UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II trial comparing amrubicine/irinotecan with cisplatin/irinotecan in patients with extensive-stage small-cell lung cancer: (JMTO LC 08-01)
Acronym	Randomized phase II trial comparing amrubicine/irinotecan with cisplatin/irinotecan in patients with ED-SCLC: (JMTO LC 08-01)
Scientific Title	Randomized phase II trial comparing amrubicine/irinotecan with cisplatin/irinotecan in patients with extensive-stage small-cell lung cancer: (JMTO LC 08-01)
Scientific Title:Acronym	Randomized phase II trial comparing amrubicine/irinotecan with cisplatin/irinotecan in patients with ED-SCLC: (JMTO LC 08-01)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of amrubicine and irinotecan combination therapy for chemonaive patients with ED-SCLC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	overall survival (1-year survival rate)
Key secondary outcomes	progression free survival response rate safety (incidence of an adverse event)

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	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 amrubicine on day 1 and irinotecan on days 1 and 8. Courses repeat every 3 weeks.
Interventions/Control_2	B:Patients receive cisplatin on day 1 and irinotecan on days 1, 8, and 15. Courses repeat every 4 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) histologically or cytologically proven small-cell lung cancer 2) extensive-stage small-cell lung cancer or limited-stage small-cell lung cancer with malignant pleural or pericardial effusion 3) no prior chemotherapy 4) performance status of 0 to 2 5) predicted life expectancy of 3 months 6) patients who has received palliative radiotherapy for brain or bone metastases can be included 7) adequate organ functions 8) measurable or unmeasurable disease 9) age 20 years or older 10) written informed consent
Key exclusion criteria	1)uncontrollable pleural, pericardial effusion or ascites 2)uncontrolled heart disease 3)uncontrolled diabetes mellitus 4)active infection 5)radiotherapy including pulmonary field 6)interstitial pneumonia/active lung fibrosis on chest x-ray 7)patients who has been taking steroid or immunosuppressant for any other disease 8)watery diarrhea, intestinal paralysis or obstruction 9)history of severe drug allergy 10)active concomitant malignancy 11)pregnant or lactating woman 12)patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroshige Yoshioka
Organization	Kurashiki Central Hospital
Division name	Department of Respiratory Medicine
Zip code
Address	1-1-1, Miwa, Kurashiki, Okayama 710-8602, Japan
TEL	086-422-0210
Email	hirotin@kchnet.or.jp

Public contact
1st name of contact person	1st name Middle name Last name Saori Kato
Organization	The Japan-multinational Trial Organization
Division name	The Japan-multinational Trial Organization datacenter
Zip code
Address	460-0002 P-A Bldg. 3F,2-14-10 Marunouchi,Naka-ku, Nagoya,Aichi, Japan
TEL	052-218-3301
Homepage URL
Email	jmto-adm@jmto.org

Sponsor
Institute	The Japan-multinational Trial Organization
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	倉敷中央病院（岡山県）、先端医療センター（兵庫県）、神戸市立医療センター中央市民病院（兵庫県）、京都大学医学部附属病院（京都府）、近畿中央胸部疾患センター（大阪府）、大阪警察病院（大阪府）、京都桂病院（京都府）、藤沢市民病院（神奈川県）、広島市民病院（広島県）、滋賀県立成人病センター（滋賀県）、一宮西病院（愛知県）、大手前病院（大阪府）

Other administrative information
Date of disclosure of the study information	2008 Year 07 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	2008 Year 06 Month 25 Day
Date of IRB	2008 Year 05 Month 16 Day
Anticipated trial start date	2008 Year 07 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2008 Year 07 Month 13 Day
Last modified on	2019 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001518