Back to resultsColorectal Metastasis and Liver Transplantation With Organs From Deceased Donors (MELODIC)
Primary Purpose
Colorectal Liver Metastases, Colorectal Adenocarcinoma, Unresectable Malignant Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Liver Transplant
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Liver Metastases
Eligibility Criteria
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.
Sites / Locations
- U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di PadovaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Study arm
Parallel arm
Arm Description
Liver transplant
Chemotherapy
Outcomes
Primary Outcome Measures
Overall survival
Overall survival
Secondary Outcome Measures
Progression free survival
Proportion of drop out
Complication rate
Full Information
NCT ID
NCT04870879
First Posted
February 23, 2021
Last Updated
April 28, 2021
Sponsor
Azienda Ospedaliera di Padova
Collaborators
Istituto Oncologico Veneto IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT04870879
Brief Title
Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors
Acronym
MELODIC
Official Title
Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors: an Inductive Padova Center Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera di Padova
Collaborators
Istituto Oncologico Veneto IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Liver Metastases, Colorectal Adenocarcinoma, Unresectable Malignant Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study arm
Arm Type
Experimental
Arm Description
Liver transplant
Arm Title
Parallel arm
Arm Type
Other
Arm Description
Chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Liver Transplant
Intervention Description
Liver Transplant from cadaveric donors
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Chemotherapy
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Title
Overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
3 and 5 years
Title
Proportion of drop out
Time Frame
within liver transplant
Title
Complication rate
Time Frame
90 days after liver transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Umberto Cillo, MD
Phone
049.8212211-1897
Email
cillo@unipd.it
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Lonardi, MD
Email
sara.lonardi@iov.veneto.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umberto Cillo, MD
Organizational Affiliation
U.O.C Chirurgia Epatobiliare e dei Trapianti Epatici, AOPD
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umberto Cillo, MD
Email
cillo@unipd.it
First Name & Middle Initial & Last Name & Degree
Umberto Cillo, MD
12. IPD Sharing Statement
Learn more about this trial
Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors
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