Malignant Pericardial Effusion Clinical Trial
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)
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | November 2006 |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 75 Years |
Eligibility |
Inclusion Criteria: - Pathologically documented lung cancer - Clinically stable condition after pericardial drainage for malignant pericardial effusion (not necessary that it be documented by cytology) - Expected to live 6 weeks or longer - Sufficient organ function - Signed informed consent Exclusion Criteria: - Myocardial infarction or unstable angina within 3 months - Constrictive pericarditis - Active pneumonitis - Severe infection or disseminated intravascular coagulation (DIC) - Other severe co-morbidity which could not be relieved with pericardial drainage - Chemotherapy-naive small cell lung cancer |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | National Hospital Organization, Dohoku National Hospital | Asahikawa,Hanasaki,7-4048 | Hokkaido |
Japan | National Cancer Center Hospital | Chuo-ku,Tsukiji, 5-1-1 | Tokyo |
Japan | Kyushu University Hospital | Fukuoka,Higashi-ku,Maidashi,3-1-1 | Fukuoka |
Japan | Gifu Municipal Hospital | Gifu,Kashima-cho,7-1 | Gifu |
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 | National Cancer Center Hospital East | Kashiwa,Kashiwanoha,6-5-1 | Chiba |
Japan | Saitama Cancer Center | Kita-adachi,Ina,Komuro,818 | Saitama |
Japan | Kobe City General Hospital | Kobe,Chuo-ku,Minatojimanakamachi,4-6 | Hyogo |
Japan | Cancer Institute Hospital | Koto-ku,Ariake,3-10-6 | Tokyo |
Japan | Kumamoto Regional Medical Center Hospital | Kumamoto,Honjo,5-16-10 | Kumamoto |
Japan | National Hospital Organization Shikoku Cancer Center | Matsuyama,Horinouchi,13 | Ehime |
Japan | Aichi Cancer Center Hospital | Nagoya,Chikusa-ku,Kanokoden,1-1 | Aichi |
Japan | Niigata Cancer Center Hospital | Niigata,Kawagishi-cho,2-15-3 | Niigata |
Japan | Ibaraki Kenritsu Chuo Hospital & Cancer Center | Nishi-ibarakigun,Tomobemachi,Koibuchi,6528 | Ibaraki |
Japan | Hyogo College of Medicine | Nishinomiya,Mukogawa-cho,1-1 | Hyogo |
Japan | Aichi Cancer Center,Aichi Hospital | Okazaki,Kake-machi,Kuriyado,18 | Aichi |
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 | Gunma Prefectural Cancer Center | Ota,Takabayashi-nishi-cho,617-1 | Gunma |
Japan | National Hospital Organization Kinki-Chuo Chest Medical Center | Sakai,Nagasone,1180 | Osaka |
Japan | National Hospital Organization Hokkaido Cancer Center | Sapporo,Shiroishi-ku,Kikusui,4-2-3-54 | Hokkaido |
Japan | Tohoku University Hospital | Sendai,Aoba-ku,Seiryo-machi,1-1 | Miyagi |
Japan | National Nishigunma Hospital | Shibukawa,Kanai,2854 | Gunma |
Japan | International Medical Center of Japan | Shinjuku-ku,Toyama,1-21-1 | Tokyo |
Japan | National Hospital Organization Toneyama National Hospital | Toyonaka,Toneyama,5-1-1 | Osaka |
Japan | Tochigi Cancer Center | Utsunomiya,Yohnan,4-9-13 | Tochigi |
Japan | Yamagata Prefectural Central Hospital | Yamagata,Aoyagi,1800 | Yamagata |
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 |
Lead Sponsor | Collaborator |
---|---|
Japan Clinical Oncology Group | Ministry of Health, Labour and Welfare, Japan |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival without pericardial effusion at 2 months | |||
Secondary | Successful extubation of pericardial drainage tube | |||
Secondary | time to extubation | |||
Secondary | survival without pericardial effusion at 1, 2, 4, 6, 12 months | |||
Secondary | symptom palliation | |||
Secondary | complication | |||
Secondary | long-term (> 6 months) effect on cardiac function |
Status | Clinical Trial | Phase | |
---|---|---|---|
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