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

September 21, 2023 updated by: Eva M. Montalvá, Hospital Universitario La Fe
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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Recruiting
        • Eva M Montalvá
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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)
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
one year disease free survival (DFS)
Time Frame: 1 year
1 year
three year disease free survival (DFS)
Time Frame: 3 years
3 years
five year disease free survival (DFS)
Time Frame: 5 years
5 years
Quality of life using EORTC questionnaires: QLQ-C30
Time Frame: 1 year
1 year
Quality of life using EORTC questionnaires: QLQ-C30
Time Frame: 3 years
3 years
Quality of life using EORTC questionnaires: QLQ-C30
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Fe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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