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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
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Brief Summary:
To evaluate if the addition of liver transplantation primarily utilizing liver grafts from extended criteria donors not utilized for approved indications to conventional treatment of non-resectable/ non-abatable colorectal liver metastases (CLM) increases overall survival compared to best alternative care.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Liver Metastases Colorectal Liver Metastases Procedure: Liver transplantation Ltx Other: Best alternative care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Five-year overall survival [ Time Frame: randomization to follow up at 5 years ]
    Percentage of subject who reach the endpoint of overall survival


Secondary Outcome Measures :
  1. Two-year overall survival [ Time Frame: randomization to follow up at 2 years ]
    Percentage of subject who reach the endpoint of overall survival

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with non-resectable, non-ablatable liver metastases from colorectal adenocarcinoma.
  • Male or female 18 years or above.
  • Primary tumour removed with an R0 resection, and histologically verified adenocarcinoma from colon or rectum
  • Liver metastases measurable by MRI or CT according to RECIST version 1.1 Imaging within 4 weeks prior to inclusion.
  • No signs of extrahepatic metastatic disease or local recurrence according to MRI and CT of thorax/abdomen and whole body Positron-emission tomography (PET)/ computed tomography (CT) scan.
  • A colonoscopy performed within the last 12 months in order to exclude multifocal colorectal cancer (CRC) tumours.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Satisfactory blood tests: Hb ≥ 90 g/L (transfusions are permitted to achieve baseline hemoglobin level), White blood cell Count (WBC) >3,0x109/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet Count (PLT) >75, Bilirubin<2 x upper normal level, Aspartate aminotransferase (ASAT), Alanine aminotransferase (ALAT)<5 x upper normal level, Calculated Creatinine clearance ≥ 50 mL/min(MDRD).
  • Received at least 2 months of chemotherapy with no signs of progressive disease according to RECIST-criteria at the last evaluation before randomization.
  • One year or more from the initial CRC diagnosis to the date of inclusion in the study
  • Patient accepted for transplantation by a national study board
  • Signed and dated written informed consent before the start of specific protocol procedures.

Exclusion Criteria:

  • Evidence of extrahepatic disease by PET-CT or CT-thorax/abdomen.
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study.
  • Weight loss >10% the last 6 months
  • Other malignancies within the last 5 years, except CRC and low risk tumours such as basaliomas.

    * Liver metastases larger than 10 cm.

  • Pathological lymphatic nodes in the abdomen. If a patient has pathological lymphatic nodules in the hepatoduodenal ligament, a staging operation with histo-pathological examination from the nodules with no signs of tumour cell involvement has to be performed before inclusion.
  • BRAF (a gene that encodes a protein called b-raf) mutation in primary tumour
  • microsatellite instability (MSI-H) in primary tumour
  • Previous organ transplantation

Information from the National Library of Medicine

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


Contacts
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Contact: Per G Lindnér, MD, PhD +46705548400 per.lindner@vgregion.se
Contact: Helena Taflin +46700824799 helena.taflin@vgregion.se

Locations
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Sweden
Transplant Institute, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Veronica Reivell    +46705129087    veronica.reivell@vgregion.se   
Transplantation Unit, Karolinska University Hospital Not yet recruiting
Stockholm, Sweden
Contact: Carl Jorns, MD, PhD    +46762721845    carl.jorns@sll.se   
Sponsors and Collaborators
Vastra Gotaland Region
Investigators
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Principal Investigator: Per G Lindner, MD, PhD Transplant Institute, Sahlgrenska University Hospital
Study Director: Carl Jorns, MD, PhD Transplantation Unit, Karolinska University Hospital
Publications:

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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT04161092    
Other Study ID Numbers: SOULMATE
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vastra Gotaland Region:
colorectal cancer
liver metastases
liver transplant
non-resectable colorectal cancer metastases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases