Opening soonPhase 3Randomised
| Registry number | NCT06446557 |
|---|---|
| Recruitment | Opening soon |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 408 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | University Hospital, Rouen |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug treatment adaptation guided by ctDNA variation
- Drug standard management
What it is measuring
Evaluate the superiority in quality-adjusted OS of an early treatment adaptation guided by ctDNA variation
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 are testing whether changes in circulating tumour DNA (ctDNA)—small fragments of tumour genetic material in the blood—after two chemotherapy cycles can show whether first-line treatment is working well enough to guide an early change in treatment. Depending on the ctDNA result, people whose cancer has not progressed may receive less treatment, stop chemotherapy, or switch treatment rather than continue the standard approach.
The idea is that ctDNA could identify people who may safely avoid some chemotherapy, while directing a treatment switch for those whose cancer appears less responsive. The trial measures whether this strategy improves quality-adjusted overall survival, meaning how long people live while also accounting for quality of life, compared with standard management.
Worth knowing: This strategy is being tested only in previously untreated, unresectable left-sided metastatic colorectal cancer that is microsatellite stable and BRAF V600E non-mutated; the record does not state that a particular RAS profile is required because treatment differs for RAS-wild-type and RAS-mutated tumours.
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
Background : In unresectable mCRC, a de-escalation strategy using maintenance or chemotherapy (CT) discontinuation in selected cases is considered as a valid option in non-progressive patients after a first-line induction of doublet CT + targeted agent (TA) (1-7).
In this context, circulating tumor DNA (ctDNA) is considered very promising to optimize decision making. Indeed, ctDNA harbour the same main alterations of the tumor and has been recognized as biologically relevant to reflect tumor dynamics and therapeutic efficacy (8).
As reported in mCRC, that early variation of ctDNA during CT may be relevant to predict outcome (9-11). Indeed, patients with a ctDNA decrease from the first (C1) to the third (C3) cycles of CT (∆≥80% or ctDNA<0.1 ng/ml at C3) or without ctDNA detectable at C1 and C3 have significant better survival as compared to patients with less decrease or with ctDNA increase (10).
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Rectal
- Colon
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 proven diagnosis of RAS WT or mutant, MSS, BRAFV600E non-mutated colorectal cancer.
- Left side or rectal cancer
- An unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
- At least one measurable lesion according to RECIST criteria version 1.1.
- Age ≥ 18 years.
- ECOG PS ≤ 1
- Neutrophils ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, Hb > 9 g/dl.
- Total bilirubin ≤ 1.5 time the upper-normal limits (UNL) and ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 x UNL, or 5 x UNL in case of liver metastases, alkaline phosphatase ≤ 2.5 x UNL, or 5 x UNL in case of liver metastases.
- Creatinine clearance > 50 mL/min or serum creatinine ≤ 1.5 x UNL.
- The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis.
- Adequate coagulation function [International Normalized Ratio (INR) ≤1.5 and Partial.
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: 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 NCT06446557, registered by University Hospital, Rouen 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.