Clinical trial NCT04870879: Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors
Official title: Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors: an Inductive Padova Center Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Liver Metastases
Colorectal Adenocarcinoma
Unresectable Malignant Neoplasm
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
Collaborators: name: Istituto Oncologico Veneto IRCCS
First posted: 2021-05-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will compared survival in patient enrolled in the MELODIC trial with the OS in a matched cohort of patients treated with chemotherapy
Primary purpose: TREATMENT

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"


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 3 and 5 years
measure: Proportion of drop out
timeFrame: within liver transplant
measure: Complication rate
timeFrame: 90 days after liver transplant
Other outcomes:
Locations:
city: Padova
country: Italy
facility: U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
Study officials:
affiliation: U.O.C Chirurgia Epatobiliare e dei Trapianti Epatici, AOPD
name: Umberto Cillo, MD
role: PRINCIPAL_INVESTIGATOR
References: