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Trial record 2 of 74 for:    "Living Donors" | Recruiting, Not yet recruiting, Available Studies

Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases

This study is currently recruiting participants.
Verified October 2017 by University Health Network, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT02864485
First Posted: August 12, 2016
Last Update Posted: October 19, 2017
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.
Information provided by (Responsible Party):
University Health Network, Toronto
  Purpose
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 Intervention
Colorectal Cancer Liver Metastases Procedure: live donor liver transplantation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • patient survival [ Time Frame: 5 years ]
  • disease-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • patterns of cancer recurrence after liver transplantation [ Time Frame: 5 years ]
  • types of cancer recurrence treatments [ Time Frame: 5 years ]
  • 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 ]
  • 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)

  • 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)

  • patient survival [ Time Frame: 1 year ]
  • patient survival [ Time Frame: 3 years ]
  • disease-free survival [ Time Frame: 1 year ]
  • disease-free survival [ Time Frame: 3 years ]

Estimated Enrollment: 20
Study Start Date: August 2016
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: September 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transplantation
Live donor liver transplantation for the treatment of unresectable colorectal cancer liver metastases
Procedure: live donor liver transplantation
live donor liver transplantation

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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 or ≤N1
  • 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 liver resection (performed with curative intent) where current LM represent recurrent disease.
  • 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
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
Contact: Erin Winter, BSc 416-340-4800 ext 6093 erin.winter@uhn.ca

Locations
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
Principal Investigator: Gonzalo Sapisochin, MD University Health Network, Toronto
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02864485     History of Changes
Other Study ID Numbers: 15-9382-C
First Submitted: August 4, 2016
First Posted: August 12, 2016
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by University Health Network, Toronto:
Live donor liver transplantation

Additional relevant MeSH terms:
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
Liver Extracts
Hematinics