COLT: Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation: a Prospective Parallel Trial - INT 108/18

Studio Clinico

Patologia: Epatocarcinoma, Tumori del colon retto

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: No

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

• 18 Years to 69 Years
• 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

Criteri di esclusione: 

• 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

Numero di pazienti previsti: 

22

Schema di trattamento: 

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

Trattamento sperimentale: 

Study arm - Liver transplant from cadaveric donors

Trattamento di controllo: 

Parallel arm - Chemotherapy (mFOLFOX // Panitumumab)

Obiettivi primari dello studio: 

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

Obiettivi secondari dello studio: 

• Progression Free Survival [Time Frame: 5 years]
  Time from enrolement to either progression or censoring
• Complications rate [Time Frame: 90 days after liver transplant]
  Complications according to Dindo Clavien Classification

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03803436

Data di inserimento: 16.04.2019

Data di aggiornamento: 28.03.2023

Promotore

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

CRO

/

Principal Investigator ITALIA

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Riferimento: Dr. Vincenzo Mazzaferro

Telefono: 0223902338

Email: vincenzo.mazzaferro@istitutotumori.mi.it

Localita: Milano