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

Sommario: 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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TIPOLOGIA STUDIO

Interventistico

FASE

Fase 2

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TRATTAMENTO

• Liver transplant
• Chemotherapy
• Chemotherapy

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OBIETTIVO PRIMARIO

• Misura: Overall Survival
• Tempo: 5 years
• Descrizione: Time from enrolement to either death or censoring

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OBIETTIVO SECONDARIO

• Misura: Progression Free Survival
• Tempo: 5 years
• Descrizione: Time from enrolement to either progression or censoring

• Misura: Complications rate
• Tempo: 90 days after liver transplant
• Descrizione: Complications according to Dindo Clavien Classification

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CRITERI DI ELIGIBILITA'

• Criteri di inclusione e esclusione

  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

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SESSO

Tutti

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ETA' MINIMA

Età Minima: 18 Years
Età Massima: 69 Years

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LUOGO

ASST Papa Giovanni XXIII
Bergamo, 24127

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

Ospedale Maggiore di Milano Policlinico
Milano, 20122

Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milano, 20162

Fondazione IRCCS Istituto NAzionale Tumori di Milano
Milan, 20133

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
Palermo, 90133

GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination
Pisa,

Fondazione Policlinico Universitario A.Gemelli IRCCS
Roma,

Ospedale Universitario Molinette S. Giovanni Battista di Torino
Torino, 10126

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

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