Recruiting nowPhase 3Randomised
| Registry number | NCT03803553 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 400 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Massachusetts General Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug FOLFIRI Protocol
- Other ACTIVE SURVEILLANCE
- Drug Nivolumab Protocol
- Drug Encorafenib/Binimetinib/Cetuximab Protocol
- Drug Trastuzumab + Pertuzumab
What it is measuring
Disease-free survival (DFS)
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
This research study is comparing two standard of care treatment options based on blood test results for participants who have metastatic colon cancer.
The names of the potential treatments involved in this study are:
* Active surveillance
* FOLFIRI treatment
* Nivolumab treatment
* Encorafenib/Binimetinib/Cetuximab treatment
* Trastuzumab + PertuzumabWritten by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
- 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
- Participants must have histologically confirmed resected Stage III adenocarcinoma of the colon. Any T [Tx, T1, T2, T3, or T4-], N1-2M0.
- Participants must have completely resected disease. In patients with tumor adherent to adjacent structures, en block RO resection must be documented.
- Entire tumor must be in the colon (rectal involvement is excluded).
- Participants must have completed standard adjuvant chemotherapy per the discretion of the treating physician. Standard therapy includes FOLFOX, CAPOX, or therapy with 5FU analog alone will be permitted if it constitutes appropriate standard therapy in the opinion of the treating physician.
- Participants must not have received prior neoadjuvant chemotherapy.
- Age ≥18 years.
- ECOG performance status ≤1.
- Life expectancy of greater than 3 months.
- Participants must have normal organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/ mcL
- total bilirubin within normal institutional limits.
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 3 sites. Listed in: United States.
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 NCT03803553, registered by Massachusetts General Hospital 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.