NCT02597348

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Feb 2016Jul 2026

First Submitted

Initial submission to the registry

October 23, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 14, 2024

Status Verified

January 1, 2024

Enrollment Period

10.4 years

First QC Date

October 23, 2015

Last Update Submit

February 12, 2024

Conditions

Liver MetastasisColorectal CancerMetastasis

Keywords

LiverMetastasisColorectal cancerLiver transplantation

Outcome Measures

Primary Outcomes (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.

    5 years

Secondary Outcomes (6)

  • 3-years overall survival (OS)

    3 years

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

    3 and 5 years

  • Recurrence rate at 3 and 5 years

    3 and 5 years

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

    year 5

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

    year 5

  • +1 more secondary outcomes

Study Arms (2)

Liver Transplantation

EXPERIMENTAL

Arm LT+C: patients will be treated by experimental liver transplantation preceding the non experimental standard chemotherapy (according to usual practices).

Procedure: Liver Transplantation

No intervention

NO INTERVENTION

Arm C: patients will receive non experimental standard chemotherapy according to usual practices in the context of definitively unresectable CLM.

Interventions

Liver TransplantationPROCEDURE

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

Also known as: Experimental LT+Non Experimental Usual Chimiotherapy
Liver Transplantation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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
  • Curative resection of primary tumor according to oncological principles
  • TNM adequate staging
  • 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)
  • +4 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP, Paul Brousse Hospital

Villejuif, 94800, France

Location

Related Publications (1)

  • 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.

    PMID: 39306468DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Officials

  • René ADAM, PhD

    AP-HP, Paul Brousse Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2015

First Posted

November 5, 2015

Study Start

February 1, 2016

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 14, 2024

Record last verified: 2024-01

Locations

FR(1)