RecruitingNot ApplicableNCT01479608

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


Sponsor

Oslo University Hospital

Enrollment

25 participants

Start Date

Apr 11, 2012

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether liver transplantation can be a treatment option for patients whose colorectal cancer (bowel cancer) has spread only to the liver and cannot be surgically removed — a situation where few other treatment options exist. **You may be eligible if...** - You have been diagnosed with colorectal (colon or rectal) cancer that has spread to the liver, confirmed by a biopsy - Scans (PET/CT, CT, or MRI) show the cancer has not spread to any other parts of the body - There is no sign the original bowel cancer has come back, confirmed by a recent colonoscopy or scan - You have received at least some chemotherapy already **You may NOT be eligible if...** - The cancer has spread beyond the liver to other parts of the body - The original bowel cancer has returned - You have not met the required observation period after your primary cancer treatment - You have other serious health conditions that would make transplant surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELiver transplantation and liver resection

Locations(1)

Oslo University Hospital

Oslo, Norway

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NCT01479608


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