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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002615
Receipt No. R000003192
Scientific Title Randomized phase II study of carboplatin plus irinotecan versus carboplatin plus amrubicin for extensive disease small cell lung cancer
Date of disclosure of the study information 2009/11/01
Last modified on 2017/04/18

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Basic information
Public title Randomized phase II study of carboplatin plus irinotecan versus carboplatin plus amrubicin for extensive disease small cell lung cancer
Acronym Randomized phase II of CBDCA+CPT vs CBDCA+AMR for ED-SCLC
Scientific Title Randomized phase II study of carboplatin plus irinotecan versus carboplatin plus amrubicin for extensive disease small cell lung cancer
Scientific Title:Acronym Randomized phase II of CBDCA+CPT vs CBDCA+AMR for ED-SCLC
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 select the better treatment for phase III trial
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 carboplatin + irinotecan
Interventions/Control_2 carboplatin + amrubicin
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. Cytologically or histologically proven small cell lung caner
2. Chemotherapy-naive extensive disease small cell lung cancer
3. With performance status 0-2
4. With appropriate organ function
5. With mesurable lesion
6. With life expectancy > 2 months
7. With written informed consent
Key exclusion criteria 1. With serirous comprications such as infection, heart disease, lung fibrosis.
2. With symptomatic brain metastasis or massive effusion
3. With active other malignancies
4. Pregnant women
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Inoue
Organization Tohoku University Hospital
Division name Respiratory medicine
Zip code
Address 1-1, Seiryomachi, Aobaku, Sendai
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization North Japan Lung Cancer Study Group
Division name Office
Zip code
Address
TEL
Homepage URL
Email akinoue@idac.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
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

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 01 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 Main results already published
Date of protocol fixation
2009 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 09 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
2009 Year 10 Month 12 Day
Last modified on
2017 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003192

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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