UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000147 |
|---|---|
| Receipt number | R000000210 |
| Scientific Title | A Randomized phase II study of docetaxel versus weekly carboplatin and CPT-11 for previously treated Non-Small cell lung cancer |
| Date of disclosure of the study information | 2005/09/09 |
| Last modified on | 2008/05/28 10:36:29 |
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Basic information
Public title
A Randomized phase II study of docetaxel versus weekly
carboplatin and CPT-11
for previously treated Non-Small cell lung cancer
Acronym
A Randomized phase II study of docetaxel versus weekly
carboplatin and CPT-11
for previously treated Non-Small cell lung cancer
Scientific Title
A Randomized phase II study of docetaxel versus weekly
carboplatin and CPT-11
for previously treated Non-Small cell lung cancer
Scientific Title:Acronym
A Randomized phase II study of docetaxel versus weekly
carboplatin and CPT-11
for previously treated Non-Small cell lung cancer
Region
| Japan |
Condition
Condition
second line chemotherapy for Non-Small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of carboplatin/irinotecan combination to docetaxel
as second line chemotherapy for non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Primary endpoint:Response rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
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 combination
Interventions/Control_2
docetaxel
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
non-small cell lung cancer
stage 3B or 4
life expectancy at least 3 month
age 75 or younger
PS 0-2
Adequate renal, liver and bone marrow function
PaO2 65 torr or more
Key exclusion criteria
patient who received docetaxel or irinotecan
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Okishio |
Organization
National Hospital Organization Kinki-chuo chest medical center
Division name
Respiratory Medicine
Zip code
Address
1180 Nagasone Sakai, JAPAN
TEL
072-250-4034
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoichi Okishio |
Organization
National Hospital Organization Kinki-chuo chest medical center
Division name
Respiratory Medicine
Zip code
Address
1180 Nagasone Sakai, JAPAN
TEL
072-250-4034
Homepage URL
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
| 2005 | Year | 09 | 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
| 1997 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1997 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 1999 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 1999 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 1999 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 1999 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 09 | Day |
Last modified on
| 2008 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000210
