Status:
UNKNOWN
Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors
Lead Sponsor:
Azienda Ospedaliera di Padova
Collaborating Sponsors:
Istituto Oncologico Veneto IRCCS
Conditions:
Colorectal Liver Metastases
Colorectal Adenocarcinoma
Eligibility:
All Genders
18-70 years
Phase:
NA
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 unresecabl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04870879
Start Date
October 1 2020
End Date
October 1 2025
Last Update
May 4 2021
Active Locations (1)
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1
U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
Padua, Italy, 35128