Colorectal Adenocarcinoma, Colorectal Liver Metastases, Unresectable Malignant Neoplasm
Conditions
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
Interventions
PROCEDURELiver Transplant
Liver Transplant from cadaveric donors
DRUGChemotherapy
Chemotherapy
Sponsors
Istituto Oncologico Veneto IRCCS
Azienda Ospedaliera di Padova
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | 3 and 5 years |
| Proportion of drop out | within liver transplant |
| Complication rate | 90 days after liver transplant |
Countries
Italy
Contacts
Primary ContactUmberto Cillo, MD
Backup ContactSara Lonardi, MD
Outcome results
None listed