Colorectal CancerTRASMETIRNCT04616495
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
An observational study of Colorectal Cancer and Metastatic Liver Cancer, run by Hospital Universitario La Fe at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Cancer, Metastatic Liver Cancer, Liver Metastases
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to Sep 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Cohort of patients detected in oncological units where they have been treated for colorectal cancer (stage IV with liver only unresectable metastases)
Who may be able to join
- ≥ 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Eva M Montalvá
Valencia, 46026
Eva M Montalvá, PhD, +34961245858, montalva.oron@gmail.com
About this study
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.
- Conditions
- Colorectal Cancer, Metastatic Liver Cancer, Liver Metastases
- Being tested
- Liver transplantation
- Medical subject headings
- Colorectal Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
Chemotherapy and liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Liver transplanted patients | Not described Receives: Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
five year overall survival (OS)
Measured: 5 years
Secondary outcomes (6)
one year disease free survival (DFS)
Measured: 1 year
three year disease free survival (DFS)
Measured: 3 years
five year disease free survival (DFS)
Measured: 5 years
Quality of life using EORTC questionnaires: QLQ-C30
Measured: 1 year
Quality of life using EORTC questionnaires: QLQ-C30
Measured: 3 years
Quality of life using EORTC questionnaires: QLQ-C30
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Sep 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva M. Montalvá, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616495
- Sponsor's protocol ID
- TRASMETIR
- Acronym
- TRASMETIR
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT04616495
- Acronym / sponsor ID
- TRASMETIR / TRASMETIR
- Conditions
- Colorectal Cancer, Metastatic Liver Cancer, Liver Metastases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplanted patients | – | Procedure: Liver transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cohort of patients detected in oncological units where they have been treated for colorectal cancer (stage IV with liver only unresectable metastases)
Key inclusion criteria (9 listed)
- ≥ 18 and ≤ years
- Good performance status, ECOG 0 or 1
- Resected adenocarcinoma in colon or rectum (R0 resection)
- Unresectable liver metastases
- No extrahepatic disease
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantationChemotherapy and liver transplantation | Procedure or surgery | Liver transplanted patients |
Primary outcome
five year overall survival (OS)
Time frame: 5 years
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Metastatic Liver Cancer, run by Hospital Universitario La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva M Montalvá, PhD (+34961245858, montalva.oron@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
five year overall survival (OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.