Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion
This study has been completed.
Sponsor:
Japan Clinical Oncology Group
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00132613
First received: August 19, 2005
Last updated: February 29, 2008
Last verified: February 2008
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
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 |
|---|---|
|
No Intervention: 1
Procedure/Surgery: Observation alone after pericardial drainage
|
Procedure: Observation alone after pericardial drainage |
|
Experimental: 2
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
Locations
| Japan | |
| Aichi Cancer Center Hospital | |
| 1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681 | |
| Aichi Cancer Center,Aichi Hospital | |
| 18,Kuriyado,Kake-machi,Okazaki, Aichi, Japan, 444-0011 | |
| National Cancer Center Hospital East | |
| 6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577 | |
| National Hospital Organization Shikoku Cancer Center | |
| 13,Horinouchi,Matsuyama, Ehime, Japan, 790-0007 | |
| Kyushu University Hospital | |
| 3-1-1,Maidashi,Higashi-ku,Fukuoka, Fukuoka, Japan, 812-8582 | |
| Gifu Municipal Hospital | |
| 7-1,Kashima-cho,Gifu, Gifu, Japan, 500-8323 | |
| National Nishigunma Hospital | |
| 2854 Kanai,Shibukawa, Gunma, Japan, 377-8511 | |
| Gunma Prefectural Cancer Center | |
| 617-1,Takabayashi-nishi-cho,Ota, Gunma, Japan, 373-8550 | |
| National Hospital Organization Hokkaido Cancer Center | |
| 4-2-3-54,Kikusui,Shiroishi-ku,Sapporo, Hokkaido, Japan, 003-0804 | |
| National Hospital Organization, Dohoku National Hospital | |
| 7-4048,Hanasaki,Asahikawa, Hokkaido, Japan, 070-8644 | |
| Hyogo College of Medicine | |
| 1-1,Mukogawa-cho,Nishinomiya, Hyogo, Japan, 663-8501 | |
| Kobe City General Hospital | |
| 4-6,Minatojimanakamachi,Chuo-ku,Kobe, Hyogo, Japan, 650-0046 | |
| Ibaraki Kenritsu Chuo Hospital & Cancer Center | |
| 6528 Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki, Japan, 309-1793 | |
| Kanagawa Cancer Center | |
| 1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815 | |
| Yokohama Mucipical Citizen's Hospital | |
| 56,Okazawa-cho,Hodogaya-ku,Yokohama, Kanagawa, Japan, 240-8555 | |
| Kumamoto Regional Medical Center Hospital | |
| 5-16-10,Honjo,Kumamoto, Kumamoto, Japan, 860-0811 | |
| Tohoku University Hospital | |
| 1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi, Japan, 980-8574 | |
| Niigata Cancer Center Hospital | |
| 2-15-3,Kawagishi-cho,Niigata, Niigata, Japan, 951-8566 | |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | |
| 1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka, Japan, 537-8511 | |
| Graduate School of Medicine, Osaka City University | |
| 1-5-7,Asahi-machi,Abeno-ku,Osaka, Osaka, Japan, 545-0051 | |
| National Hospital Organization Kinki-Chuo Chest Medical Center | |
| 1180 Nagasone,Sakai, Osaka, Japan, 591-8555 | |
| Rinku General Medical Center | |
| 2-23,rinku-ohrai-kita,Izumisano, Osaka, Japan, 598-0048 | |
| Osaka Prefectural Medical Center for Respiratory and Allergic Disease | |
| 3-7-1,Habikino,Habikino, Osaka, Japan, 583-8588 | |
| Kinki University School of Medicine | |
| 377-2,Ohno-higashi,Osaka-Sayama, Osaka, Japan, 589-8511 | |
| National Hospital Organization Toneyama National Hospital | |
| 5-1-1,Toneyama,Toyonaka, Osaka, Japan, 560-8552 | |
| Saitama Cancer Center | |
| 818,Komuro,Ina,Kita-adachi, Saitama, Japan, 362-0806 | |
| Tochigi Cancer Center | |
| 4-9-13,Yohnan,Utsunomiya, Tochigi, Japan, 320-0834 | |
| International Medical Center of Japan | |
| 1-21-1,Toyama,Shinjuku-ku, Tokyo, Japan, 162-8655 | |
| Cancer Institute Hospital | |
| 3-10-6,Ariake,Koto-ku, Tokyo, Japan, 135-8550 | |
| National Cancer Center Hospital | |
| 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045 | |
| Yamagata Prefectural Central Hospital | |
| 1800,Aoyagi,Yamagata, Yamagata, Japan, 990-2292 | |
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
| Study Chair: | Tomohide Tamura, MD | National Cancer Center Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Tomohide Tamura , MD, Japan Clinical Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00132613 History of Changes |
| Other Study ID Numbers: | JCOG9811, C000000030 |
| Study First Received: | August 19, 2005 |
| Last Updated: | February 29, 2008 |
| 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 |
Additional relevant MeSH terms:
|
Pericardial Effusion Heart Diseases Cardiovascular Diseases Bleomycin |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013