Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion - Full Text View

Sponsors and Collaborators:	Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00132613

Purpose

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.

Condition	Intervention	Phase
Malignant Pericardial Effusion	Procedure: Observation alone after pericardial drainage Drug: Pericardial instillation of bleomycin after drainage	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Bleomycin Bleomycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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)

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:

Survival without pericardial effusion at 2 months

Secondary Outcome Measures:

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

Enrollment:	80
Study Start Date:	August 1999
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Procedure/Surgery: Observation alone after pericardial drainage	Procedure: Observation alone after pericardial drainage
2: Experimental Drug: Pericardial instillation of bleomycin after drainage	Drug: Pericardial instillation of bleomycin after drainage

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 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.

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132613

Show 31 Study Locations

Sponsors and Collaborators

Japan Clinical Oncology Group

Japanese Ministry of Health, Labor and Welfare

Investigators

Study Chair:

Tomohide Tamura, MD

National Cancer Center Hospital

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Japan Clinical Oncology Group ( Tomohide Tamura , MD )
Study ID Numbers:	JCOG9811, C000000030
Study First Received:	August 19, 2005
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00132613
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:

pulmonary neoplasm
malignant pericardial effusion
pericardial drainage

randomized trial
bleomycin
intrapericardial instillation

Study placed in the following topic categories:

Heart Diseases
Lung Neoplasms
Pericardial Effusion
Bleomycin

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Cardiovascular Diseases
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009