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

Phase 2

Recruiting

• Conditions: Liver Metastases; Colorectal Cancer Metastatic; Liver Neoplasm; Neoplasms
• Interventions: Procedure: Liver transplant; Drug: Chemotherapy

• Registration Number: NCT03803436
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study arm	Liver transplant	Liver transplant
Parallel arm	Chemotherapy	Chemotherapy

Primary Outcome Measures

Name	Time	Method
Overall Survival	5 years	Time from enrolement to either death or censoring

Secondary Outcome Measures

Name	Time	Method
Complications rate	90 days after liver transplant	Complications according to Dindo Clavien Classification
Progression Free Survival	5 years	Time from enrolement to either progression or censoring

Trial Locations

Locations (12)

Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

Azienda Ospedaliera Ospedale Niguarda Ca' Granda; 🇮🇹 Milano, Italy

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT); 🇮🇹 Palermo, Italy

Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine; 🇮🇹 Udine, Italy

ASST Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

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

Ospedale Maggiore di Milano Policlinico; 🇮🇹 Milano, Italy

Fondazione IRCCS Istituto NAzionale Tumori di Milano; 🇮🇹 Milan, 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.O.U. Integrata di Verona; 🇮🇹 Verona, Italy