Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial): study protocol for a randomized controlled trial
1 Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Blå stråket 5, 413 45 Gothenburg, Sweden
2 Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Blå stråket 5, 413 45 Gothenburg, Sweden
3 Transplant Institute, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden
4 Department of Oncology, Linköping University Hospital, Garnisonsvägen 10, 581 85 Linköping, Sweden
5 Department of Oncology, Karolinska University Hospital, Karolinska vägen, 171 76 Stockholm, Sweden
6 Department of Oncology, Norrlands University Hospital, 901 85 Umeå, Sweden
7 Department of Oncology, Skåne University Hospital, Getingevägen 4, 221 85 Lund, Sweden
8 Department of Radiology, Oncology and Radiation Science, Section of Oncology, Uppsala University, 751 05 Uppsala, Sweden
9 Department of Ophthalmology, Glostrup Hospital, Copenhagen University Hospital Glostrup, Nordre Ringvej 57, 2600, Glostrup, Denmark
10 Sahlgrenska Cancer Center, Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Medicinaregatan 1F, 405 30 Gothenburg, Sweden
Trials 2014, 15:317 doi:10.1186/1745-6215-15-317Published: 9 August 2014
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 patients, with the liver being the most common site for metastases. The median survival for patients with liver metastases is between 6 and 12 months, and no treatment has in randomized trials ever been shown to prolong survival. A previous phase II trial using isolated hepatic perfusion (IHP) has suggested a 14-month increase in overall survival compared with a historic control group consisting of the longest surviving patients in Sweden during the same time period (26 versus 12 months).
This is the protocol for a multicenter phase III trial randomizing patients with isolated liver metastases of uveal melanoma to IHP or best alternative care (BAC). Inclusion criteria include liver metastases (verified by biopsy) and no evidence of extra-hepatic tumor manifestations by positron emission tomography–computed tomography (PET-CT). The primary endpoint is overall survival at 24 months, with secondary endpoints including response rate, progression-free survival, and quality of life. The planned sample size is 78 patients throughout five years.
Patients with isolated liver metastases of uveal melanoma origin have a short expected survival and no standard treatment option exists. This is the first randomized clinical trial to evaluate IHP as a treatment option with overall survival being the primary endpoint.
ClinicalTrials.gov registration number: NCT01785316 (registered 1 February 2013). EudraCT registration number: 2013-000564-29.