Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion

Phase 3

Completed

• Conditions: Malignant Pericardial Effusion
• Interventions: Drug: Pericardial instillation of bleomycin after drainage; Procedure: Observation alone after pericardial drainage

• Registration Number: NCT00132613
• Lead Sponsor: Japan Clinical Oncology Group

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.

Study Timeline

• Study Start: 1999-08
• Study First Submitted: 2005-08-19
• Study First Submitted QC: 2005-08-19
• Study First Posted: 2005-08-22
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Pericardial instillation of bleomycin after drainage	Drug: Pericardial instillation of bleomycin after drainage
1	Observation alone after pericardial drainage	Procedure/Surgery: Observation alone after pericardial drainage

Primary Outcome Measures

Name	Time	Method
Survival without pericardial effusion at 2 months

Secondary Outcome Measures

Name	Time	Method
Successful extubation of pericardial drainage tube
time to extubation
survival without pericardial effusion at 1, 2, 4, 6, 12 months
symptom palliation
complication
long-term (> 6 months) effect on cardiac function

Trial Locations

Locations (31)

Aichi Cancer Center,Aichi Hospital; 🇯🇵 Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan

Kyushu University Hospital; 🇯🇵 Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan

Osaka Prefectural Medical Center for Respiratory and Allergic Disease; 🇯🇵 Habikino,Habikino,3-7-1, Osaka, Japan

Tochigi Cancer Center; 🇯🇵 Utsunomiya,Yohnan,4-9-13, Tochigi, Japan

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama,Horinouchi,13, Ehime, Japan

International Medical Center of Japan; 🇯🇵 Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

Yamagata Prefectural Central Hospital; 🇯🇵 Yamagata,Aoyagi,1800, Yamagata, Japan

Gifu Municipal Hospital; 🇯🇵 Gifu,Kashima-cho,7-1, Gifu, Japan

Kanagawa Cancer Center; 🇯🇵 Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan

Niigata Cancer Center Hospital; 🇯🇵 Niigata,Kawagishi-cho,2-15-3, Niigata, Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases; 🇯🇵 Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan

Saitama Cancer Center; 🇯🇵 Kita-adachi,Ina,Komuro,818, Saitama, Japan

National Cancer Center Hospital; 🇯🇵 Chuo-ku,Tsukiji, 5-1-1, Tokyo, Japan

Cancer Institute Hospital; 🇯🇵 Koto-ku,Ariake,3-10-6, Tokyo, Japan

Aichi Cancer Center Hospital; 🇯🇵 Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan

National Hospital Organization Toneyama National Hospital; 🇯🇵 Toyonaka,Toneyama,5-1-1, Osaka, 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

Gunma Prefectural Cancer Center; 🇯🇵 Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan

Yokohama Mucipical Citizen's Hospital; 🇯🇵 Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan

Rinku General Medical Center; 🇯🇵 Izumisano,rinku-ohrai-kita,2-23, Osaka, Japan

National Nishigunma Hospital; 🇯🇵 Shibukawa,Kanai,2854, Gunma, 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

Kumamoto Regional Medical Center Hospital; 🇯🇵 Kumamoto,Honjo,5-16-10, Kumamoto, Japan

Tohoku University Hospital; 🇯🇵 Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan

Kinki University School of Medicine; 🇯🇵 Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan

Graduate School of Medicine, Osaka City University; 🇯🇵 Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, Japan

National Hospital Organization Kinki-Chuo Chest Medical Center; 🇯🇵 Sakai,Nagasone,1180, Osaka, Japan