UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002617 |
|---|---|
| Receipt number | 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 18:35:25 |
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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
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
akinoue@idac.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001507
