CompletedPhase 3

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

Japan80 participantsStarted 1999-08

Plain-language 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.

Who can participate

Age range75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Survival without pericardial effusion at 2 months

Trial details

NCT IDNCT00132613

SponsorJapan Clinical Oncology Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-11

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