Recruiting nowPhase 3Randomised
What this trial is trying to do
The trial asks whether starting with triplet chemotherapy (FOLFOXIRI) before chemoradiotherapy can eliminate more of a high-risk, locally advanced rectal cancer than the usual two-drug induction chemotherapy (CAPOX or FOLFOX). Patients with a complete response may follow surgery or a watch-and-wait pathway rather than automatically having an operation.
The researchers expect the extra drug in FOLFOXIRI could increase complete responses—meaning no remaining detectable tumour on assessment—and may improve quality of life and longer-term cancer outcomes compared with doublet chemotherapy. The comparison will measure complete response as the main outcome, while also considering quality of life and cancer control, against an anticipated increase in treatment toxicity.
Worth knowing: This applies to a relatively narrow group with high-risk locally advanced rectal cancer, and the main outcome is complete response rather than survival itself; FOLFOXIRI is expected to cause more toxicity.
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 | NCT07472868 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 394 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | J. W. A. Burger |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug FOLFOXIRI
- Drug CAPOX
- Drug FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- Radiotherapy Chemoradiotherapy
- Procedure Total mesorectal excision (+/- IORT)
- Test Watch-and-wait approach
What it is measuring
Complete response
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
The aim of this clinical trial is to compare triplet induction therapy (FOLFOXIRI) with doublet induction therapy (CAPOX/FOLFOX), followed by chemoradiotherapy and either surgery or a watch-and-wait approach, in patients with high-risk locally advanced rectal cancer. The primary questions it seeks to address are whether triplet induction therapy results in higher complete response rates, improved quality of life, and better long-term oncological outcomes compared to doublet induction therapy, despite the anticipated increased risk of toxicity.
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
- 18 years or older
- WHO performance score 0-1.
- Fit for (modified dose) triple chemotherapy (FOLFOXIRI)
- Histopathological confirmed rectal cancer. (Lower border of the tumour located on or below the sigmoidal take-off as established on MRI of the pelvis.)
- Confirmed high-risk locally advanced rectal cancer, at high risk of treatment failure, meeting one of the following imaging-based criteria:
- cT4b-tumour or evident tumour invasion of the MRF: distance to MRF 0 mm AND thickening of the MRF over a length of approximately 5 mm (MRF ≤ 1 mm is not considered sufficient).
- The presence of grade 4 extramural venous invasion (mrEMVI)
- The presence of tumour deposits (TD)
- The presence of bilateral extramesorectal lymph nodes with a short-axis size ≥ 7mm (LLN) or extensive LLN involving pelvic side wall structures, at high risk of an incomplete resection.
- Resectable disease as determined on magnetic resonance imaging (MRI) or deemed resectable disease after neoadjuvant treatment.
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 20 sites. Listed in: Netherlands.
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 NCT07472868, registered by J. W. A. Burger 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.