UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief 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)
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Miyako Satouchi MD
Organization	Hyogo Cancer Center
Division name	Department of Respiratory Medicine
Address	13-70, Kitaouji-cho, Akashi, Hyogo 673-8558, Japan
TEL	078-382-5846
Email

Public contact
Name of contact person	Yoshikazu Kotani MD
Organization	JCOG0509 Coordinating Office
Division name	Kobe University Hospital Department of Respiratory Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 04 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/24638015
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
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-bin/ctr_e/ctr_view.cgi?recptno=R000000859