Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases (TRASMETIR)

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Liver Metastases; Metastatic Liver Cancer
• Intervention / Treatment: Procedure: Liver transplantation

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Eva M Montalvá, PhD; Phone Number: +34961245858; Email: montalva.oron@gmail.com

Study Locations

• Spain
  • Valencia, Spain, 46026
    • Recruiting
    • Eva M Montalvá
    • Contact: Eva M Montalvá, PhD; Phone Number: +34961245858; Email: montalva.oron@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Cohort of patients detected in oncological units where they have been treated for colorectal cancer (stage IV with liver only unresectable metastases)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Liver transplanted patients	Procedure: Liver transplantation; Chemotherapy and liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
five year overall survival (OS)	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Quality of life using EORTC questionnaires: QLQ-C30	5 years

Collaborators and Investigators

• Sponsor: Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: TRASMETIR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No