Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors

Sponsor: Azienda Ospedaliera di Padova

Sommario: MELODIC trial is an prospective, multicenter, non-randomized, open-label, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in unresecable CRC liver-only metastases, compared with a matched cohort of patients bearing the same tumor characteristics, and treated with chemotherapy. Synthesis of Inclusion parameters: "10;10;10;100"

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TIPOLOGIA STUDIO

Interventistico

FASE

Non Disponibile

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TRATTAMENTO

• Liver Transplant
• Chemotherapy

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OBIETTIVO PRIMARIO

• Misura: Overall survival
• Tempo: 3 years
• Descrizione:

• Misura: Overall survival
• Tempo: 5 years
• Descrizione:

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OBIETTIVO SECONDARIO

• Misura: Progression free survival
• Tempo: 3 and 5 years
• Descrizione:

• Misura: Proportion of drop out
• Tempo: within liver transplant
• Descrizione:

• Misura: Complication rate
• Tempo: 90 days after liver transplant
• Descrizione:

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CRITERI DI ELIGIBILITA'

• Criteri di inclusione e esclusione

  Inclusion Criteria (Sythesis: 10;10;10;100): - ≥ 18 and <70 years - Performance status, ECOG 0-1 - Histologically proved adenocarcinoma in colon or rectum. - BRAF wild-type CRC on primary tumor or liver metastases - High standard oncological surgical resection of the primary tumor - Liver metastases not eligible for curative liver resection confirmed by the validation committee - At least one line (3 months) of chemotherapy - No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT within 4 weeks prior to the faculty meeting at the transplant unit - Before start of chemotherapy no lesion should be larger than > 10 cm - Objective response according to RECIST 1.1 or SD at two consecutive CT without CEA increase - Patient with less than 10% response on chemotherapy may be included if they obtain al least 20% response after TACE (DEB-IRI) or by 90Y-spheres - At least 10 months time span from CRC resection and date of being listed on the transplantation list. - Satisfactory blood tests Hb >10g/dL, neutrophils >1.0, Bilirubin<2 x upper normal level, AST, ALT<5 x upper normal level, creatinine and albumin in normal level. - CEA<100 ng/ml - Signed informed consent and expected cooperation of the patients for the treatment and follow up Exclusion Criteria: - Weight loss >10% the last 6 months - Patient BMI > 30 - Participation refusal - General contraindication to LT - Prior extra hepatic metastatic disease or primary tumor local relapse. - Other malignancies in the previous 5 years - Pregnancy or breast feeding - Any reason why, in the opinion of the investigator, the patient should not participate.

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SESSO

Tutti

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ETA' MINIMA

Età Minima: 18 Years
Età Massima: 70 Years

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LUOGO

U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
Padua 3171728, 35128

Contatto: Umberto Cillo, MD