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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002617
Receipt No. R000001507
Scientific Title Randomized PhaseII study of amrubicin vs platinum-doublet re-challenge for small cell lung cancer with sensitive relapse
Date of disclosure of the study information 2010/03/31
Last modified on 2015/10/13

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Basic information
Public title Randomized PhaseII study of amrubicin vs platinum-doublet re-challenge for small cell lung cancer with sensitive relapse
Acronym AMR vs Re-Platinum for Sensitive Relapsed SCLC
Scientific Title Randomized PhaseII study of amrubicin vs platinum-doublet re-challenge for small cell lung cancer with sensitive relapse
Scientific Title:Acronym AMR vs Re-Platinum for Sensitive Relapsed SCLC
Region
Japan

Condition
Condition Small-Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of amrubicin with re-challange of platinum-doublet for sensitive relapased small-cell lung cancer
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 amrubicin
Interventions/Control_2 Re-challange of platinum-doublet
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 Sensitive relapased SCLC after platinum-based chemotherapy
ECOG performance status 0-2
Adequate organ function
With mesurable lesion
With written informed concent
Key exclusion criteria Pre-treated with amrubicin
With severe co-morbidities
With symptomatic brain metastasis
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Inoue
Organization Tohoku University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-1, Seiryomachi, Aobaku, Sendai
TEL +81-22-717-8539
Email akinoue@idac.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Inoue
Organization Tohoku University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-1, Seiryocho, Aobaku, Sendai
TEL +81-22-717-8539
Homepage URL
Email akinoue@idac.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Tohoku University Hospital
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
2010 Year 03 Month 31 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
2007 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2011 Year 10 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
2015 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001507

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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