Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors (MELODIC)

Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors: an Inductive Padova Center Protocol

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"

Study Overview

• Status: Recruiting
• Conditions: Colorectal Adenocarcinoma; Colorectal Liver Metastases; Unresectable Malignant Neoplasm
• Intervention / Treatment: Procedure: Liver Transplant; Drug: Chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Lonardi, MD; Email: sara.lonardi@iov.veneto.it
• Study Contact Backup: Name: Umberto Cillo, MD; Phone Number: 049.8212211-1897; Email: cillo@unipd.it

Study Locations

• Italy
  • Padova, Italy, 35128
    • Recruiting
    • U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
    • Contact: Umberto Cillo, MD; Email: cillo@unipd.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm; Liver transplant	Procedure: Liver Transplant; Liver Transplant from cadaveric donors
Other: Parallel arm; Chemotherapy	Drug: Chemotherapy; Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 years
Overall survival	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	3 and 5 years
Proportion of drop out	within liver transplant
Complication rate	90 days after liver transplant

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Padova
• Collaborators: Istituto Oncologico Veneto IRCCS
• Investigators: Principal Investigator: Umberto Cillo, MD, U.O.C Chirurgia Epatobiliare e dei Trapianti Epatici, AOPD

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): October 1, 2025
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: AOP1840

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No