Uveal melanoma is the most common primary intraocular malignancy in adults. Despite
successful control of the primary tumor, metastatic disease will ultimately develop in
approximately 50% of the patients. The liver is the most common site for metastases, and
about 50% of the patients will have isolated liver metastases. These metastases are
generally refractory to systemic chemotherapy and the median survival for patients with
liver metastases is about 6 months. Regardless of treatment, the mortality rate is
approximately 90% at 2 years with only about 1% of the patients surviving more than 5 years.
Isolated hepatic perfusion (IHP) is a regional treatment that was first performed more than
40 years ago (Aust and Ausman 1960). During IHP, the liver is completely isolated from the
systemic circulation, allowing a high concentration of chemotherapy to be perfused through
the liver with minimal systemic exposure. In a previous study from our institution, IHP was
analysed based on improvements in the procedure and the results showed an improved outcome
together with minimized morbidity and mortality over time.
A phase II follow-up study confirms that IHP is a promising technique with tolerable
morbidity. There are yet no randomized trials comparing overall survival in IHP, but in an
attempt to answer this question the investigators did a register study showing a 14 months
increased survival when comparing the patients treated with IHP with the longest surviving
patients in Sweden during the same time period.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
OS defined as the frequency of individuals alive at 24 months
24 months
No
Roger Olofsson, Dr
Principal Investigator
Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
Sweden: Regional Ethical Review Board
SUGBG-013001
NCT01785316
June 2013
June 2020
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