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Liver MetastasisTRANSMETNCT02597348

Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases Treated by Chemotherapy

A study testing Liver Transplantation in people with Liver Metastasis and Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multicentric randomized parallel group open trial comparing 5-year survival of chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients with confirmed unresectable liver-only metastases, well controlled by chemotherapy (no progression) and extensively explored by modern… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Liver Metastasis, Colorectal Cancer, Metastasis
What is being tested?
Liver Transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteFrance
Study dates
Feb 2016to Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 and ≤ 65 years
  • Good performance status, ECOG 0 or 1 (39).
  • Histologically proved adenocarcinoma in colon or rectum
  • BRAF wild-type CRC on primary tumor or liver metastases
  • High standard oncological surgical resection of the primary defined by :
  • Safe margin of resection
Show all 20Show fewer
  • Curative resection of primary tumor according to oncological principles
  • TNM adequate staging
  • Absence of local recurrence on colonoscopy performed in the 12 months prior to inclusion (except in case of primary tumor resection < 12 months )
  • Confirmed non resectable colorectal liver metastases by the validation committee
  • ≥ 3 months of tumor control during the last chemotherapy line: Stable or Partial Response on RECIST criteria (40)
  • ≤ 3 lines of chemotherapy for metastatic disease
  • CEA < 80 microg/L or a decrease ≥ 50% of the highest serum CEA levels observed during the disease
  • Absence of extrahepatic tumor localisation according to CT scan and PET-CT
  • Renal function should be within the normal limits
  • No need for extra-renal purification procedure, hemodialysis or kidney transplantation associated (nephrologist assessment)
  • A platelet count> 80,000 / mm3
  • White blood cell count> 2500 / mm3
  • Eligible for both treatments groups
  • Signed informed consent and expected cooperation of the patient for the treatment and follow up

Who cannot join

  • Participation refusal
  • No health insurance facilities
  • General contraindication to LT (Severe cardiopulmonary disease or other life-limiting coexisting medical conditions, extrahepatic malignancy, active alcohol or substance abuse, active infection or uncontrolled sepsis, lack of psychosocial support or inability to comply with medical treatment)
  • Other malignancies either concomitant or within 5 years before liver transplantation
  • Patients not having received standard treatment for the primary CRC according to recommended guidelines
  • Prior extra hepatic metastatic disease or local relapse
  • Pregnancy at the time of inclusion

Trial locations and contacts

1 site in 1 country.

France1 site

  • AP-HP, Paul Brousse Hospital

    Villejuif, 94800

Other trials in France

About this study

Official title: Curative Potential of Liver Transplantation in Patients With Definitively Unresectable Colorectal Liver Metastases (CLM) Treated by Chemotherapy: a Prospective Multicentric Randomized Trial

This is a multicentric randomized parallel group open trial comparing 5-year survival of chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients with confirmed unresectable liver-only metastases, well controlled by chemotherapy (no progression) and extensively explored by modern imaging techniques. The primary objective of the trial is to validate in a large multicentric cohort of selected patients the possibility to obtain at least 50% 5-years survival with LT combined to chemotherapy compared to around 10% with chemotherapy alone.

Read the detailed description

Liver transplantation (LT) has recently been proposed as alternative treatment for definitively unresectable colorectal liver metastases in selected patients with a 60% estimated survival at 5 years in a recent prospective Norwegian study. However, disease free survival (DFS) in this preliminary study has been poor with 90% of recurrence after LT.

The objective of our study is to validate LT as a therapeutic option on a large multicentric scale throughout a highly strict policy selection in term of survival, disease free survival and quality of life. In order to reduce selection bias, unresectability criteria and theorical indication to LT will be confirmed by an independent Steering Committee including HPB surgeons, oncologists, radiologists and hepatologists.

Being tested
Liver Transplantation
Keywords
Liver, Metastasis, Colorectal cancer, Liver transplantation
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liver TransplantationProcedure or surgery

    Also called Experimental LT+Non Experimental Usual Chimiotherapy

    The patient of the arm LT+C are treated by experimental liver transplantation preceding the Non experimental standard chemotherapy (according to usual practices) .

Study groups in NCT02597348
Study groupRoleWhat they receive
Liver TransplantationExperimentalArm LT+C: patients will be treated by experimental liver transplantation preceding the non experimental standard chemotherapy (according to usual practices).
Receives: Procedure: Liver Transplantation
No interventionNo interventionArm C: patients will receive non experimental standard chemotherapy according to usual practices in the context of definitively unresectable CLM.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5 years overall survival (OS)

    The evaluation of 5-years overall survival will be conducted by constructing survival curves using the Kaplan-Meier method. Graphs will be created following the best practices defined by Pocock.

    • If the proportionality of hazards is respected: Survival in each randomization arm will be compared using the Log-Rank test. The hazard ratio and the associated 95% confidence interval will be estimated using a Cox proportional hazards model.
    • If the proportionality of hazards is not respected: the difference in Restricted Mean Survival Time (RMST) between the arms and the associated 95% confidence interval will be estimated.

    The randomization stratification by cluster of centers will not be taken into account in the analyses. This is because it was done for administrative reasons.

    Measured: 5 years

Secondary outcomes (6)

  1. 3-years overall survival (OS)

    Measured: 3 years

  2. Disease free survival (DFS) (Arm LT+C) or Progression free survival (PFS) (Arm C)

    Measured: 3 and 5 years

  3. Recurrence rate at 3 and 5 years

    Radiological assessment will be performed according to the RECIST criteria and confirmed by 2 local radiologists.

    Measured: 3 and 5 years

  4. Quality of life (QOL) of patients using the European Organization for Research and Treatment of Cancer (EORTC) questionnaires.: QLQ-C30

    QLQ-C30 covers general aspects of health-related quality of life

    Measured: year 5

  5. Quality of life (QOL) of patients using the European Organization for Research and Treatment of Cancer (EORTC) questionnaires.: QLQ-LMC21

    QLQ-LMC21 is valid and reliable questionnaire module to use with the QLQ-C30 in assessing in hepatectomy or palliative treatment for colorectal liver metastases

    Measured: year 5

  6. Quality of life (QOL) of patients of Group LT followed by chemotherapy, using the NIDDK questionnaire of Liver Transplantation Database

    Measured: year 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02597348
Sponsor's protocol ID
P130922
Acronym
TRANSMET
Status last verified
Jan 2024
First submitted
23 Oct 2015
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Adam R, Piedvache C, Chiche L, Adam JP, Salame E, Bucur P, Cherqui D, Scatton O, Granger V, Ducreux M, Cillo U, Cauchy F, Mabrut JY, Verslype C, Coubeau L, Hardwigsen J, Boleslawski E, Muscari F, Jeddou H, Pezet D, Heyd B, Lucidi V, Geboes K, Lerut J, Majno P, Grimaldi L, Levi F, Lewin M, Gelli M; Collaborative TransMet group. Liver transplantation plus chemotherapy versus chemotherapy alone in patients with permanently unresectable colorectal liver metastases (TransMet): results from a multicentre, open-label, prospective, randomised controlled trial. Lancet. 2024 Sep 21;404(10458):1107-1118. doi: 10.1016/S0140-6736(24)01595-2.

    PubMed 39306468

Questions about this trial

What is this clinical trial studying?

A study testing Liver Transplantation in people with Liver Metastasis and Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 20 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Feb 2024. 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 France. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5 years 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?

On the ClinicalTrials.gov record for NCT02597348, which also lists 1 linked publication.

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 14 Feb 2024.

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