Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors

Colorectal Adenocarcinoma Clinical Trial

— MELODIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04870879
• Other study ID #: AOP1840
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 2025

Study information

• Verified date: April 2021
• Source: Azienda Ospedaliera di Padova
• Contact: Umberto Cillo, MD
• Phone: 049.8212211-1897
• Email: cillo[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Adenocarcinoma
• Colorectal Liver Metastases
• Neoplasm Metastasis
• Neoplasms
• Unresectable Malignant Neoplasm

Intervention

Procedure:
• Liver Transplant
Liver Transplant from cadaveric donors

Drug:
• Chemotherapy
Chemotherapy

Locations

Country	Name	City	State
Italy	U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova	Padova

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova	Istituto Oncologico Veneto IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		3 years
Primary	Overall survival		5 years
Secondary	Progression free survival		3 and 5 years
Secondary	Proportion of drop out		within liver transplant
Secondary	Complication rate		90 days after liver transplant