Clinical trial NCT03803436: Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Metastases
Colorectal Cancer Metastatic
Liver Neoplasm
Neoplasms
Keywords: Liver Transplant
Colorectal Cancer
Chemotherapy
Metastasis
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
Collaborators: name: Istituto Di Ricerche Farmacologiche Mario Negri
name: Gruppo Oncologico del Nord-Ovest
First posted: 2019-01-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 5 years
measure: Complications rate
timeFrame: 90 days after liver transplant
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Genova
country: Italy
facility: Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: Ospedale Maggiore di Milano Policlinico
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto NAzionale Tumori di Milano
city: Palermo
country: Italy
facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
city: Pisa
country: Italy
facility: GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A.Gemelli IRCCS
city: Torino
country: Italy
facility: Ospedale Universitario Molinette S. Giovanni Battista di Torino
city: Udine
country: Italy
facility: Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine
city: Verona
country: Italy
facility: Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale Tumori di Milano
name: Vincenzo Mazzaferro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: