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

Japan Clinical Oncology Group

Status and phase: Completed; Phase 3

Conditions: Malignant Pericardial Effusion

Treatments: Procedure: Observation alone after pericardial drainage; Drug: Pericardial instillation of bleomycin after drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT00132613

C000000030

JCOG9811

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

1

Active Comparator group

Description:

Procedure/Surgery: Observation alone after pericardial drainage

Treatment:

Procedure: Observation alone after pericardial drainage

2

Experimental group

Description:

Drug: Pericardial instillation of bleomycin after drainage

Treatment:

Drug: Pericardial instillation of bleomycin after drainage