COLT: 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 (Other)

Overall Status

Recruiting

CT.gov ID

NCT03803436

Collaborator

Istituto Di Ricerche Farmacologiche Mario Negri (Other), Gruppo Oncologico del Nord-Ovest (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

1.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Liver Metastases Colorectal Cancer Metastatic Liver Neoplasm Neoplasms	Procedure: Liver transplant Drug: Chemotherapy Drug: Chemotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 2, 2019

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall Survival [5 years]
Time from enrolement to either death or censoring

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona	Ancona	Italy
2	ASST Papa Giovanni XXIII	Bergamo	Italy	24127
3	Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino	Genova	Italy
4	Ospedale Maggiore di Milano Policlinico	Milano	Italy	20122
5	Azienda Ospedaliera Ospedale Niguarda Ca' Granda	Milano	Italy	20162
6	Fondazione IRCCS Istituto NAzionale Tumori di Milano	Milan	Italy	20133
7	Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)	Palermo	Italy	90133
8	GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination	Pisa	Italy
9	Fondazione Policlinico Universitario A.Gemelli IRCCS	Roma	Italy
10	Ospedale Universitario Molinette S. Giovanni Battista di Torino	Torino	Italy	10126
11	Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine	Udine	Italy
12	Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona	Verona	Italy