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COMPLETED
NCT03803436
PHASE2

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

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2019-01-02

Completion Date

2025-10-31

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

PROCEDURE

Liver transplant

Liver transplant from cadaveric donors

DRUG

Chemotherapy

mFOLFOX

DRUG

Chemotherapy

Panitumumab

Locations (12)

SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona

Ancona, Italy

ASST Papa Giovanni XXIII

Bergamo, Italy

Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino

Genova, Italy

Fondazione IRCCS Istituto NAzionale Tumori di Milano

Milan, Italy

Ospedale Maggiore di Milano Policlinico

Milan, Italy

Azienda Ospedaliera Ospedale Niguarda Ca' Granda

Milan, Italy

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

Palermo, Italy

GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination

Pisa, Italy

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, Italy

Ospedale Universitario Molinette S. Giovanni Battista di Torino

Torino, Italy

Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine

Udine, Italy

Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona

Verona, Italy