RECRUITING

Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

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Conditions

Unresectable Liver-limited Colorectal Metastases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a single-arm, single institution pilot registry of liver transplantation in patients with unresectable colorectal liver-only metastases at Weill Cornell Medical College. Patients with liver predominant colorectal liver metastases will be screened based on eligibility criteria in a specified clinical hepatobiliary and colorectal liver metastasis tumor board consisting of the principal and co-investigators, representing medical oncology, transplant surgery, radiology, and pathology. The registry aims to track basic demographic data as well as referral patterns, in addition to specific oncologic data such as tumor burden, extent of disease, extent of disease on explant, recurrence rates, patterns of recurrence and survival rates.

Official Title

Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

Quick Facts

Study Start:2020-09-30
Study Completion:2035-07-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04742621

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically confirmed adenocarcinoma of the colon or rectum
  2. 2. No evidence of extrahepatic metastases or local recurrence based on PET/CT and colonoscopy
  3. 3. No signs of extrahepatic metastases or local recurrence according to PET/CT 4 weeks prior to consideration of transplant
  4. 4. Age 18-65 years old
  5. 5. Good performance status with ECOG 0-1
  6. 6. Stability or regression of liver metastasis for at least 6 months
  7. 7. Minimum of 1 year between diagnosis of colon cancer and liver transplant and 6 months from primary tumor resection and liver transplant
  8. 8. Minimum of 6 months chemotherapy
  9. 9. CEA \< 200 ug/L 3 months prior to transplant
  10. 10. Adequate organ and marrow function with Hb \> 10 g/dL, ANC \> 1000/uL, platelets \> 100,000/uL, bilirubin \< 2x ULN, AST/ALT \< 5x ULN, Creatinine \< 1.25 x ULN, Albumin above LLN
  1. 1. Evidence of extrahepatic disease or local recurrence
  2. 2. Previous resection of lung metastases
  3. 3. MSI-H/dMMR or BRAF mutation
  4. 4. Any other medical or co-morbid condition that would preclude liver transplantation, as determined by the transplant team

Contacts and Locations

Study Contact

Benjamin M Samstein, MD
CONTACT
212-746-2127
samstei@med.cornell.edu

Principal Investigator

Benjamin Samstein, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10075
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Benjamin Samstein, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-30
Study Completion Date2035-07-27

Study Record Updates

Study Start Date2020-09-30
Study Completion Date2035-07-27

Terms related to this study

Additional Relevant MeSH Terms

  • Unresectable Liver-limited Colorectal Metastases