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NCT04616495 Clinical Trial

Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Colorectal Cancer Clinical Trial

— TRASMETIR  

Official title:
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04616495
Other study ID # TRASMETIR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 2028

Study information
Verified date September 2023
Source Hospital Universitario La Fe
Contact Eva M Montalvá, PhD
Phone +34961245858
Email montalva.oron@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date September 2028
Est. primary completion date September 2026
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - = 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 Exclusion Criteria: - Body mass index = 30 - Positive HIV or HCV - Pregnancy at the time of inclusion - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Liver transplantation
Chemotherapy and liver transplantation

Locations
Country Name City State
Spain Eva M Montalvá Valencia

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary five year overall survival (OS) 5 years
Secondary one year disease free survival (DFS) 1 year
Secondary three year disease free survival (DFS) 3 years
Secondary five year disease free survival (DFS) 5 years
Secondary Quality of life using EORTC questionnaires: QLQ-C30 1 year
Secondary Quality of life using EORTC questionnaires: QLQ-C30 3 years
Secondary Quality of life using EORTC questionnaires: QLQ-C30 5 years
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