UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001115 |
|---|---|
| Receipt number | R000001350 |
| Scientific Title | a phase II trial of amrubicin and carboplatin for patients with extensive stage small cell lung cancer |
| Date of disclosure of the study information | 2008/04/09 |
| Last modified on | 2014/03/04 12:52:16 |
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Basic information
Public title
a phase II trial of amrubicin and carboplatin for patients with extensive stage small cell lung cancer
Acronym
PII of AMR/CBDCA for EDSCLC
Scientific Title
a phase II trial of amrubicin and carboplatin for patients with extensive stage small cell lung cancer
Scientific Title:Acronym
PII of AMR/CBDCA for EDSCLC
Region
| Japan |
Condition
Condition
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 amurubicin and carboplatin for extensive stage small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression free survival, overall survival, toxicity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
amurubicin+carboplatin
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. histological confiremd small cell lung cancer
2. extensive stage
3. chemotherapy naive
4. expectable 12 week survival
5. have measurable lesion
6. 75 years or younger
7. performance status 0, 1, 2 for Eastern Cooperative Oncology Group (ECOG)
8. adequate organ function
9. written informed consent
Key exclusion criteria
1. severe cardiac effusion
2. severe supra vena cava syndrome
3. severe complication (angina pectoris, myocardial infarction, heart failure, diabetes, hypertension, infection, interstitial pneumonia)
4. active other cancer
5. pregnancy women
6. need radiotherapy for brain metastasis
7. limited stage small cell lung cancer
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Fukuda |
Organization
Nagasaki Thoracic Oncology Group
Division name
Nagasaki Municipal Hospital
Zip code
Address
6-39 Shinchi-machi, Nagasaki 850-8555, Japan
TEL
095-822-3251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Fukuda |
Organization
Nagasaki Municipal Hospital
Division name
Internal Medicine
Zip code
Address
6-39 Shinchi-machi, Nagasaki 850-8555, Japan
TEL
090-822-3251
Homepage URL
http://www1.city.nagasaki.nagasaki.jp/shibyo/index.html
mifukuda258@nifty.com
Sponsor or person
Institute
Nagasaki Thoracic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Thoracic Oncology Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2008 | Year | 04 | Month | 09 | 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 | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 09 | Day |
Last modified on
| 2014 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001350
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
