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

March 15, 2023 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy
        • Not yet recruiting
        • SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona
        • Principal Investigator:
          • Marco Vivarelli, MD
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • Asst Papa Giovanni Xxiii
        • Principal Investigator:
          • Michele Colledan, MD
        • Sub-Investigator:
          • Domenico Pinelli, MD
      • Genova, Italy
        • Not yet recruiting
        • Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino
        • Principal Investigator:
          • Enzo Andorno, MD
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto NAzionale Tumori di Milano
        • Sub-Investigator:
          • Filippo Pietrantonio, MD
        • Contact:
        • Sub-Investigator:
          • Carlo Sposito, MD
        • Principal Investigator:
          • Vincenzo Mazzaferro, MD, PhD
      • Milano, Italy, 20122
        • Recruiting
        • Ospedale Maggiore di Milano Policlinico
        • Principal Investigator:
          • Giorgio Rossi, MD
        • Sub-Investigator:
          • Paolo Reggiani, MD
        • Sub-Investigator:
          • Barbara Antonelli, MD
      • Milano, Italy, 20162
        • Not yet recruiting
        • Azienda Ospedaliera Ospedale Niguarda CA' Granda
        • Principal Investigator:
          • Luciano De Carlis, MD
        • Sub-Investigator:
          • Andrea Sartore Bianchi, MD
        • Sub-Investigator:
          • Stefano Di Sandro, MD
      • Palermo, Italy, 90133
        • Recruiting
        • Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
        • Principal Investigator:
          • Salvatore Gruttadauria, MD
        • Sub-Investigator:
          • Duilio Pagano, MD
      • Pisa, Italy
        • Recruiting
        • GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination
        • Sub-Investigator:
          • Chiara Cremolini, MD
        • Sub-Investigator:
          • Carlotta Antoniotti, MD
      • Roma, Italy
        • Not yet recruiting
        • Fondazione Policlinico Universitario A.Gemelli IRCCS
        • Principal Investigator:
          • Alfonso Avolio, MD
      • Torino, Italy, 10126
        • Recruiting
        • Ospedale Universitario Molinette S. Giovanni Battista di Torino
        • Principal Investigator:
          • Renato Romagnoli, MD
      • Udine, Italy
        • Not yet recruiting
        • Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine
        • Principal Investigator:
          • Umberto Baccarani, MD
      • Verona, Italy
        • Not yet recruiting
        • Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona
        • Principal Investigator:
          • Umberto Tedeschi, MD
        • Sub-Investigator:
          • Paola Violi, MD
        • Sub-Investigator:
          • Amedeo Carraro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study arm
Liver transplant
Procedure: Liver transplant
Liver transplant from cadaveric donors
Active Comparator: Parallel arm
Chemotherapy
Drug: Chemotherapy
mFOLFOX
Drug: Chemotherapy
Panitumumab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborators

Istituto Di Ricerche Farmacologiche Mario Negri
Gruppo Oncologico del Nord-Ovest

Investigators

  • Principal Investigator: Vincenzo Mazzaferro, MD, PhD, Fondazione IRCCS Istituto NAzionale Tumori di Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2019

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT 108/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasms

Clinical Trials on Liver transplant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe