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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000720
Receipt No. R000000859
Scientific Title A Phase III Randomized, Multicenter Study Comparing Irinotevan and Cisplatin (IP) with Amrubicin and Cisplatin (AP) for the Treatment of Extensive-Stage Small-Cell Lung Cancer: (JCOG0509)
Date of disclosure of the study information 2007/05/22
Last modified on 2016/04/08

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Basic information
Public title A Phase III Randomized, Multicenter Study Comparing Irinotevan and Cisplatin (IP) with Amrubicin and Cisplatin (AP) for the Treatment of Extensive-Stage Small-Cell Lung Cancer: (JCOG0509)
Acronym A Phase III Randomized, Multicenter Study Comparing Irinotevan and Cisplatin (IP) with Amrubicin and Cisplatin (AP) for the Treatment of Extensive-Stage Small-Cell Lung Cancer: (JCOG0509)
Scientific Title A Phase III Randomized, Multicenter Study Comparing Irinotevan and Cisplatin (IP) with Amrubicin and Cisplatin (AP) for the Treatment of Extensive-Stage Small-Cell Lung Cancer: (JCOG0509)
Scientific Title:Acronym A Phase III Randomized, Multicenter Study Comparing Irinotevan and Cisplatin (IP) with Amrubicin and Cisplatin (AP) for the Treatment of Extensive-Stage Small-Cell Lung Cancer: (JCOG0509)
Region
Japan

Condition
Condition extensive-disease small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether combination regimen of Amrubicin plus cisplatin provides better overall survival than Irinotecan plus cisplatin in patients with previously untreated ED-SCLC
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes progression-free survival, response rate, diarrhea(Grade3/4), adverse events, QOL

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A : Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 and cisplatin IV over 60-120 minutes on day 1. Courses repeat every 4 weeks.
Interventions/Control_2 B : Patients receive Amrubicin IV in 5 minutes on days 1-3 and cisplatin IV over 60-120 minutes on day 1. Courses repeat every 3 weeks.
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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) cytologically, histologically proven small-cell lung cancer
2) extensive disease
3) age 20-70 years old
4) performance status of 0-1
5) measurable or unmeasurable disease
6) no prior chemotherapy or radiation treatment for cancer
7) adequate organ functions
8) requested a patient to answer the QOL qestionaire
9) written informed consent
Key exclusion criteria 1) active concomitant malignancy
2) severe complications related malignancy (Superior vena cava syndrome, pleural effusion that required drainage, pericarditis carcinomatous, symptomatic brain metastasis)
3) active infection
4) watery diarrhea
5) intestinal obstruction or paralysis
6) interstitial pneumonia/active lung fibrosis on chest x-ray
7) non-steroidal anti-inflammatory drug or glucocorticoid use for >50 days
8) uncontrolled diabetes mellitus,
9) uncontrolled heart disease or a history of myocardial infarction within the previous 6 months
10) psychological disease deemed unacceptable for inclusion to the study
11) pregnant or lactating women
12) active gastric and/or duodenal ulcer
Target sample size 282

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miyako Satouchi MD
Organization Hyogo Cancer Center
Division name Department of Respiratory Medicine
Zip code
Address 13-70, Kitaouji-cho, Akashi, Hyogo 673-8558, Japan
TEL 078-382-5846
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshikazu Kotani MD
Organization JCOG0509 Coordinating Office
Division name Kobe University Hospital Department of Respiratory Medicine
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL 078-382-5846
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立病院機構旭川医療センター(北海道)
国立病院機構北海道がんセンター(北海道)
KKR札幌医療センター(北海道)
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)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
がん・感染症センター都立駒込病院(東京都)
国立国際医療研究センター病院(東京都)
がん研究会有明病院(東京都)
神奈川県立病院機構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)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
愛知県がんセンター愛知病院(愛知県)
大阪市立大学医学部附属病院(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)
大阪府立病院機構大阪府立急性期・総合医療センター(大阪府)
大阪市立総合医療センター(大阪府)
神戸市立医療センター中央市民病院(兵庫県)
兵庫県立がんセンター(兵庫県)
岡山大学病院(岡山県)
国立病院機構山口宇部医療センター(山口県)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
熊本地域医療センター(熊本県)

Other administrative information
Date of disclosure of the study information
2007 Year 05 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24638015
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
2007 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2014 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 05 Month 22 Day
Last modified on
2016 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000859

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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