The Scandinavian Randomized Controlled Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases (SCANDIUM)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||The Scandinavian Randomized Controlled Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases|
- Overall survival [ Time Frame: 24 months ]OS defined as the frequency of individuals alive at 24 months
- Hepatic progression-free survival [ Time Frame: 24 months ]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 ]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 ]Health economic evaluation measured using QALY calculated using EQ5D-3L at all study visits.
- SAE [ Time Frame: 24 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785316
|Contact: Roger Olofsson Bagge, Dr||+46 31 firstname.lastname@example.org|
|Sahlgrenska University Hospital||Recruiting|
|Gothenburg, Sweden, 413 45|
|Contact: Roger Olofsson, Dr +46 31 3428207 email@example.com|
|Principal Investigator: Roger Olofsson, Dr|
|Principal Investigator:||Roger Olofsson Bagge, Dr||Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden|