NCT04870879RecruitingNot Applicable
Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors: an Inductive Padova Center Protocol
Azienda Ospedaliera di Padova1 site in 1 country18 target enrollmentStarted: October 1, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Overall survival
Study Overview
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"
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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.
Arms & Interventions
Study arm
Experimental
Liver transplant
Intervention: Liver Transplant (Procedure)
Parallel arm
Other
Chemotherapy
Intervention: Chemotherapy (Drug)
Outcomes
Primary Outcomes
Overall survival
Time Frame: 5 years
Secondary Outcomes
- Progression free survival(3 and 5 years)
- Proportion of drop out(within liver transplant)
- Complication rate(90 days after liver transplant)
Investigators
Prof. Umberto Cillo
Prof
Azienda Ospedaliera di Padova
Study Sites (1)
Loading locations...
Similar Trials
Withdrawn
Phase 2
Sym004 in Metastatic Colorectal Cancer and ECD-EGFR PatientsMetastatic Colorectal CancerNCT02965417Symphogen A/S
Not yet recruiting
Phase 2
Fruquintinib Plus Camrelizumab and HAIC in the Treatment of Non-MSI-H Advanced Colorectal CancerColorectal CancerNCT06423937Fudan University129
Recruiting
Not Applicable
Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed ResectionLiver Transplant SurgeryColorectal Cancer MetastaticColon Cancer Liver MetastasesNCT06698146Northwestern University80
Not yet recruiting
Phase 3
Cetuximab Re-challenge for Colorectal Cancer Liver MetastasisLiver MetastasesCetuximabColorectal CancerNCT04509635Fudan University50
Terminated
Phase 2
The p53 Colorectal Cancer TrialColorectal Cancer MetastaticColorectal Cancer Stage IVTP53 Gene MutationNCT03149679Haukeland University Hospital12