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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04616495
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Eva M. Montalvá, Hospital Universitario La Fe

Study Description
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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.

Condition or disease Intervention/treatment
Colorectal Cancer Metastatic Liver Cancer Liver Metastases Procedure: Liver transplantation

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2028

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Liver transplanted patients Procedure: Liver transplantation
Chemotherapy and liver transplantation


Outcome Measures
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Primary Outcome Measures :
  1. five year overall survival (OS) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. one year disease free survival (DFS) [ Time Frame: 1 year ]
  2. three year disease free survival (DFS) [ Time Frame: 3 years ]
  3. five year disease free survival (DFS) [ Time Frame: 5 years ]
  4. Quality of life using EORTC questionnaires: QLQ-C30 [ Time Frame: 1 year ]
  5. Quality of life using EORTC questionnaires: QLQ-C30 [ Time Frame: 3 years ]
  6. Quality of life using EORTC questionnaires: QLQ-C30 [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04616495


Contacts
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Contact: Eva M Montalvá, PhD +34961245858 montalva.oron@gmail.com

Locations
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Spain
Eva M Montalvá Recruiting
Valencia, Spain, 46026
Contact: Eva M Montalvá, PhD    +34961245858    montalva.oron@gmail.com   
Sponsors and Collaborators
Hospital Universitario La Fe
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Eva M. Montalvá, Hepatobiliarypancreatic and Transplant Surgeon, Hospital Universitario La Fe
ClinicalTrials.gov Identifier: NCT04616495    
Other Study ID Numbers: TRASMETIR
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases