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)
2 other identifiers
interventional
80
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 1999
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1999
CompletedFirst Submitted
Initial submission to the registry
August 19, 2005
CompletedFirst Posted
Study publicly available on registry
August 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedSeptember 22, 2016
September 1, 2016
7.3 years
August 19, 2005
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival without pericardial effusion at 2 months
Secondary Outcomes (6)
Successful extubation of pericardial drainage tube
time to extubation
survival without pericardial effusion at 1, 2, 4, 6, 12 months
symptom palliation
complication
- +1 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORProcedure/Surgery: Observation alone after pericardial drainage
2
EXPERIMENTALDrug: Pericardial instillation of bleomycin after drainage
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681, Japan
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, 444-0011, Japan
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, 790-0007, Japan
Kyushu University Hospital
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582, Japan
Gifu Municipal Hospital
Gifu,Kashima-cho,7-1, Gifu, 500-8323, Japan
Gunma Prefectural Cancer Center
Ota,Takabayashi-nishi-cho,617-1, Gunma, 373-8550, Japan
National Nishigunma Hospital
Shibukawa,Kanai,2854, Gunma, 377-8511, Japan
National Hospital Organization, Dohoku National Hospital
Asahikawa,Hanasaki,7-4048, Hokkaido, 070-8644, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, 003-0804, Japan
Kobe City General Hospital
Kobe,Chuo-ku,Minatojimanakamachi,4-6, Hyōgo, 650-0046, Japan
Hyogo College of Medicine
Nishinomiya,Mukogawa-cho,1-1, Hyōgo, 663-8501, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, 309-1793, Japan
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815, Japan
Yokohama Mucipical Citizen's Hospital
Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, 240-8555, Japan
Kumamoto Regional Medical Center Hospital
Kumamoto,Honjo,5-16-10, Kumamoto, 860-0811, Japan
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574, Japan
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino,Habikino,3-7-1, Osaka, 583-8588, Japan
Rinku General Medical Center
Izumisano,rinku-ohrai-kita,2-23, Osaka, 598-0048, Japan
Graduate School of Medicine, Osaka City University
Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, 545-0051, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511, Japan
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, 589-8511, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai,Nagasone,1180, Osaka, 591-8555, Japan
National Hospital Organization Toneyama National Hospital
Toyonaka,Toneyama,5-1-1, Osaka, 560-8552, Japan
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, 362-0806, Japan
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834, Japan
National Cancer Center Hospital
Chuo-ku,Tsukiji, 5-1-1, Tokyo, 104-0045, Japan
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, 135-8550, Japan
International Medical Center of Japan
Shinjuku-ku,Toyama,1-21-1, Tokyo, 162-8655, Japan
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, 990-2292, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tomohide Tamura, MD
National Cancer Center Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 19, 2005
First Posted
August 22, 2005
Study Start
August 1, 1999
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
September 22, 2016
Record last verified: 2016-09