Opening soonPhase 3Randomised
| Registry number | NCT07004413 |
|---|---|
| Recruitment | Opening soon |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 267 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Charite University, Berlin, Germany |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug FOLFIRI+cetuximab
- Test Guardant360 ctDNA assay
What it is measuring
Progression-free survival (PFS) on treatment rate at 12 months
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 goal of this clinical trial is to learn if the application of the chemotherapy FOLFIRI and cetuximab works better when given with scheduled breaks or continuously in adults with metastatic colorectal cancer. The main question it aims to answer is, whether worsening of disease after 12 months of treatment is lower when the treatment is given with breaks or given continuously. It will also answer the question whether the quality of life is better and side effects are less if chemotherapy is given with breaks.
Additionally, the treatment breaks will be controlled by blood tests and imaging examinations. A novel blood test will be introduced to investigate, whether worsening of the disease might be detected before the imaging, and whether a quicker reaction by re-starting the therapy would help the patients.
Participants will:
* receive an established chemotherapy mit FOLFIRI and cetuximab
* Receive blood tests every 4 weeks and imaging investigations every 12 weeks
* fill out questionnaires to report their quality of lifeWritten by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- RAS wild-type
- Metastatic
- Rectal
- Colon
- 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
1. Patient's signed informed consent
2. Histologically confirmed, UICC stage IV unresectable adenocarcinoma of the colon or rectum
3. Locally confirmed RAS/BRAF wild-type tumor status (KRAS and NRAS exon 2, 3, 4, BRAF exon 11/15)
a) Note: A maximum of two cycles FOLFIRI is allowed prior to start of induction treatment until the molecular characterization is fully reported
4. Centrally confirmed RAS/BRAF wild-type status by liquid biopsy during screening phase
5. Age 18 or older at the time of written informed consent
6. ECOG performance status below or equal 1
7. Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria
8. Archival tumor tissue available
9. Consent to storage, molecular and genetic profiling of tumor material and blood
10. Adequate bone marrow function:
1. Leukocytes ≥ 3.0 x 109/L with neutrophils ≥ 1.5 x 109/L
2. Thrombocytes ≥ 100 x 109/L
3. Hemoglobin ≥ 8 g/dL)
11. Adequate hepatic function:
1. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
2. ALAT and ASAT ≤ 2.5 x ULN (in the presence of hepatic metastases, ALAT and ASAT ≤ 5 x ULN)
3. INR < 1.5 and aPTT < 1.5 x ULN (patients without anticoagulation). Therapeutic anticoagulation is allowed if INR and aPTT have remained stable within the therapeutic range for at least 2 weeks.
12.
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: Germany.
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 NCT07004413, registered by Charite University, Berlin, Germany 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.