UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008970 |
|---|---|
| Receipt number | R000010520 |
| Scientific Title | Randomized phase II trial comparing carboplatin plus irinotecan with carboplatin plus amrubicine for extensive disease small-cell lung cancer |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2015/03/24 12:49:19 |
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Basic information
Public title
Randomized phase II trial comparing carboplatin plus irinotecan with carboplatin plus amrubicine 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 trial comparing carboplatin plus irinotecan with carboplatin plus amrubicine 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
Small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of above 2 regimen for ED-SCLC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective 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 plus irinotecan
Interventions/Control_2
carboplatin plus amrubicine
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 confirmed SCLC.
2. Chemo-naive
3. Stage IIIB, IV, or post-operative relapse
4. PS0-2
5. Adequete organ functions
6. Written informed concent
Key exclusion criteria
1. Severe co-morbidities
2. Symptomatic brain metastasis
3. Not appropriate for clinical trial decided by the attending physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Morikawa |
Organization
Iwate Medical University
Division name
Division of Pulmonary Medicine, Allergy, and Rheumatology
Zip code
Address
19-1 Uchimaru, Morioka, Iwate 020-8505
TEL
+81-19-651-5111
carcinoma@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Inoue |
Organization
North-Japan lung cancer group
Division name
Office
Zip code
Address
1-1, Seiryocho, Aobaku, Sendai
TEL
+81-22-717-8539
Homepage URL
akinoue@idac.tohoku.ac.jp
Sponsor or person
Institute
North-Japan lung cancer group
Institute
Department
Personal name
Funding Source
Organization
North-Japan lung cancer group
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
| 2012 | Year | 10 | 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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 24 | Day |
Last modified on
| 2015 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010520
