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Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial) : study protocol for a randomized controlled trial

Olofsson, Roger, 1978 (author)
Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Dept Surg, S-41345 Gothenburg, Sweden,University of Gothenburg, Sweden
Ny, Lars, 1967 (author)
Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Dept Oncol, S-41345 Gothenburg, Sweden,University of Gothenburg, Sweden
All-Ericsson, Charlotta (author)
St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden
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Sternby Eilard, Malin Sternby (author)
Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Tranplant Inst, S-41345 Gothenburg, Sweden,University of Gothenburg, Sweden
Rizell, Magnus, 1963 (author)
Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Tranplant Inst, S-41345 Gothenburg, Sweden,University of Gothenburg, Sweden
Cahlin, Christian, 1959 (author)
Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Tranplant Inst, S-41345 Gothenburg, Sweden,University of Gothenburg, Sweden
Stierner, Ulrika, 1952 (author)
Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Dept Oncol, S-41345 Gothenburg, Sweden,University of Gothenburg, Sweden
Lönn, Ulf (author)
Östergötlands Läns Landsting,Linköpings universitet,Avdelningen för kliniska vetenskaper,Hälsouniversitetet,Onkologiska kliniken US
Hansson, Johan (author)
Karolinska Institutet
Ljuslinder, Ingrid (author)
Umeå universitet,Onkologi,Norrlands Univ Hosp, Dept Oncol, S-90185 Umea, Sweden,Norrlands University Hospital, Sweden
Lundgren, Lotta (author)
Lund University,Lunds universitet,Bröstcancer-genetik,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Breastcancer-genetics,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne Univ Hosp, Dept Oncol, S-22185 Lund, Sweden,Skåne University Hospital, Sweden
Ullenhag, Gustav (author)
Uppsala universitet,Enheten för onkologi,Uppsala University, Sweden
Kiilgaard, Jens Folke (author)
Univ Copenhagen, Glostrup Hosp, Dept Ophthalmol, DK-2600 Glostrup, Denmark,University of Copenhagen, Denmark
Nilsson, Jonas A, 1971 (author)
Gothenburg University,Göteborgs universitet,Sahlgrenska Cancer Center,Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Sahlgrenska Canc Ctr, S-40530 Gothenburg, Sweden,University of Gothenburg, Sweden
Lindnér, Per, 1956 (author)
Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Tranplant Inst, S-41345 Gothenburg, Sweden,University of Gothenburg, Sweden
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 (creator_code:org_t)
2014-08-09
2014
English.
In: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 15, s. 317-
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • Background: 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). Methods/Design: 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. Discussion: 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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kirurgi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Surgery (hsv//eng)

Keyword

Uveal melanoma
Liver metastases
Isolated hepatic perfusion
Regional treatment
Uveal melanoma
Liver metastases
Isolated hepatic perfusion
Regional
treatment

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art (subject category)

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