Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors

NCT04870879 | Unknown DMC

• 1 other identifier: AOP1840
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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"

Conditions

Colorectal Liver Metastases; Colorectal Adenocarcinoma; Unresectable Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• Overall survival

  3 years

• Overall survival

  5 years

Secondary Outcomes (3)

• Progression free survival

  3 and 5 years

• Proportion of drop out

  within liver transplant

• Complication rate

  90 days after liver transplant

Study Arms (2)

Study arm

EXPERIMENTAL

Liver transplant

Procedure: Liver Transplant

Parallel arm

OTHER

Chemotherapy

Drug: Chemotherapy

Interventions

Liver Transplant PROCEDURE

Liver Transplant from cadaveric donors

Study arm

Chemotherapy DRUG

Chemotherapy

Parallel arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead
• Istituto Oncologico Veneto IRCCS: collaborator

Study Sites (1)

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

Padua, 35128, Italy

RECRUITING

MeSH Terms

Interventions

Liver Transplantation; Drug Therapy

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Umberto Cillo, MD

  U.O.C Chirurgia Epatobiliare e dei Trapianti Epatici, AOPD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Umberto Cillo, MD

CONTACT

049.8212211-1897; cillo@unipd.it

Sara Lonardi, MD

CONTACT

sara.lonardi@iov.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: The study will compared survival in patient enrolled in the MELODIC trial with the OS in a matched cohort of patients treated with chemotherapy

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: May 4, 2021
• Study Start: October 1, 2020
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 4, 2021

Record last verified: 2021-04

Locations

IT (1)