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

Information source: Japan Clinical Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malignant Pericardial Effusion

Intervention: Observation alone after pericardial drainage (Procedure); Pericardial instillation of bleomycin after drainage (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Japan Clinical Oncology Group

Official(s) and/or principal investigator(s):
Tomohide Tamura, MD, Study Chair, Affiliation: National Cancer Center Hospital

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Survival without pericardial effusion at 2 months

Secondary outcome:

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

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

Minimum age: N/A. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Aichi Cancer Center Hospital, 1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi 464-8681, Japan

Aichi Cancer Center,Aichi Hospital, 18,Kuriyado,Kake-machi,Okazaki, Aichi 444-0011, Japan

National Cancer Center Hospital East, 6-5-1,Kashiwanoha,Kashiwa, Chiba 277-8577, Japan

National Hospital Organization Shikoku Cancer Center, 13,Horinouchi,Matsuyama, Ehime 790-0007, Japan

Kyushu University Hospital, 3-1-1,Maidashi,Higashi-ku,Fukuoka, Fukuoka 812-8582, Japan

Gifu Municipal Hospital, 7-1,Kashima-cho,Gifu, Gifu 500-8323, Japan

National Nishigunma Hospital, 2854 Kanai,Shibukawa, Gunma 377-8511, Japan

Gunma Prefectural Cancer Center, 617-1,Takabayashi-nishi-cho,Ota, Gunma 373-8550, Japan

National Hospital Organization Hokkaido Cancer Center, 4-2-3-54,Kikusui,Shiroishi-ku,Sapporo, Hokkaido 003-0804, Japan

National Hospital Organization, Dohoku National Hospital, 7-4048,Hanasaki,Asahikawa, Hokkaido 070-8644, Japan

Hyogo College of Medicine, 1-1,Mukogawa-cho,Nishinomiya, Hyogo 663-8501, Japan

Kobe City General Hospital, 4-6,Minatojimanakamachi,Chuo-ku,Kobe, Hyogo 650-0046, Japan

Ibaraki Kenritsu Chuo Hospital & Cancer Center, 6528 Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki 309-1793, Japan

Kanagawa Cancer Center, 1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa 241-0815, Japan

Yokohama Mucipical Citizen's Hospital, 56,Okazawa-cho,Hodogaya-ku,Yokohama, Kanagawa 240-8555, Japan

Kumamoto Regional Medical Center Hospital, 5-16-10,Honjo,Kumamoto, Kumamoto 860-0811, Japan

Tohoku University Hospital, 1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi 980-8574, Japan

Niigata Cancer Center Hospital, 2-15-3,Kawagishi-cho,Niigata, Niigata 951-8566, Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka 537-8511, Japan

Graduate School of Medicine, Osaka City University, 1-5-7,Asahi-machi,Abeno-ku,Osaka, Osaka 545-0051, Japan

National Hospital Organization Kinki-Chuo Chest Medical Center, 1180 Nagasone,Sakai, Osaka 591-8555, Japan

Rinku General Medical Center, 2-23,rinku-ohrai-kita,Izumisano, Osaka 598-0048, Japan

Osaka Prefectural Medical Center for Respiratory and Allergic Disease, 3-7-1,Habikino,Habikino, Osaka 583-8588, Japan

Kinki University School of Medicine, 377-2,Ohno-higashi,Osaka-Sayama, Osaka 589-8511, Japan

National Hospital Organization Toneyama National Hospital, 5-1-1,Toneyama,Toyonaka, Osaka 560-8552, Japan

Saitama Cancer Center, 818,Komuro,Ina,Kita-adachi, Saitama 362-0806, Japan

Tochigi Cancer Center, 4-9-13,Yohnan,Utsunomiya, Tochigi 320-0834, Japan

International Medical Center of Japan, 1-21-1,Toyama,Shinjuku-ku, Tokyo 162-8655, Japan

Cancer Institute Hospital, 3-10-6,Ariake,Koto-ku, Tokyo 135-8550, Japan

National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

Yamagata Prefectural Central Hospital, 1800,Aoyagi,Yamagata, Yamagata 990-2292, Japan

Additional Information

Starting date: August 1999
Last updated: February 29, 2008

Page last updated: August 20, 2015

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