Clinical trial NCT00132613: Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Pericardial Effusion
Keywords: pulmonary neoplasm
malignant pericardial effusion
pericardial drainage
randomized trial
bleomycin
intrapericardial instillation
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-08-22
Enrollment: 80
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 effusion.

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 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

Primary outcomes:
measure: Survival without pericardial effusion at 2 months
Secondary outcomes:
measure: Successful extubation of pericardial drainage tube
measure: time to extubation
measure: survival without pericardial effusion at 1, 2, 4, 6, 12 months
measure: symptom palliation
measure: complication
measure: long-term (> 6 months) effect on cardiac function
Other outcomes:
Locations:
city: Nagoya,Chikusa-ku,Kanokoden,1-1
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Okazaki,Kake-machi,Kuriyado,18
country: Japan
facility: Aichi Cancer Center,Aichi Hospital
state: Aichi
city: Kashiwa,Kashiwanoha,6-5-1
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Fukuoka,Higashi-ku,Maidashi,3-1-1
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Gifu,Kashima-cho,7-1
country: Japan
facility: Gifu Municipal Hospital
state: Gifu
city: Ota,Takabayashi-nishi-cho,617-1
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Shibukawa,Kanai,2854
country: Japan
facility: National Nishigunma Hospital
state: Gunma
city: Asahikawa,Hanasaki,7-4048
country: Japan
facility: National Hospital Organization, Dohoku National Hospital
state: Hokkaido
city: Sapporo,Shiroishi-ku,Kikusui,4-2-3-54
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Kobe,Chuo-ku,Minatojimanakamachi,4-6
country: Japan
facility: Kobe City General Hospital
state: Hyogo
city: Nishinomiya,Mukogawa-cho,1-1
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Nishi-ibarakigun,Tomobemachi,Koibuchi,6528
country: Japan
facility: Ibaraki Kenritsu Chuo Hospital & Cancer Center
state: Ibaraki
city: Yokohama,Asahi-ku,Nakao,1-1-2
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Yokohama,Hodogaya-ku,Okazawa-cho,56
country: Japan
facility: Yokohama Mucipical Citizen's Hospital
state: Kanagawa
city: Kumamoto,Honjo,5-16-10
country: Japan
facility: Kumamoto Regional Medical Center Hospital
state: Kumamoto
city: Sendai,Aoba-ku,Seiryo-machi,1-1
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Niigata,Kawagishi-cho,2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Habikino,Habikino,3-7-1
country: Japan
facility: Osaka Prefectural Medical Center for Respiratory and Allergic Disease
state: Osaka
city: Izumisano,rinku-ohrai-kita,2-23
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Osaka,Abeno-ku,Asahi-machi,1-5-7
country: Japan
facility: Graduate School of Medicine, Osaka City University
state: Osaka
city: Osaka,Higashinari-ku,Nakamichi,1-3-3
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka
city: Osaka-Sayama,Ohno-higashi,377-2
country: Japan
facility: Kinki University School of Medicine
state: Osaka
city: Sakai,Nagasone,1180
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
state: Osaka
city: Toyonaka,Toneyama,5-1-1
country: Japan
facility: National Hospital Organization Toneyama National Hospital
state: Osaka
city: Kita-adachi,Ina,Komuro,818
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Utsunomiya,Yohnan,4-9-13
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Chuo-ku,Tsukiji, 5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku,Ariake,3-10-6
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Shinjuku-ku,Toyama,1-21-1
country: Japan
facility: International Medical Center of Japan
state: Tokyo
city: Yamagata,Aoyagi,1800
country: Japan
facility: Yamagata Prefectural Central Hospital
state: Yamagata
Study officials:
affiliation: National Cancer Center Hospital
name: Tomohide Tamura, MD
role: STUDY_CHAIR
References: