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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132613
• Other study ID #: JCOG9811
• Secondary ID: C000000030
• Status: Completed
• Phase: Phase 3
• First received: August 19, 2005
• Last updated: September 20, 2016
• Start date: August 1999
• Est. completion date: November 2006

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Pericardial Effusion
• Pericardial Effusion

Intervention

Procedure:
• Observation alone after pericardial drainage

Drug:
• Pericardial instillation of bleomycin after drainage

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

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

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