Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
TRASMETIR
1 other identifier
observational
30
1 country
1
Brief Summary
Multicentric prospective and observational study to assess the 5-year overall survival in a cohort of patients with unresectable liver-only colorectal metastases, well controlled by chemotherapy prior to liver transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2020
CompletedFirst Posted
Study publicly available on registry
November 5, 2020
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
September 22, 2023
September 1, 2023
5 years
September 25, 2020
September 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
five year overall survival (OS)
5 years
Secondary Outcomes (6)
one year disease free survival (DFS)
1 year
three year disease free survival (DFS)
3 years
five year disease free survival (DFS)
5 years
Quality of life using EORTC questionnaires: QLQ-C30
1 year
Quality of life using EORTC questionnaires: QLQ-C30
3 years
- +1 more secondary outcomes
Study Arms (1)
Liver transplanted patients
Interventions
Eligibility Criteria
Cohort of patients detected in oncological units where they have been treated for colorectal cancer (stage IV with liver only unresectable metastases)
You may qualify if:
- ≥ 18 and ≤ years
- Good performance status, ECOG 0 or 1
- Resected adenocarcinoma in colon or rectum (R0 resection)
- Unresectable liver metastases
- No extrahepatic disease
- Normal blood tests
- Response to ≤ 2 lines of chemotherapy (RECIST criteria)
- ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list
- Signed informed consent
You may not qualify if:
- Body mass index ≥ 30
- Positive HIV or HCV
- BRAF mutated status
- Deterioration of general condition (10% weight loss in the prior 6 months)
- Other malignancy with disease free survival \< 5 years
- Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected.
- Palliative resection of primary colorectal adenocarcinoma
- Liver metastases size \> 5 cm (in the last imaging technique)
- CEA \> 80 ng/ml (at time of enrolment in waiting list)
- No neoadjuvant chemotherapy treatment
- General contraindication to liver transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eva M Montalvá
Valencia, 46026, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hepatobiliarypancreatic and Transplant Surgeon
Study Record Dates
First Submitted
September 25, 2020
First Posted
November 5, 2020
Study Start
September 1, 2021
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2028
Last Updated
September 22, 2023
Record last verified: 2023-09