Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases Treated by Chemotherapy (TRANSMET)
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|ClinicalTrials.gov Identifier: NCT02597348|
Recruitment Status : Recruiting
First Posted : November 5, 2015
Last Update Posted : September 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Liver Metastasis Colorectal Cancer Metastasis||Procedure: Liver Transplantation||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Curative Potential of Liver Transplantation in Patients With Definitively Unresectable Colorectal Liver Metastases (CLM) Treated by Chemotherapy: a Prospective Multicentric Randomized Trial|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||February 2027|
|Estimated Study Completion Date :||February 2027|
Experimental: Liver Transplantation
Arm LT+C: patients will be treated by experimental liver transplantation preceding the non experimental standard chemotherapy (according to usual practices).
Procedure: Liver Transplantation
The patient of the arm LT+C are treated by experimental liver transplantation preceding the Non experimental standard chemotherapy (according to usual practices) .
Other Name: Experimental LT+Non Experimental Usual Chimiotherapy
No Intervention: No intervention
Arm C: patients will receive non experimental standard chemotherapy according to usual practices in the context of definitively unresectable CLM.
- 5 years overall survival (OS) [ Time Frame: 5 years ]
- 3-years overall survival (OS) [ Time Frame: 3 years ]
- Disease free survival (DFS) (Arm LT+C) or Progression free survival (PFS) (Arm C) [ Time Frame: 3 and 5 years ]
- Recurrence rate at 3 and 5 years [ Time Frame: 3 and 5 years ]Radiological assessment will be performed according to the RECIST criteria and confirmed by 2 local radiologists.
- Quality of life (QOL) of patients using the European Organization for Research and Treatment of Cancer (EORTC) questionnaires.: QLQ-C30 [ Time Frame: year 5 ]QLQ-C30 covers general aspects of health-related quality of life
- Quality of life (QOL) of patients using the European Organization for Research and Treatment of Cancer (EORTC) questionnaires.: QLQ-LMC21 [ Time Frame: year 5 ]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
- Quality of life (QOL) of patients of Group LT followed by chemotherapy, using the NIDDK questionnaire of Liver Transplantation Database [ Time Frame: year 5 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597348
|Contact: René ADAM, PhD||+33 (0) 1 45 59 30 firstname.lastname@example.org|
|AP-HP, Paul Brousse Hospital||Recruiting|
|Villejuif, France, 94800|
|Contact: René ADAM, PhD +33 (0) 1 45 59 30 49 email@example.com|
|Principal Investigator:||René ADAM, PhD||AP-HP, Paul Brousse Hospital|