28
Participants
Start Date
November 12, 2014
Primary Completion Date
January 12, 2017
Study Completion Date
January 12, 2017
Photodynamic therapy-Photofrin
Photodynamic therapy (PDT) involves the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device during an endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC). Two days after the injection, a laser light (180 J/cm(2)) will be applied to the tumor. A second light application will be given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients will undergo stenting as part of standard medical care procedure. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) may be given at 3-month intervals.
Stenting procedure
As per standard medical procedures, stenting procedure consists in the placement of stents above the main tumors of the right and left hepatic bile ducts via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) when the ERCP approach has been unsuccessful.
Chemotherapy regimen
The regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity.
UniversitätsSpital Zürich, Zurich
Weill Cornell Medical College, New York
Columbia University Medical Center, New York
SUNY Downstate Medical Center, Brooklyn
Roswell Park Cancer Institute, Buffalo
Allegheny Center for Digestive Health - AHN ASRI, Pittsburgh
Thomas Jefferson University, Philadelphia
Duke University Medical Center, Durham
Medizinische Hochschule Hannover, Hanover
Henry Ford Health System, Detroit
Johann-Wolfgang-Goethe Universität Frankfurt, Frankfurt am Main
Klinikum Mannheim GmbH, Mannheim
Oschner Medical Center, Kenner
Klinikum Ludwigsburg, Ludwigsburg
Southwestern Regional Medical Center, Inc., Tulsa
Methodist Dallas Medical Center, Dallas
University of Colorado Denver, Aurora
Western Regional Medical Center, Inc., Goodyear
UC Davis Medical Center, Sacramento
Virginia Mason Medical Center, Seattle
Providence Sacred Heart Medical Center and Children's Hospital, Spokane
Mayo Clinic Cancer Center, Scottsdale
University of Southern California Keck School of Medicine, Los Angeles
St. Michael's Hospital, Toronto
CHUM Hôpital St-Luc, Montreal
Universitätsklinikum Essen (AöR), Essen
Konkuk University Medical Center, Seoul
Soonchunhyang University Bucheon Hospital, Bucheon-si
Seoul National University Bundang Hospital, Seongnam-si
Severance Hospital, Yonsei University Health System, Seoul
Seoul National University Hospital, Seoul
Lead Sponsor
Concordia Laboratories Inc.
INDUSTRY