The Swedish Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases (SCANDIUM)
A randomized controlled, open-label, multi-centre study evaluating if Isolated Hepatic Perfusion (IHP) increases Overall Survival compared with Best Alternative Care (BAC) in patients with isolated liver metastases from uveal melanoma.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]OS defined as the frequency of individuals alive at 24 months
- Hepatic progression-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]Defined as time from randomization to progress of existing lesions, or appearance of new lesions, within the liver according to RECIST criteria (version 1.1) using CT or MRI.
- Response [ Time Frame: 24 months ] [ Designated as safety issue: No ]Defined as best response according to RECIST criteria (version 1.1) using CT or MRI. For the BAC-group, during the whole follow-up of 24 months. For the IHP-group, until hepatic progression (the time point when cross-over to the BAC-group is allowed).
- Health economic evaluation [ Time Frame: 24 months ] [ Designated as safety issue: No ]Health economic evaluation measured using QALY calculated using EQ5D-3L at all study visits.
- SAE [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Number of Participants with SAE as a Measure of Safety
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2020|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Isolated Hepatic Perfusion
No Intervention: BAC
Best alternative care
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.
|Contact: Roger Olofsson, Dr||+46 31 email@example.com|
|Sahlgrenska University Hospital||Recruiting|
|Gothenburg, Sweden, 413 45|
|Contact: Roger Olofsson, Dr +46 31 3428207 firstname.lastname@example.org|
|Principal Investigator: Roger Olofsson, Dr|
|Principal Investigator:||Roger Olofsson, Dr||Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden|