Spots Global Cancer Trial Database for Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC
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Trial Identification
Brief Title: Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC
Official Title: Randomized Controlled Trial Comparing Efficacy of Sorafenib Versus Sorafenib In Combination With Low Dose Cisplatin /Fluorouracil Hepatic Arterial InfUSion Chemotherapy in Patients With Advanced Hepatocellular Carcinoma
Study ID: NCT01214343
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of sorafenib in combination with low dose cisplatin /fluorouracil hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma.
Detailed Description: Sorafenib with Low-dose FP Group Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days. Cisplatin at the dose of 20mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330mg/m2 will be administered continuously at day1-day5, and day8-day12 via the implanted catheter system. Sorafenib Group Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days. The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Kurume University Medical Center, Kurume, Fukuoka, Japan
Ogaki Municipal Hospital, Ogaki, Gifu, Japan
Sapporo Medical University, Sapporo, Hokkaido, Japan
Sapporo-Kosei General Hospital, Sapporo, Hokkaido, Japan
Japanese Red Cross Takamatsu Hospital, Takamatsu, Kagawa, Japan
Mie University Hospital, Tsu, Mie, Japan
National Hospital Organization Nagasaki Medical Center, Ohmura, Nagasaki, Japan
Kawasaki Medical School Hospital, Kurashiki, Okayama, Japan
Ikeda Municipal Hospital, Ikeda, Osaka, Japan
Kinki University Hospital, Osaka-Sayama, Osaka, Japan
Osaka University Hospital, Suita, Osaka, Japan
Kyorin University Hospital, Mitaka, Tokyo, Japan
Musashino Red Cross Hospital, Musashino, Tokyo, Japan
Juntendo University Nerima Hospital, Nerima, Tokyo, Japan
Yamaguchi University Hospital, Ube, Yamaguchi, Japan
Chiba University Hospital, Chiba, , Japan
Gifu Municipal Hospital, Gifu, , Japan
Hiroshima City Hospital, Hiroshima, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Kyoto University Hospital, Kyoto, , Japan
Center for Gastroenterological and Hepatological Diseases, Miyazaki, , Japan
Saiseikai Niigata Dai-ni Hospital, Niigata, , Japan
Niigata University Medical and Dental Hospital, Niigata, , Japan
Okayama University Hospital, Okayama, , Japan
Osaka Red Cross Hospital, Osaka, , Japan
The University of Tokushima Faculty of Medicine, Tokushima, , Japan
Kyoundo Hospital, Tokyo, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Contact Details
Name: Masatoshi Kudo, Professor
Affiliation: Kinki University Faculty of Medicine, Department of Gastroenterology and Hepatology
Role: STUDY_CHAIR
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