NCT02597348 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: NA
Status at capture: UNKNOWN
Registry last update: 2024-02-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: Inclusion Criteria: * ≥ 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 * 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 Exclusion Criteria: * 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
healthy Volunteers: false
maximum Age: 65 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Arm LT+C: patients will be treated by experimental liver transplantation preceding the non experimental standard chemotherapy (according to usual practices).
intervention Names
Procedure: Liver Transplantation
label
Liver Transplantation
type
EXPERIMENTAL
description
Arm C: patients will receive non experimental standard chemotherapy according to usual practices in the context of definitively unresectable CLM.
label
No intervention
type
NO_INTERVENTION

interventions

arm Group Labels
Liver Transplantation
description
The patient of the arm LT+C are treated by experimental liver transplantation preceding the Non experimental standard chemotherapy (according to usual practices) .
name
Liver Transplantation
other Names
Experimental LT+Non Experimental Usual Chimiotherapy
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 94
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
5 years overall survival (OS)
time Frame
5 years

secondary Outcomes

measure
3-years overall survival (OS)
time Frame
3 years
measure
Disease free survival (DFS) (Arm LT+C) or Progression free survival (PFS) (Arm C)
time Frame
3 and 5 years
description
Radiological assessment will be performed according to the RECIST criteria and confirmed by 2 local radiologists.
measure
Recurrence rate at 3 and 5 years
time Frame
3 and 5 years
description
QLQ-C30 covers general aspects of health-related quality of life
measure
Quality of life (QOL) of patients using the European Organization for Research and Treatment of Cancer (EORTC) questionnaires.: QLQ-C30
time Frame
year 5
description
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
measure
Quality of life (QOL) of patients using the European Organization for Research and Treatment of Cancer (EORTC) questionnaires.: QLQ-LMC21
time Frame
year 5
measure
Quality of life (QOL) of patients of Group LT followed by chemotherapy, using the NIDDK questionnaire of Liver Transplantation Database
time Frame
year 5

Full study description

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.
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.

Source references

references

citation
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
39306468
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-7ad944f6deaf1f5cd6122126
edge id
nct-edge-1282b1aa2b7a19ba4aa8
requested nct id
NCT02597348
primary nct id
NCT02597348
source kind
nci_explicit_reference_or_link
source url
https://www.cancer.gov/types/colorectal/hp/colon-treatment-pdq
source record id
Source null
source file sha256
c3362deecde47509664af2cf063d6a1d02687d3d0ea0ee66f5973c4fee17def9
payload sha256
70e62c964f8ea5e11fbeb8b862b44cd57906f8cb8e15166fd6fda7ab93bac1ef
payload
clinical indication matching status
not_inferred
end exclusive
true
id
nct-edge-1282b1aa2b7a19ba4aa8
link basis
explicit_NCT_identifier_in_acquired_source
nct id
NCT02597348
occurrences
context exact
on=HealthProfessional&language=English'); return(false);">Level of evidence C3</a>] In the <a href="/clinicaltrials/NCT02597348">TRANSMET</a> study (NCT02597348), published in abstract form, 94 patients were randomly assigned to receive either chemotherapy and liver transplant (n = 47)
end
183400
exact text
NCT02597348
start
183389
context exact
e=English'); return(false);">Level of evidence C3</a>] In the <a href="/clinicaltrials/NCT02597348">TRANSMET</a> study (NCT02597348), published in abstract form, 94 patients were randomly assigned to receive either chemotherapy and liver transplant (n = 47) or chemotherapy alone (n = 47). I
end
183433
exact text
NCT02597348
start
183422
offset unit
unicode_code_points
source file
/tmp/cancer-full-research/nci/raw/610f1b1dfbdfdb9c66.html
source file sha256
c3362deecde47509664af2cf063d6a1d02687d3d0ea0ee66f5973c4fee17def9
source json pointer
Source null
source kind
nci_explicit_reference_or_link
source record id
Source null
source retrieved at
2026-09-09T23:21:38.940003+00:00
source string basis
UTF-8_text_with_universal_newline_translation
source string sha256
58f90914226eeac4b647c55350600c5f4db658e650463c199f43412e56552b42
source title
Colon Cancer Treatment (PDQ®)–Health Professional Version
source update dates
context
Updated: February 12, 2025
datetime
2025-02-12T12:00:00Z
display
February 12, 2025
source url
https://www.cancer.gov/types/colorectal/hp/colon-treatment-pdq
release id
ctgov-registry-7ad944f6deaf1f5cd6122126
edge id
nct-edge-9531458176da0a4137ee
requested nct id
NCT02597348
primary nct id
NCT02597348
source kind
nci_explicit_reference_or_link
source url
https://www.cancer.gov/types/colorectal/hp/rectal-treatment-pdq
source record id
Source null
source file sha256
a558d780598239714e125739b5bd8435388a575761b36a23c5dce5b640f02acf
payload sha256
35361081156d2c18e55c8c74e9b5d25c046f0dd9c7f827db6ac8cd0578bcc7f7
payload
clinical indication matching status
not_inferred
end exclusive
true
id
nct-edge-9531458176da0a4137ee
link basis
explicit_NCT_identifier_in_acquired_source
nct id
NCT02597348
occurrences
context exact
n=HealthProfessional&language=English'); return(false);">Level of evidence C3</a>] In the <a href="/clinicaltrials/NCT02597348">TRANSMET</a> study (NCT02597348), published in abstract form, 94 patients were randomly assigned to receive either chemotherapy and liver transplant (n = 47)
end
323413
exact text
NCT02597348
start
323402
context exact
=English'); return(false);">Level of evidence C3</a>] In the <a href="/clinicaltrials/NCT02597348">TRANSMET</a> study (NCT02597348), published in abstract form, 94 patients were randomly assigned to receive either chemotherapy and liver transplant (n = 47) or chemotherapy alone (n = 47). I
end
323446
exact text
NCT02597348
start
323435
offset unit
unicode_code_points
source file
/tmp/cancer-full-research/nci/raw/000ed4364d31964822.html
source file sha256
a558d780598239714e125739b5bd8435388a575761b36a23c5dce5b640f02acf
source json pointer
Source null
source kind
nci_explicit_reference_or_link
source record id
Source null
source retrieved at
2026-09-09T23:21:38.943216+00:00
source string basis
UTF-8_text_with_universal_newline_translation
source string sha256
387f265965c4b56957c6f58b4d8eb54b8d5a660b7f6ef6c433eff171e69dbb77
source title
Rectal Cancer Treatment (PDQ®)–Health Professional Version
source update dates
context
Updated: February 12, 2025
datetime
2025-02-12T12:00:00Z
display
February 12, 2025
source url
https://www.cancer.gov/types/colorectal/hp/rectal-treatment-pdq

Preserved source evidence · Independent clinical review pending · Not medical advice