Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Ca… (NCT03803436) | Clinical Trial Compass
UnknownPhase 2
Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation
Italy22 participantsStarted 2019-01-02
Plain-language summary
The COLT trial is an investigator-driven, multicenter, non-randomized, open-label, controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in liver-only CRC metastases, compared with a matched cohort of patients bearing the same tumor characteristics, collected during the same time period and included in a phase III Italian RCT on triplet chemotherapy+antiEGFR
Who can participate
Age range
18 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed non-mucinous colon adenocarcinoma.
* Primary tumor as pT1-3, pN0 or pN1 (metastases in \< 4 regional lymph nodes), confirmed R0 resection.
* RAS and BRAF wild-type \& MSS molecular status as per local testing.
* Liver metastases not eligible for curative liver resection
* Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (CR+PR+SD) during second-line treatment for at least 4 months.
* A maximum of two prior chemotherapy treatment lines.
* Performance status, ECOG 0.
* Satisfactory blood tests Hb \>10g/dl, neutrophils \>1.0 (after any G-CSF), TRC \>75, Bilirubin\<2 x upper normal level, AST, ALT\<5 x upper normal level, creatinine \<1.25 x upper normal level.
* CEA\<50 ng/ml
Exclusion Criteria:
* Hereditary CRC syndromes including FAP and Lynch syndrome.
* Prior extra hepatic metastatic disease or primary tumor local relapse.
* Extra-peritoneal cancers (rectum).
* Other malignancies in the previous 5 years
* Active intra-venous or alcohol abusers
* HIV infection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival
Timeframe: 5 years
Trial details
NCT IDNCT03803436
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano