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

Primary Purpose

Malignant Pericardial Effusion

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Observation alone after pericardial drainage
Pericardial instillation of bleomycin after drainage
Sponsored by
Japan Clinical Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pericardial Effusion focused on measuring pulmonary neoplasm, malignant pericardial effusion, pericardial drainage, randomized trial, bleomycin, intrapericardial instillation

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aichi Cancer Center Hospital
  • Aichi Cancer Center,Aichi Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • Kyushu University Hospital
  • Gifu Municipal Hospital
  • Gunma Prefectural Cancer Center
  • National Nishigunma Hospital
  • National Hospital Organization, Dohoku National Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • Kobe City General Hospital
  • Hyogo College of Medicine
  • Ibaraki Kenritsu Chuo Hospital & Cancer Center
  • Kanagawa Cancer Center
  • Yokohama Mucipical Citizen's Hospital
  • Kumamoto Regional Medical Center Hospital
  • Tohoku University Hospital
  • Niigata Cancer Center Hospital
  • Osaka Prefectural Medical Center for Respiratory and Allergic Disease
  • Rinku General Medical Center
  • Graduate School of Medicine, Osaka City University
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Kinki University School of Medicine
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • National Hospital Organization Toneyama National Hospital
  • Saitama Cancer Center
  • Tochigi Cancer Center
  • National Cancer Center Hospital
  • Cancer Institute Hospital
  • International Medical Center of Japan
  • Yamagata Prefectural Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Procedure/Surgery: Observation alone after pericardial drainage

Drug: Pericardial instillation of bleomycin after drainage

Outcomes

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

Full Information

First Posted
August 19, 2005
Last Updated
September 20, 2016
Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00132613
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pericardial Effusion
Keywords
pulmonary neoplasm, malignant pericardial effusion, pericardial drainage, randomized trial, bleomycin, intrapericardial instillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Observation alone after pericardial drainage
Arm Title
2
Arm Type
Experimental
Arm Description
Drug: Pericardial instillation of bleomycin after drainage
Intervention Type
Procedure
Intervention Name(s)
Observation alone after pericardial drainage
Intervention Type
Drug
Intervention Name(s)
Pericardial instillation of bleomycin after drainage
Primary Outcome Measure Information:
Title
Survival without pericardial effusion at 2 months
Secondary Outcome Measure Information:
Title
Successful extubation of pericardial drainage tube
Title
time to extubation
Title
survival without pericardial effusion at 1, 2, 4, 6, 12 months
Title
symptom palliation
Title
complication
Title
long-term (> 6 months) effect on cardiac function

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomohide Tamura, MD
Organizational Affiliation
National Cancer Center Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Nagoya,Chikusa-ku,Kanokoden,1-1
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Aichi Cancer Center,Aichi Hospital
City
Okazaki,Kake-machi,Kuriyado,18
State/Province
Aichi
ZIP/Postal Code
444-0011
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa,Kashiwanoha,6-5-1
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama,Horinouchi,13
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka,Higashi-ku,Maidashi,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu,Kashima-cho,7-1
State/Province
Gifu
ZIP/Postal Code
500-8323
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Ota,Takabayashi-nishi-cho,617-1
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
National Nishigunma Hospital
City
Shibukawa,Kanai,2854
State/Province
Gunma
ZIP/Postal Code
377-8511
Country
Japan
Facility Name
National Hospital Organization, Dohoku National Hospital
City
Asahikawa,Hanasaki,7-4048
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Kobe City General Hospital
City
Kobe,Chuo-ku,Minatojimanakamachi,4-6
State/Province
Hyogo
ZIP/Postal Code
650-0046
Country
Japan
Facility Name
Hyogo College of Medicine
City
Nishinomiya,Mukogawa-cho,1-1
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Ibaraki Kenritsu Chuo Hospital & Cancer Center
City
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama,Asahi-ku,Nakao,1-1-2
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Yokohama Mucipical Citizen's Hospital
City
Yokohama,Hodogaya-ku,Okazawa-cho,56
State/Province
Kanagawa
ZIP/Postal Code
240-8555
Country
Japan
Facility Name
Kumamoto Regional Medical Center Hospital
City
Kumamoto,Honjo,5-16-10
State/Province
Kumamoto
ZIP/Postal Code
860-0811
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai,Aoba-ku,Seiryo-machi,1-1
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata,Kawagishi-cho,2-15-3
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
City
Habikino,Habikino,3-7-1
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumisano,rinku-ohrai-kita,2-23
State/Province
Osaka
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
Graduate School of Medicine, Osaka City University
City
Osaka,Abeno-ku,Asahi-machi,1-5-7
State/Province
Osaka
ZIP/Postal Code
545-0051
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka,Higashinari-ku,Nakamichi,1-3-3
State/Province
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Kinki University School of Medicine
City
Osaka-Sayama,Ohno-higashi,377-2
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Sakai,Nagasone,1180
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
National Hospital Organization Toneyama National Hospital
City
Toyonaka,Toneyama,5-1-1
State/Province
Osaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi,Ina,Komuro,818
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya,Yohnan,4-9-13
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku,Tsukiji, 5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Cancer Institute Hospital
City
Koto-ku,Ariake,3-10-6
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
International Medical Center of Japan
City
Shinjuku-ku,Toyama,1-21-1
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata,Aoyagi,1800
State/Province
Yamagata
ZIP/Postal Code
990-2292
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.jcog.jp/
Description
Related Info

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

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