Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors

NCT ID: NCT04870879

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2025-10-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study arm

Liver transplant

Group Type: EXPERIMENTAL

Liver Transplant

Intervention Type: PROCEDURE

Liver Transplant from cadaveric donors

Parallel arm

Chemotherapy

Group Type: OTHER

Chemotherapy

Intervention Type: DRUG

Chemotherapy

Interventions

Liver Transplant

Liver Transplant from cadaveric donors

Intervention Type: PROCEDURE

Chemotherapy

Chemotherapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ≥ 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera di Padova

OTHER

Sponsor Role: lead

Responsible Party

Prof. Umberto Cillo

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Umberto Cillo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Padua, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Umberto Cillo, MD

Role: CONTACT

cillo@unipd.it

049.8212211-1897

Sara Lonardi, MD

Role: CONTACT

sara.lonardi@iov.veneto.it

Facility Contacts

Umberto Cillo, MD

Role: primary

cillo@unipd.it

Other Identifiers

AOP1840

Identifier Type: -

Identifier Source: org_study_id