Recruiting NCT04616495
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liver transplantation.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Metastatic Liver Cancer, Liver Metastases. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Liver transplantation
Chemotherapy and liver transplantation
Primary outcome measures
- five year overall survival (OS) [Time frame: 5 years]
Secondary outcome measures (6)
- one year disease free survival (DFS) [Time frame: 1 year]
- three year disease free survival (DFS) [Time frame: 3 years]
- five year disease free survival (DFS) [Time frame: 5 years]
- Quality of life using EORTC questionnaires: QLQ-C30 [Time frame: 1 year]
- Quality of life using EORTC questionnaires: QLQ-C30 [Time frame: 3 years]
- Quality of life using EORTC questionnaires: QLQ-C30 [Time frame: 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Eva M Montalvá — Valencia
Identifiers
NCT: NCT04616495 · TRASMETIR