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 : July 13, 2018
|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 :||90 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 :||December 2019|
|Estimated Study Completion Date :||December 2021|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785316
|Contact: Roger Olofsson Bagge, Dr||+46 31 email@example.com|
|Sahlgrenska University Hospital||Recruiting|
|Gothenburg, Sweden, 413 45|
|Contact: Roger Olofsson Bagge, Dr +46 31 3428207 firstname.lastname@example.org|
|Principal Investigator: Roger Olofsson Bagge, Dr|
|Principal Investigator:||Roger Olofsson Bagge, Dr||Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden|