Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Istituto Oncologico Veneto IRCCS | OTHER |
Not provided
Not provided
Not provided
Not provided
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"
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Liver transplant |
|
| Parallel arm | Other | Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver Transplant | Procedure | Liver Transplant from cadaveric donors |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 years | |
| Overall survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 3 and 5 years | |
| Proportion of drop out | within liver transplant | |
| Complication rate |
Not provided
Inclusion Criteria (Sythesis: 10;10;10;100):
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Umberto Cillo, MD | Contact | 049.8212211-1897 | cillo@unipd.it | |
| Sara Lonardi, MD | Contact | sara.lonardi@iov.veneto.it |
| Name | Affiliation | Role |
|---|---|---|
| Umberto Cillo, MD | U.O.C Chirurgia Epatobiliare e dei Trapianti Epatici, AOPD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova | Recruiting | Padova | 35128 | Italy |
Not provided
| ID | Term |
|---|---|
| D016031 | Liver Transplantation |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
The study will compared survival in patient enrolled in the MELODIC trial with the OS in a matched cohort of patients treated with chemotherapy
Not provided
Not provided
Not provided
Not provided
| Chemotherapy |
| Drug |
Chemotherapy |
|
| 90 days after liver transplant |
| D013505 |
| Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |