Recruiting nowPhase 2
| Registry number | NCT05845450 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 197 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Gruppo Oncologico del Nord-Ovest |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Trastuzumab deruxtecan
- Drug Durvalumab
- Drug Panitumumab
- Drug Botensilimab
- Drug Balstilimab
- Drug Sotorasib
- Drug Vorbipiprant
- Drug Nivolumab
- Drug Amivantamab
What it is measuring
major pathological response rate
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 researchers expect that matching a targeted drug or immune treatment to a tumour’s molecular alteration could shrink or damage a resectable colorectal cancer during a short course before surgery. The trial is testing several such treatment approaches, followed by standard surgery.
The idea is that treating the cancer before surgery might produce a major pathological response, meaning little or no viable tumour is found in the removed tissue. This is measured as a sign of treatment activity; the trial does not compare treatments or establish whether patients live longer or avoid surgery.
Worth knowing: This is a non-randomised umbrella trial with several molecularly selected groups, and major pathological response is an early measure rather than proof of longer survival.
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 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/combinations given as a short-course pre-operative strategy, matched with the specific alteration detected, followed by standard of care surgery.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Not yet treated
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
General inclusion criteria
- Provide a signed and dated informed consent document.
- Age ≥ 18 years at time of informed consent.
- ECOG PS of 0 and 1.
- Histologically confirmed colorectal cancer adenocarcinoma that is judged as initially resectable with elective surgery aimed at radical intent with R0 margins as per multidisciplinary team assessment.
- Radiological stage cT3-4, N0-2, M0 using computed tomography (CT) as in the pivotal FOxTROT study.
- Patients with rectal cancer candidate for R0 resection, not requiring pre-operative radiotherapy based on multidisciplinary team assessment, with the following characteristics on high-resolution thin slice (3 mm) contrast-enhanced magnetic resonance imaging (MRI):
- ≤ T3a defined at the MRI (perivisceral fat infiltration <2 mm) and clinical N0
- Upper-medium, defined as tumors with distal margin ≥ 5 cm from the anal verge.
- Absence of mesorectal fascia invasion, as defined as a distance ≥ 1 mm between tumor and the mesorectal fascia.
- Able to provide enough archival FFPE tumor specimen that is already available from initial diagnostic procedures for the purpose of molecular pre-screening.
- Presence of one of the selected molecular profile/alteration after central pre-screening and necessary for the assignment to a matching treatment cohort.
- No prior systemic treatment for colorectal cancer o…
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 1 site. Listed in: Italy.
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 NCT05845450, registered by Gruppo Oncologico del Nord-Ovest 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.