The Scandinavian Randomized Controlled Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases (SCANDIUM)
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|ClinicalTrials.gov Identifier: NCT01785316|
Recruitment Status : Recruiting
First Posted : February 7, 2013
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Uveal Neoplasms||Procedure: IHP||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Scandinavian Randomized Controlled Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2020|
Isolated Hepatic Perfusion
No Intervention: BAC
Best alternative care
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|