We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00132613
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : September 22, 2016
Ministry of Health, Labour and Welfare, Japan
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Malignant Pericardial Effusion Procedure: Observation alone after pericardial drainage Drug: Pericardial instillation of bleomycin after drainage Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : August 1999
Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Procedure/Surgery: Observation alone after pericardial drainage
Procedure: Observation alone after pericardial drainage
Experimental: 2
Drug: Pericardial instillation of bleomycin after drainage
Drug: Pericardial instillation of bleomycin after drainage

Primary Outcome Measures :
  1. Survival without pericardial effusion at 2 months

Secondary Outcome Measures :
  1. Successful extubation of pericardial drainage tube
  2. time to extubation
  3. survival without pericardial effusion at 1, 2, 4, 6, 12 months
  4. symptom palliation
  5. complication
  6. long-term (> 6 months) effect on cardiac function

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132613

Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan, 444-0011
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
Kyushu University Hospital
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
Gifu Municipal Hospital
Gifu,Kashima-cho,7-1, Gifu, Japan, 500-8323
Gunma Prefectural Cancer Center
Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan, 373-8550
National Nishigunma Hospital
Shibukawa,Kanai,2854, Gunma, Japan, 377-8511
National Hospital Organization, Dohoku National Hospital
Asahikawa,Hanasaki,7-4048, Hokkaido, Japan, 070-8644
National Hospital Organization Hokkaido Cancer Center
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan, 003-0804
Kobe City General Hospital
Kobe,Chuo-ku,Minatojimanakamachi,4-6, Hyogo, Japan, 650-0046
Hyogo College of Medicine
Nishinomiya,Mukogawa-cho,1-1, Hyogo, Japan, 663-8501
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan, 309-1793
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
Yokohama Mucipical Citizen's Hospital
Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan, 240-8555
Kumamoto Regional Medical Center Hospital
Kumamoto,Honjo,5-16-10, Kumamoto, Japan, 860-0811
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-8574
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino,Habikino,3-7-1, Osaka, Japan, 583-8588
Rinku General Medical Center
Izumisano,rinku-ohrai-kita,2-23, Osaka, Japan, 598-0048
Graduate School of Medicine, Osaka City University
Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, Japan, 545-0051
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan, 589-8511
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai,Nagasone,1180, Osaka, Japan, 591-8555
National Hospital Organization Toneyama National Hospital
Toyonaka,Toneyama,5-1-1, Osaka, Japan, 560-8552
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, Japan, 320-0834
National Cancer Center Hospital
Chuo-ku,Tsukiji, 5-1-1, Tokyo, Japan, 104-0045
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
International Medical Center of Japan
Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan, 162-8655
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, Japan, 990-2292
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Tomohide Tamura, MD National Cancer Center Hospital

Additional Information:
Responsible Party: Tomohide Tamura , MD, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00132613     History of Changes
Other Study ID Numbers: JCOG9811
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Japan Clinical Oncology Group:
pulmonary neoplasm
malignant pericardial effusion
pericardial drainage
randomized trial
intrapericardial instillation

Additional relevant MeSH terms:
Pericardial Effusion
Heart Diseases
Cardiovascular Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents