Spots Global Cancer Trial Database for Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
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Trial Identification
Brief Title: Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
Official Title: A Randomized Controlled Trial to Evaluate the Efficacy of Intra-pericardial Instillation of a Sclerosing Agent After Pericardial Drainage in Patients With Malignant Pericardial Effusion Associated With Lung Cancer (JCOG9811)
Study ID: NCT00132613
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of pericardial instillation of bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial effusion.
Detailed Description: Malignant pericardial effusions (MPEs), which are commonly associated with cardiac tamponade, make oncologic emergencies requiring prompt drainage. In lung cancer patients, MPE is one of the most unpleasant terminal events. Drainage usually results in prompt palliation of symptoms, but recurrent effusions often occur. Sclerosis with pericardial instillation of various agents is reported to prevent the recurrence, and bleomycin is the most commonly used drug, with fewer toxicities compared with others. There is, however, no prospective trial of pericardial sclerosis as compared with drainage alone for MPEs, and it is far from clear whether sclerosis really benefits these patients in terminal stages. Comparison: Intra-pericardial instillation of bleomycin after pericardial drainage versus drainage alone for MPEs caused by lung cancer.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aichi Cancer Center Hospital, Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan
Aichi Cancer Center,Aichi Hospital, Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan
National Cancer Center Hospital East, Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama,Horinouchi,13, Ehime, Japan
Kyushu University Hospital, Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
Gifu Municipal Hospital, Gifu,Kashima-cho,7-1, Gifu, Japan
Gunma Prefectural Cancer Center, Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan
National Nishigunma Hospital, Shibukawa,Kanai,2854, Gunma, Japan
National Hospital Organization, Dohoku National Hospital, Asahikawa,Hanasaki,7-4048, Hokkaido, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan
Kobe City General Hospital, Kobe,Chuo-ku,Minatojimanakamachi,4-6, Hyogo, Japan
Hyogo College of Medicine, Nishinomiya,Mukogawa-cho,1-1, Hyogo, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center, Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan
Kanagawa Cancer Center, Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan
Yokohama Mucipical Citizen's Hospital, Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan
Kumamoto Regional Medical Center Hospital, Kumamoto,Honjo,5-16-10, Kumamoto, Japan
Tohoku University Hospital, Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Niigata Cancer Center Hospital, Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Disease, Habikino,Habikino,3-7-1, Osaka, Japan
Rinku General Medical Center, Izumisano,rinku-ohrai-kita,2-23, Osaka, Japan
Graduate School of Medicine, Osaka City University, Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan
Kinki University School of Medicine, Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai,Nagasone,1180, Osaka, Japan
National Hospital Organization Toneyama National Hospital, Toyonaka,Toneyama,5-1-1, Osaka, Japan
Saitama Cancer Center, Kita-adachi,Ina,Komuro,818, Saitama, Japan
Tochigi Cancer Center, Utsunomiya,Yohnan,4-9-13, Tochigi, Japan
National Cancer Center Hospital, Chuo-ku,Tsukiji, 5-1-1, Tokyo, Japan
Cancer Institute Hospital, Koto-ku,Ariake,3-10-6, Tokyo, Japan
International Medical Center of Japan, Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan
Yamagata Prefectural Central Hospital, Yamagata,Aoyagi,1800, Yamagata, Japan
Contact Details
Name: Tomohide Tamura, MD
Affiliation: National Cancer Center Hospital
Role: STUDY_CHAIR
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