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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00132613
First received: August 19, 2005
Last updated: February 29, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Malignant Pericardial Effusion
Procedure: Observation alone after pericardial drainage
Drug: Pericardial instillation of bleomycin after drainage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • Survival without pericardial effusion at 2 months

Secondary Outcome Measures:
  • 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

Enrollment: 80
Study Start Date: August 1999
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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

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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132613

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

Additional Information:
No publications provided

Responsible Party: Tomohide Tamura , MD, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00132613     History of Changes
Other Study ID Numbers: JCOG9811, C000000030
Study First Received: August 19, 2005
Last Updated: February 29, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Pericardial Effusion
Heart Diseases
Cardiovascular Diseases
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014