Back to resultsLiver Transplantation and Uveal Malignant Melanoma
Primary Purpose
Uveal Malignant Melanoma
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Liver transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Uveal Malignant Melanoma focused on measuring Liver transplantation, Overall survival
Eligibility Criteria
Inclusion Criteria:
- Uveal malignant melanoma
- Liver metastases
- ECOG 0-1
Exclusion Criteria:
- Extra hepatic disease
- Previous other malignancy
- Previous organ transplantation
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liver transplantation
Arm Description
The liver transplantation will be performed as described by the standard protocol, Liver Transplantation Protocol (Version 2006) at the Oslo University Hospital
Outcomes
Primary Outcome Measures
Over all survival
Patient survival after livertransplantation
Secondary Outcome Measures
Full Information
NCT ID
NCT01311466
First Posted
March 7, 2011
Last Updated
October 20, 2017
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01311466
Brief Title
Liver Transplantation and Uveal Malignant Melanoma
Official Title
Open Non-randomized Study to Assess the Benefit of Liver Transplantation in Patients With Liver Metastasis After Ocular Malignant Melanoma (Uveal Melanoma)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
5. Study Description
Brief Summary
Patients with uveal malignant melanoma with liver metastases have median survival of less than 12 months. There is no established treatment showing increased overall survival. The study will determine if liver transplantation will result in long term survival in patients with liver metastases from uveal malignant melanoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Malignant Melanoma
Keywords
Liver transplantation, Overall survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liver transplantation
Arm Type
Experimental
Arm Description
The liver transplantation will be performed as described by the standard protocol, Liver Transplantation Protocol (Version 2006) at the Oslo University Hospital
Intervention Type
Procedure
Intervention Name(s)
Liver transplantation
Primary Outcome Measure Information:
Title
Over all survival
Description
Patient survival after livertransplantation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Uveal malignant melanoma
Liver metastases
ECOG 0-1
Exclusion Criteria:
Extra hepatic disease
Previous other malignancy
Previous organ transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svein Dueland, MD, PhD
Organizational Affiliation
Oslo University Hospital, Radium hospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
N0310
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Liver Transplantation and Uveal Malignant Melanoma
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