Status:
COMPLETED
Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Malignant Pericardial Effusion
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE3
Brief 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 effusio...
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 unpl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00132613
Start Date
August 1 1999
End Date
November 1 2006
Last Update
September 22 2016
Active Locations (31)
Enter a location and click search to find clinical trials sorted by distance.
1
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan, 464-8681
2
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, Japan, 444-0011
3
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
4
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007