Comparing Leucovorin with Radiation for rectal cancer
Official title: Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer
Interventions
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)
Canadian Sites (8)
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Eligibility Criteria
See who this study is looking for27 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- +Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.
- +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.
- +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.
- +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-upFollow-upContinued check-ins after the treatment part is finished.Read more →
- +MRI stage cT1 not eligible for transanal surgery or cT2-T3ab\*. \* T3a: \<1mm depth invasion, T3b: 1-5mm depth of invasion.
- +Medically fit to undergo radical TME surgery as per treating surgeon's decision.
- +No contraindications to protocolProtocolThe detailed plan a study must follow.Read more → chemotherapy.
- +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.
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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would prohibit protocolProtocolThe detailed plan a study must follow.Read more → therapy administration.
- −Patients who have had primary lesion excised prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →. 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 eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → 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.
- −Previous pelvic radiation for any reason, including brachytherapy alone.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Leucovorin, Oxaliplatin, Fluoruracil, Capecitabine, and 1 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 250 people.
The study is currently expected to finish around June 2030.
The main measurement is taken over: 6 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Clinical response rate upon re-staging — measured over 6 years.
Quality of Life defined using the LARS score — measured over 6 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06205485 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About LeucovorinDrug
400 mg/m2
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About OxaliplatinDrug
85 mg/m2 or 130 mg/m2 on day 1
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About FluoruracilDrug
bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CapecitabineDrug
1,000 mg/m2 twice daily for 14 days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About RadiationRadiation
54 Gy (27-30 fractions)
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 6 years.
The study as a whole is currently expected to finish around 2030-06-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 250 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 30 locations, including: Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; St. John's, Newfoundland and Labrador, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada; Montreal, Quebec, Canada, and 24 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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?
Other Sites (25)
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Wilmot Cancer Institute at Webster
Webster, New York, United States
FHCC Overlake
Bellevue, Washington, United States
FHCC at EvergreenHealth
Kirkland, Washington, United States
And 5 more sites worldwide.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.