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Brief Title: Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)
Official Title: Multicenter, Open-label, Randomized, Controlled Phase III Clinical Study of the Efficacy and Safety of Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Unresectable Advanced Perihilar Cholangiocarcinoma
Study ID: NCT02082522
Brief Summary: Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits light transmission) inserted into a flexible tube with a light called cholangioscope for the bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue, leading to its destruction. This research study will evaluate the efficacy and safety of PDT with porfimer sodium administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile ducts. It will involve 200 patients across North America and Europe. Other countries may participate if needed. Participation will last at least 18 months.
Detailed Description: Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits light transmission) inserted into a flexible tube with a light called cholangioscope for the bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue, leading to its destruction. Cholangiocarcinoma (CCA) is defined as primary malignant tumors of the bile ducts. The exact etiology remains unknown. These cancerous tumors block the bile flow and can be intrahepatic (IH) or extrahepatic (EH). The distinction between IH- and EH-CCA has become increasingly important, as the epidemiological features (i.e., incidence and risk factors), the biologic and pathologic characteristics and the clinical course are largely different. Unfortunately, most subjects are found to have metastases or unresectable disease at the time of diagnosis. Median survival for subjects with unresectable perihilar-CCA varies between five and eight months. The one-year survival is 50%, with 20% surviving at two years and 10% at three years. Unresected CCA is a rapidly fatal process with cholangitis being a significant cause of morbidity and mortality in these subjects. This study was designed to confirm the efficacy of PHOPDT + standard medical care (SMC) defined as stents plus gemcitabine/cisplatin chemotherapy regimen on the overall survival of subjects with unresectable cholestasis perihilar Bismuth type III or IV - tumor TNM stage III or IVa CCA.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Western Regional Medical Center, Inc., Goodyear, Arizona, United States
Mayo Clinic Cancer Center, Scottsdale, Arizona, United States
University of Southern California Keck School of Medicine, Los Angeles, California, United States
UC Davis Medical Center, Sacramento, California, United States
University of Colorado Denver, Aurora, Colorado, United States
Oschner Medical Center, Kenner, Louisiana, United States
Henry Ford Health System, Detroit, Michigan, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Cornell Medical College, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Southwestern Regional Medical Center, Inc., Tulsa, Oklahoma, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Allegheny Center for Digestive Health - AHN ASRI, Pittsburgh, Pennsylvania, United States
Methodist Dallas Medical Center, Dallas, Texas, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States
St. Michael's Hospital, Toronto, Ontario, Canada
CHUM Hôpital St-Luc, Montreal, Quebec, Canada
Klinikum Ludwigsburg, Ludwigsburg, Baden Wuerttemberg, Germany
Klinikum Mannheim GmbH, Mannheim, Baden Wuerttemberg, Germany
Johann-Wolfgang-Goethe Universität Frankfurt, Frankfurt, Hessen, Germany
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
Universitätsklinikum Essen (AöR), Essen, Nordrhein Westfalen, Germany
Konkuk University Medical Center, Seoul, Gwangjin-gu, Korea, Republic of
Soonchunhyang University Bucheon Hospital, Bucheon City, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seodaemun-gu, Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
UniversitätsSpital Zürich, Zürich, , Switzerland
Name: Michel Kahaleh, MD
Affiliation: Weill Medical College of Cornell University
Role: PRINCIPAL_INVESTIGATOR