Back to results

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

Primary Purpose

Liver Metastases, Colorectal Cancer Metastatic, Liver Neoplasm

Status

Recruiting

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Liver transplant

Chemotherapy

About this trial

This is an interventional treatment trial for Liver Metastases focused on measuring Liver Transplant, Colorectal Cancer, Chemotherapy, Metastasis

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona
ASST Papa Giovanni XXIII
Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino
Ospedale Maggiore di Milano PoliclinicoRecruiting
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Fondazione IRCCS Istituto NAzionale Tumori di MilanoRecruiting
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)Recruiting
GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial CoordinationRecruiting
Fondazione Policlinico Universitario A.Gemelli IRCCS
Ospedale Universitario Molinette S. Giovanni Battista di TorinoRecruiting
Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine
Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study arm

Parallel arm

Arm Description

Liver transplant

Chemotherapy

Outcomes

Primary Outcome Measures

Overall Survival

Time from enrolement to either death or censoring

Secondary Outcome Measures

Progression Free Survival

Time from enrolement to either progression or censoring

Complications rate

Complications according to Dindo Clavien Classification

Full Information

NCT ID

NCT03803436

First Posted

January 7, 2019

Last Updated

March 15, 2023

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03803436

Brief Title

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

Acronym

COLT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 2, 2019 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Metastases, Colorectal Cancer Metastatic, Liver Neoplasm, Neoplasms

Keywords

Liver Transplant, Colorectal Cancer, Chemotherapy, Metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study arm

Arm Type

Experimental

Arm Description

Liver transplant

Arm Title

Parallel arm

Arm Type

Active Comparator

Arm Description

Chemotherapy

Intervention Type

Procedure

Intervention Name(s)

Liver transplant

Intervention Description

Liver transplant from cadaveric donors

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

mFOLFOX

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

Panitumumab

Primary Outcome Measure Information:

Title

Overall Survival

Description

Time from enrolement to either death or censoring

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Progression Free Survival

Description

Time from enrolement to either progression or censoring

Time Frame

5 years

Title

Complications rate

Description

Complications according to Dindo Clavien Classification

Time Frame

90 days after liver transplant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vincenzo Mazzaferro, MD, PhD

Phone

+39 02 23902760

segreteria.mazzaferro@istitutotumori.mi.it

First Name & Middle Initial & Last Name or Official Title & Degree

Carlo Sposito, MD

Phone

+39 02 23903496

carlo.sposito@istitutotumori.mi.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincenzo Mazzaferro, MD, PhD

Organizational Affiliation

Fondazione IRCCS Istituto Nazionale Tumori di Milano

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Ancona

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marco Vivarelli, MD

Facility Name

ASST Papa Giovanni XXIII

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michele Colledan, MD

First Name & Middle Initial & Last Name & Degree

Domenico Pinelli, MD

Facility Name

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

City

Genova

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Enzo Andorno, MD

Facility Name

Ospedale Maggiore di Milano Policlinico

City

Milano

ZIP/Postal Code

20122

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giorgio Rossi, MD

First Name & Middle Initial & Last Name & Degree

Barbara Antonelli, MD

First Name & Middle Initial & Last Name & Degree

Paolo Reggiani, MD

Facility Name

Azienda Ospedaliera Ospedale Niguarda Ca' Granda

City

Milano

ZIP/Postal Code

20162

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luciano De Carlis, MD

First Name & Middle Initial & Last Name & Degree

Andrea Sartore Bianchi, MD

First Name & Middle Initial & Last Name & Degree

Stefano Di Sandro, MD

Facility Name

Fondazione IRCCS Istituto NAzionale Tumori di Milano

City

Milan

ZIP/Postal Code

20133

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Conte

Phone

+39 02 23902544

andrea.conte@istitutotumori.mi.it

First Name & Middle Initial & Last Name & Degree

Carlo Sposito, MD

First Name & Middle Initial & Last Name & Degree

Filippo Pietrantonio, MD

First Name & Middle Initial & Last Name & Degree

Vincenzo Mazzaferro, MD, PhD

Facility Name

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

City

Palermo

ZIP/Postal Code

90133

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Salvatore Gruttadauria, MD

First Name & Middle Initial & Last Name & Degree

Duilio Pagano, MD

Facility Name

GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination

City

Pisa

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alfredo Falcone, MD

First Name & Middle Initial & Last Name & Degree

Chiara Cremolini, MD

First Name & Middle Initial & Last Name & Degree

Carlotta Antoniotti, MD

Facility Name

Fondazione Policlinico Universitario A.Gemelli IRCCS

City

Roma

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alfonso Avolio, MD

Facility Name

Ospedale Universitario Molinette S. Giovanni Battista di Torino

City

Torino

ZIP/Postal Code

10126

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Renato Romagnoli, MD

Facility Name

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

City

Udine

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Umberto Baccarani, MD

Facility Name

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

City

Verona

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Umberto Tedeschi, MD

First Name & Middle Initial & Last Name & Degree

Paola Violi, MD

First Name & Middle Initial & Last Name & Degree

Amedeo Carraro, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs