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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000030
Receipt No. R000000064
Scientific 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).
Date of disclosure of the study information 2005/07/28
Last modified on 2014/08/13

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Basic information
Public 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).
Acronym 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).
Scientific 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).
Scientific Title:Acronym 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).
Region
Japan

Condition
Condition Malignant pericardial effusion
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of pericardial instillation of bleomycin as sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial effusion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Survival without pericardial effusion at 2 months
Key secondary outcomes Succesful extubation of pericardial drainage tube, time to extubation, survival without pericardial effusion at 1,2,4,6,12months, symptom palliation, complication, long-term (>6months) effect on cardiac function.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Observation alone after pericardial drainage
Interventions/Control_2 Percardial instillation of bleomycin after pericardial drainage
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)pathologically documented lung cancer
2)clinically stable condition after pericardial drainage for malignant pericardial effusion (not necessary to be documented by cytology)
3)expected to live 6 weeks or longer
4)sufficient organ function
5)signed informed consent
Key exclusion criteria 1)Myocardial infarction or unstable angina within 3 months
2)constricitive pericarditis
3)active pneumonitis
4)severe infection or DIC
5)other severe co-morbidity which could not be relieved with pericardial drainage
6)chemotherapy-naive small cell lung cancer
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohide Tamura, M.D.
Organization National Cancer Center Hospital
Division name Medical Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Kunitoh, M.D.
Organization JCOG9811 Coordinating Office
Division name Medical Oncology Division, National Cancer Center Hospital
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00132613
Org. issuing International ID_1 ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立病院機構道北病院 (北海道)
国立病院機構北海道がんセンター(北海道)
旭川医科大学 (北海道)
東北大学病院 (宮城県)
山形県立中央病院 (山形県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
国立病院機構西群馬病院 (群馬県)
群馬県立がんセンター(群馬県)
埼玉県立がんセンター(埼玉県)
国立がんセンター東病院 (千葉県)
国立がんセンター中央病院 (東京都)
国立国際医療センター(東京都)
東京慈恵会医科大学青戸病院 (東京都)
癌研究会有明病院 (東京都)
都立駒込病院 (東京都)
神奈川県立がんセンター(神奈川県)
横浜市立市民病院(神奈川県)
新潟県立がんセンター新潟病院 (新潟県)
岐阜市民病院 (岐阜県)
愛知県がんセンター中央病院 (愛知県)
国立病院機構名古屋医療センター(愛知県)
愛知県がんセンター愛知病院 (愛知県)
大阪市立大学大学院医学研究科(大阪府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
大阪府立病院機構大阪府立呼吸器・アレルギー医療センター(大阪府)
国立病院機構近畿中央胸部疾患センター(大阪府)
国立病院機構刀根山病院 (大阪府)
りんくう総合医療センター市立泉佐野病院 (大阪府)
神戸市立中央市民病院 (兵庫県)
兵庫医科大学 (兵庫県)
国立病院機構四国がんセンター(愛媛県)
九州大学病院 (福岡県)
長崎大学医学部・歯学部附属病院 (長崎県)
熊本地域医療センター(熊本県)

Other administrative information
Date of disclosure of the study information
2005 Year 07 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/19156149
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
1999 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
1999 Year 08 Month 01 Day
Last follow-up date
2006 Year 11 Month 01 Day
Date of closure to data entry
2006 Year 12 Month 01 Day
Date trial data considered complete
2006 Year 12 Month 01 Day
Date analysis concluded
2006 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 07 Month 28 Day
Last modified on
2014 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000064

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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