UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000030 |
|---|---|
| Receipt number | 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 13:58:49 |
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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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000064
