Trials / Recruiting
RecruitingNCT01479608
Liver Transplantation and Colorectal Cancer
A Randomized Controlled Clinical Trial to Evaluate the Benefit and Efficacy of Liver Transplantation as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Colorectal liver metastases (CLM) are currently considered an absolute contraindication for liver transplantation (Lt) although Lt for other primary and secondary liver malignancies show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed, but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since then, several advances have been achieved and survival following Lt has improved by almost 30%. Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated. The investigators have previously included 21 patients in a pilot study. All patients had advanced CLM at the time of Lt. Long term overall survival (OS) exceeds by far previously reported outcome for this patient group and is comparable or better than survival following repeat Lt for non-malignant diagnoses. Development of robust selection criteria may further improve the results. The investigators will conduct a randomized controlled trial to explore whether liver transplantation in selected patients with liver metastases from CRC can obtain significant life extension and better health related quality of life compared to patients receiving surgical resection. The investigators will also explore if patient selection according to nomo-grams for outcome of colorectal cancer can define a subgroup of patients with a 5 year survival of at least 50% or even cure from the disease.
Detailed description
Arm D: use of extended criteria donors (ECD)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Liver transplantation and liver resection |
Timeline
- Start date
- 2012-04-11
- Primary completion
- 2025-12-01
- Completion
- 2027-12-01
- First posted
- 2011-11-24
- Last updated
- 2024-02-07
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT01479608. Inclusion in this directory is not an endorsement.