Rectal Cancer Study: Chemotherapy Alone vs. Chemotherapy with Radiation
This study is for people with early-stage rectal cancer (rectal adenocarcinoma) that has not spread. It compares two approaches: either chemotherapy alone (using drugs like Leucovorin, Oxaliplatin, Fluorouracil, or Capecitabine) or chemotherapy combined with radiation therapy, both given before surgery. The main goal is to see if chemotherapy alone works as well as chemotherapy plus radiation in shrinking the cancer, and if it leads to a better quality of life. You may be able to join if you are 18 or older and have specific types of rectal cancer confirmed by a biopsy (histologically confirmed) and MRI scans. The study aims to enroll 250 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 250 participants to compare two treatment approaches for rectal cancer.
- What's involved
- You would receive either chemotherapy for up to 12 weeks or chemotherapy with radiation for up to 6 weeks, followed by surgery. After surgery, you would have follow-up visits for up to 5 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 5 years after surgery, with clinical response and quality of life measured at 6 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06205485
Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
Recruiting
PHASE3Ages 18+InterventionalTreatmentCanadian Cancer Trials GroupGovernment-funded
~250 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:LeucovorinOxaliplatinFluoruracilCapecitabineRadiation
At a glance
Recruiting sites
111 of 113 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical response rate upon re-staging
Measured over 6 years
+1 more outcome measured
Conditions
Where it's being run
113 sites across 34 statesMichigan10
Ohio10
Illinois9
Oregon9
New York7
Washington7
Indiana6
Wisconsin6
Study leadership
- Hagen Kennecke · STUDY_CHAIR · Providence Portland Medical Centre, Portland, OR, USA
- Carl Brown · STUDY_CHAIR · St. Paul's Hospital, Vancouver, BC, Canada
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Clinical response rate upon re-staging6 years
- Quality of Life defined using the LARS score6 years