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

NCT03803436 — Phase 2, Completed, 38 participants, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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

Registry	NCT03803436, acronym COLT
Status	Completed
Phase	Phase 2
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	38 (Actual)
Sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Other); collaborators: Istituto Di Ricerche Farmacologiche Mario Negri, Gruppo Oncologico del Nord-Ovest
Conditions	Liver Metastases, Colorectal Cancer Metastatic, Liver Neoplasm, Neoplasms
Interventions	Liver transplant, Chemotherapy (Procedure, drug)
Dates	start 2019-01-02, primary completion 2025-10-31, completion 2025-10-31, first posted 2019-01-14, last updated 2026-10-21
Locations	12 sites in Italy

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Study arm	Experimental	Procedure: Liver transplant	Liver transplant
Parallel arm	Active comparator	Drug: Chemotherapy	Chemotherapy

Liver transplant (Procedure): Liver transplant from cadaveric donors
Chemotherapy (Drug): mFOLFOX
Chemotherapy (Drug): Panitumumab

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

Sex: All, ages: 18 Years to 69 Years

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

+Locations (12)

Facility	City	Country
SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona	Ancona	Italy
ASST Papa Giovanni XXIII	Bergamo	Italy
Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino	Genova	Italy
Fondazione IRCCS Istituto NAzionale Tumori di Milano	Milan	Italy
Ospedale Maggiore di Milano Policlinico	Milan	Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda	Milan	Italy
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)	Palermo	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.S.U. Integrata di Udine	Udine	Italy
Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona	Verona	Italy

+Publications

Results publication: Sposito C, Pietrantonio F, Maspero M, Di Benedetto F, Vivarelli M, Tisone G, De Carlis L, Romagnoli R, Gruttadauria S, Colledan M, Agnes S, Ettorre G, Baccarani U, Torzilli G, Di Sandro S, Pinelli D, Caccamo L, Sartore Bianchi A, Spreafico C, Torri V, Mazzaferro V. Improving Outcome of Selected Patients With Non-Resectable Hepatic Metastases From Colorectal Cancer With Liver Transplantation: A Prospective Parallel Trial (COLT trial). Clin Colorectal Cancer. 2023 Jun;22(2):250-255. doi: 10.1016/j.clcc.2023.01.003. Epub 2023 Feb 3. PMID 36822922

+Investigators

Vincenzo Mazzaferro, MD, PhD, Principal investigator, Fondazione IRCCS Istituto Nazionale Tumori di Milano