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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03803436

Acronym

COLT

Enrollment

Registered

2019-01-14

Start date

2019-01-02

Completion date

2024-01-31

Last updated

2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Metastatic, Liver Metastases, Liver Neoplasm, Neoplasms

Keywords

Liver Transplant, Colorectal Cancer, Chemotherapy, Metastasis

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

Interventions

PROCEDURELiver transplant

Liver transplant from cadaveric donors

DRUGChemotherapy

mFOLFOX

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival	5 years	Time from enrolement to either death or censoring

Secondary

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactVincenzo Mazzaferro, MD, PhD

segreteria.mazzaferro@istitutotumori.mi.it+39 02 23902760

Backup ContactCarlo Sposito, MD

carlo.sposito@istitutotumori.mi.it+39 02 23903496

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026