Medical Center New Orleans New Orleans Louisiana Recruiting
Ochsner Medical Center Jefferson New Orleans Louisiana Recruiting
Beverly Hospital Beverly Massachusetts Recruiting
Lahey Clinic Burlington Massachusetts Recruiting
Addison Gilbert Hospital Gloucester Massachusetts Recruiting
Henry Ford Cancer Institute-Downriver Brownstown Michigan Recruiting
Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan Recruiting
Henry Ford Medical Center-Fairlane Dearborn Michigan Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan Recruiting

+ 73 more sites — see the full list on the official registry below.

More Canadian Cancer Trials Group trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06205485 on ClinicalTrials.gov ↗ ← All trials in Canada