Recruiting nowPhase 3Randomised
| Registry number | NCT06205485 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 250 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Canadian Cancer Trials Group |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Leucovorin
- Drug Oxaliplatin
- Drug Fluoruracil
- Drug Capecitabine
- Radiotherapy Radiation
What it is measuring
Clinical response rate upon re-staging
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
The trial asks whether chemotherapy before limited surgery can control rectal cancer as well as combined chemotherapy and radiation before surgery. The chemotherapy drugs damage cancer cells, while radiation adds local treatment to the tumour and surrounding rectum.
If chemotherapy alone gives a similar clinical response when the cancer is reassessed, omitting radiation could reduce treatment burden and improve quality of life. The main comparison is the response rate at restaging, rather than how long people live.
Worth knowing: Response at restaging is an early measure and does not by itself show that either approach improves survival or long-term bowel function.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
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?
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 113 sites. Listed in: Canada, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06205485, registered by Canadian Cancer Trials Group on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.