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)
N/A
75 Years
Both
Malignant Pericardial Effusion
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Survival without pericardial effusion at 2 months
Principal Investigator
Tomohide Tamura, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Center Hospital
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
JCOG9811
NCT ID:
NCT00132613
Start Date:
August 1999
Completion Date:
November 2006
Related Keywords:
- Malignant Pericardial Effusion
- pulmonary neoplasm
- malignant pericardial effusion
- pericardial drainage
- randomized trial
- bleomycin
- intrapericardial instillation
- Pericardial Effusion
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