MELODIC: Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors
Study Details
Study Description
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"
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study arm Liver transplant |
Procedure: Liver Transplant
Liver Transplant from cadaveric donors
|
| Other: Parallel arm Chemotherapy |
Drug: Chemotherapy
Chemotherapy
|
Outcome Measures
Primary Outcome Measures
- Overall survival [3 years]
- Overall survival [5 years]
Secondary Outcome Measures
- Progression free survival [3 and 5 years]
- Proportion of drop out [within liver transplant]
- Complication rate [90 days after liver transplant]
Eligibility Criteria
Criteria
Inclusion Criteria (Sythesis: 10;10;10;100):
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≥ 18 and <70 years
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Performance status, ECOG 0-1
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Histologically proved adenocarcinoma in colon or rectum.
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BRAF wild-type CRC on primary tumor or liver metastases
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High standard oncological surgical resection of the primary tumor
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Liver metastases not eligible for curative liver resection confirmed by the validation committee
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At least one line (3 months) of chemotherapy
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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
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Before start of chemotherapy no lesion should be larger than > 10 cm
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Objective response according to RECIST 1.1 or SD at two consecutive CT without CEA increase
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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
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At least 10 months time span from CRC resection and date of being listed on the transplantation list.
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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.
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CEA<100 ng/ml
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Signed informed consent and expected cooperation of the patients for the treatment and follow up
Exclusion Criteria:
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Weight loss >10% the last 6 months
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Patient BMI > 30
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Participation refusal
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General contraindication to LT
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Prior extra hepatic metastatic disease or primary tumor local relapse.
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Other malignancies in the previous 5 years
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Pregnancy or breast feeding
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Any reason why, in the opinion of the investigator, the patient should not participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova | Padova | Italy | 35128 |
Sponsors and Collaborators
- Azienda Ospedaliera di Padova
- Istituto Oncologico Veneto IRCCS
Investigators
- Principal Investigator: Umberto Cillo, MD, U.O.C Chirurgia Epatobiliare e dei Trapianti Epatici, AOPD
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AOP1840