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Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases

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ClinicalTrials.gov Identifier: NCT02864485
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : May 15, 2023
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:
Patients with unresectable liver metastases (LM) from colorectal cancer (CRC)have a poor prognosis. In patients with resectable disease, surgery offers a distinct survival benefit. This study will offer live donor liver transplantation (LDLT) to select patients with unresectable metastases that are 1) limited to the liver and 2) stable (non-progressing) on standard chemotherapy. Potential participants will be evaluated for liver transplant suitability and must also have a willing, healthy living donor come forward for evaluation. Those participants who undergo LDLT will be followed for survival, disease-free survival and quality of life for 5 years and compared to a "control group" of participants who drop out of study prior to transplantation due to reasons other than cancer progression.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Liver Metastases Procedure: live donor liver transplantation Not Applicable

Detailed Description:

Colorectal cancer (CRC) is a leading cause of cancer-related mortality worldwide. Approximately half of all patients develop metastases, often to the liver or lung. Surgical treatment of liver metastases (LM) is the only curative treatment option; however, it has been estimated that only 20-40% of patients are candidates for liver resection. Surgery offers a distinct survival advantage: the 5-year survival after liver resection for LM is around 40-50% in most studies versus 10-20% 5-year survival for chemotherapy alone.

In cases where the colorectal metastases are isolated to the liver but "unresectable", the total hepatectomy resulting from liver transplantation would remove all evident disease. CRC LM are considered an absolute contraindication for liver transplantation (LT) at most centers but recent reports of LT for colorectal LM from a single center in Oslo, Norway demonstrated a 5-year survival of 56%. The Norway study was not stringent about inclusion criteria or pre-transplant chemotherapy, and transplanted patients whose tumors were actively growing. As a result many participants developed disease recurrence quite rapidly following transplant. The investigators hypothesize that tighter criteria would result in improved outcomes.

Unfortunately, with a lack of deceased donor grafts for the investigators existing transplant patients, the investigators cannot utilize decease donor grafts for this study. Therefore the investigators will explore Living Donor Liver Transplantation (LDLT). Furthermore, LDLT is an elective surgery, allowing for more control over pre-transplant chemotherapy and tumor monitoring. This study will offer live donor liver transplantation (LDLT) to select patients with unresectable metastases that are 1) limited to the liver and 2) stable (non-progressing) on standard chemotherapy. Potential participants will be evaluated for liver transplant suitability and must also have a willing, healthy living donor come forward for evaluation. Those participants who undergo LDLT will be followed for survival, disease-free survival and quality of life for 5 years and compared to a "control group" of participants who drop out of study prior to transplantation due to reasons other than cancer progression.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of a Protocol Using a Combination of Neo-adjuvant Chemotherapy Plus Living Donor Liver Transplantation for Non-Resectable Liver Metastases From Colorectal Cancer
Actual Study Start Date : August 3, 2016
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: transplantation
Live donor liver transplantation for the treatment of unresectable colorectal cancer liver metastases
 Procedure: live donor liver transplantation
live donor liver transplantation


Outcome Measures
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Primary Outcome Measures :
  1. patient survival [ Time Frame: 5 years ]
  2. disease-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. patterns of cancer recurrence after liver transplantation [ Time Frame: 5 years ]
  2. types of cancer recurrence treatments [ Time Frame: 5 years ]
  3. Number of participants that drop out of study prior to receiving intervention (transplantation surgery) due to chemotherapy-related adverse events, as assessed by CTCAE v4.0 [ Time Frame: prior to liver transplantation ]
  4. self-reported quality of life as assessed by EORTC QLQ-C30 questionnaire [ Time Frame: 6 month intervals for 5 years ]
    Compare the QoL of participants undergoing intervention vs participants that drop-out (for non cancer related reasons and are thereafter receiving palliative chemotherapy)

  5. survival of intervention vs standard treatment [ Time Frame: 1-, 3- and 5 years ]
    Compare the 1-, 3- and 5- year survival of patients that undergo intervention with those that drop-out of the study (due to non-cancer related reasons and receive standard chemotherapy)

  6. patient survival [ Time Frame: 1 year ]
  7. patient survival [ Time Frame: 3 years ]
  8. disease-free survival [ Time Frame: 1 year ]
  9. disease-free survival [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must reside in Canada
  • ECOG ( Eastern Cooperative Oncology Group) score : 0-1 at all times prior to LDLT (excursions to ECOG 2 allowed at investigator's discretion)
  • Proven colorectal Liver Metastases (LM).
  • Willing and able to provide written informed consent.
  • Negative serum pregnancy test for women of childbearing potential
  • Both men and women must agree to use adequate barrier birth control measures during the course of the trial.
  • At least 1 "acceptable", ABO-compatible living donor has stepped forward
  • Primary Colorectal cancer tumor stage is ≤T4a
  • Time from primary CRC resection to transplant is ≥6 months
  • Bilateral and non-resectable LM
  • No major vascular invasion by LM; metastases isolated to liver
  • The patient has undergone systemic chemotherapy (eg. FOLFOX +/- bevacizumab or FOLFIRI +/- bevacizumab) for ≥3 months
  • demonstrated stability or regression of LM over at minimum the 3 months preceding screening
  • Carcinoembryonic Antigen (CEA) values are stable or decreasing at all timepoints prior to the transplant surgery.

Exclusion Criteria:

  • Previous or concurrent cancer (with some exceptions)
  • prior lung resection
  • Progression of LM at any timepoint prior to transplant surgery
  • Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
  • Pulmonary insufficiency
  • History of cardiac disease
  • Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B and/or C infection.
  • Patients with debilitating neuropathy. (CTCAE > grade 2)
  • BRAF + tumors
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Contacts and Locations
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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): NCT02864485


Contacts
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Contact: Erin Winter, BSc 416-340-4800 ext 6093 erin.winter@uhn.ca

Locations
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Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Erin Winter    416-340-4800 ext 6093    erin.winter@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Gonzalo Sapisochin, MD University Health Network, Toronto
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02864485    
Other Study ID Numbers: 15-9382-C
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: May 15, 2023
Last Verified: May 2023
Keywords provided by University Health Network, Toronto:
Live donor liver transplantation
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
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