Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation

Study Overview
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Brief Summary
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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

Official Title
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Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation: a Prospective Parallel Trial

Conditions
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Liver Metastases, Colorectal Cancer Metastatic, Liver Neoplasm, Neoplasms

Intervention / Treatment
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* Procedure: Liver transplant
* Drug: Chemotherapy
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will compare survival in the population of patients enrolled in the COLT trial with the OS in the COLT-eligible population enrolled in the parallel TRIPLETE trial conducted by the GONO Group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>Liver transplant | Procedure: Liver transplant<br>* Liver transplant from cadaveric donors<br>|
| Active Comparator: Parallel arm<br>Chemotherapy | Drug: Chemotherapy<br>* mFOLFOX<br>Drug: Chemotherapy<br>* Panitumumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Time from enrolement to either death or censoring | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Time from enrolement to either progression or censoring | 5 years | 
| Complications rate | Complications according to Dindo Clavien Classification | 90 days after liver transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Transplant, Colorectal Cancer, Chemotherapy, Metastasis