Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
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)
Sponsor: Japan Clinical Oncology Group
A PHASE3 clinical study on Malignant Pericardial Effusion, this trial is completed. The trial is conducted by Japan Clinical Oncology Group and has accumulated 6 data snapshots since 1999. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE3
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Sep 2024 — Present [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
Aug 1999
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Japan Clinical Oncology Group
- Ministry of Health, Labour and Welfare, Japan
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Asahikawa,Hanasaki,7-4048, Japan , Chuo-ku,Tsukiji, 5-1-1, Japan , Fukuoka,Higashi-ku,Maidashi,3-1-1, Japan , Gifu,Kashima-cho,7-1, Japan , Habikino,Habikino,3-7-1, Japan , Izumisano,rinku-ohrai-kita,2-23, Japan , Kashiwa,Kashiwanoha,6-5-1, Japan , Kita-adachi,Ina,Komuro,818, Japan , Kobe,Chuo-ku,Minatojimanakamachi,4-6, Japan , Koto-ku,Ariake,3-10-6, Japan and 21 more locations