The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases (SOULMATE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04161092|
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : January 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Liver Metastases Colorectal Liver Metastases||Procedure: Liver transplantation Ltx Other: Best alternative care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled, Open-label, Multicentre Study Evaluating if Liver Transplantation With Liver Grafts From Extended Criteria Donors Not Utilised for Approved Indications Increases Overall Survival in Patients With Non-resectable Isolated Liver Metastases From Colorectal Metastases, in Comparison With Best Alternative Care|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||December 2029|
|Estimated Study Completion Date :||June 2030|
Liver transplantation + best alternative care
Patients subjected to Ltx will during the waiting time receive individualized chemotherapy, with the aim to avoid side effect that make them not transplantable.
If possible, patients randomized to Ltx should be treated within 12 weeks after randomization.
If the patients progress systemically they will be treated with best alternative care.
If they progress only within the liver they continue to be transplantable until they are deemed technically not transplantable by the transplant surgeon.
Procedure: Liver transplantation Ltx
Patients will be treated with Ltx at Sahlgrenska University Hospital, Göteborg, or Karolinska University Hospital, Huddinge.
Best alternative care
The treating physician will together with the patient decide the treatment.
Other: Best alternative care
All available treatments as well as other experimental treatments are tolerated, however no cross-over to other arm will be allowed.
- Five-year overall survival [ Time Frame: randomization to follow up at 5 years ]Percentage of subject who reach the endpoint of overall survival
- Two-year overall survival [ Time Frame: randomization to follow up at 2 years ]Percentage of subject who reach the endpoint of overall survival
- Median overall survival [ Time Frame: : Date of randomization until the date of death from any cause, assessed up to 5 years ]Defined as time to death
- Progression-free survival [ Time Frame: Date of randomization until the date of documented progression of existing lesions or appearance of new lesions, assessed up to 5 years ]Defined as time from randomization to progress of existing lesions, or appearance of new lesions, within the liver according to RECIST criteria (version 1.1) using CT or MRI and analysed using Kaplan-Meier and the log-rank test.
- Hepatic progression-free survival [ Time Frame: Date of randomization until the date of documented progression of existing lesions or appearance of new lesions in the liver, assessed up to 5 years ]Defined as time from randomization to progress of existing lesions in the liver , or appearance of new lesions in the liver, according to RECIST criteria (version 1.1) using CT or MRI and analysed using Kaplan-Meier and the log-rank test.
- Extrahepatic recurrence-free survival [ Time Frame: Date of randomization until the date of documented appearance of new extra-hepatic lesions, assessed up to 5 years ]Defined as time from randomization to appearance of new extra-hepatic lesions, using CT or MRI and analysed using Kaplan-Meier and the log-rank test.
- Changes in quality of Life assessed with Euroqol Group Questionaire 5D-3L (EQ-5D-3L) [ Time Frame: baseline, 3, 6, 12, 18, 24, 36 and 60 months ]Assessed with EQ-5D-3L
- Health economic evaluation [ Time Frame: baseline, 3, 6, 12, 18, 24, 36 and 60 months ]Estimation of Quality Adjusted Life Year (QALY) assessed with EQ-5D-3L
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): NCT04161092
|Contact: Per G Lindnér, MD, PhDemail@example.com|
|Contact: Helena Taflinfirstname.lastname@example.org|
|Transplant Institute, Sahlgrenska University Hospital||Recruiting|
|Contact: Veronica Reivell +46705129087 email@example.com|
|Transplantation Unit, Karolinska University Hospital||Not yet recruiting|
|Contact: Carl Jorns, MD, PhD +46762721845 firstname.lastname@example.org|
|Principal Investigator:||Per G Lindner, MD, PhD||Transplant Institute, Sahlgrenska University Hospital|
|Study Director:||Carl Jorns, MD, PhD||Transplantation Unit, Karolinska University Hospital|