Recruiting nowPhase 3Randomised
What this trial is trying to do
The researchers expect that early tumour shrinkage on MRI after short, intensive induction chemotherapy with modified FOLFIRINOX can identify people with a particularly treatment-sensitive rectal cancer. In those with a very good response, the trial tests whether immediate surgery can replace the usual radiochemotherapy followed by surgery, while less responsive tumours receive management based on their poorer response.
The idea is that some very good responders may not need radiochemotherapy, potentially reducing treatment-related bowel and sexual problems while still allowing complete tumour removal. The main comparison is whether immediate surgery achieves an R0 resection—removal with no cancer at the surgical margin—as often as radiochemotherapy followed by surgery.
Worth knowing: The main outcome is a surgical measure rather than survival, and the randomised comparison applies specifically to people who show a very good early MRI response.
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.
| Registry number | NCT04749108 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 1,075 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Institut du Cancer de Montpellier – Val d'Aurelle |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Induction chemotherapy – modified FOLFIRINOX regimen
- Other Early tumor response evaluation by MRI volumetry
- Radiotherapy Radiochemotherapy Cap 50
- Procedure Radical proctectomy with total mesorectal excision
What it is measuring
R0 resection rate (R0 is defined as Circumferential resection margin (CRM ≥ 1 mm) for Phase II
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.
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
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response.
The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders.
"Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
- Rectal
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 FOR SCREENING
1. Written consent,
2. Patient who receive Folfirinox,
3. Patient aged over 18 years old,
4. World Health Organization (WHO) performance status ≥ 1,
5. Histologically confirmed diagnosis of adenocarcinoma of the rectum,
6. Distal part of the tumor from 1 to 12 cm from the upper part of the levator ani (dynamic rectal examination),
7. No unequivocal evidence on CT-Scan of established metastatic disease,
8. MRI evaluation of the locally advanced tumor before neoadjuvant chemotherapy:
1. Predictive CRM < 2 mm
2. Or T3c-d (extending ≥ 5 mm beyond the muscularis propria) with extra mural venous invasion (EMVI)
3. Or T4a-b (except bone and sphincteric invasion).
NON INCLUSION CRITERIA FOR SCREENING
1. Non measurable rectal tumor or not assessed by MRI before inclusion,
2. Ultra-low rectal tumor at diagnosis which imposes radiotherapy administration (inferior tumor pole less than 1 cm from the upper part of the levator ani).
3. Active cardiac disease including any of the following: a. Congestive heart failure ≥ New York Heart Association (NYHA) class 2 (appendix 4), b. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), c. Myocardial infarction less than 6 months before first dose of treatment, d. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted),
4.
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 30 sites. Listed in: France.
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 NCT04749108, registered by Institut du Cancer de Montpellier – Val d'Aurelle 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.