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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

August 19, 2005
February 29, 2008
August 1999
November 2006   (final data collection date for primary outcome measure)
Survival without pericardial effusion at 2 months
Same as current
Complete list of historical versions of study NCT00132613 on ClinicalTrials.gov Archive Site
  • 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
  • Successful extubation of pericardial drainage tube
  • time to extubation
  • survival without pericardial effusion at 1,2,4,6,12months
  • symptom palliation
  • complication
  • long-term (>6months) effect on cardiac function
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Pericardial Effusion
  • Procedure: Observation alone after pericardial drainage
  • Drug: Pericardial instillation of bleomycin after drainage
  • No Intervention: 1
    Procedure/Surgery: Observation alone after pericardial drainage
    Intervention: Procedure: Observation alone after pericardial drainage
  • Experimental: 2
    Drug: Pericardial instillation of bleomycin after drainage
    Intervention: Drug: Pericardial instillation of bleomycin after drainage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00132613
JCOG9811, C000000030
Yes
Tomohide Tamura , MD, Japan Clinical Oncology Group
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Tomohide Tamura, MD National Cancer Center Hospital
Japan Clinical Oncology Group
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP