UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002616 |
|---|---|
| Receipt number | R000001501 |
| Scientific Title | Randomized Phase II Trial Comparing Docetaxel with weekly Paclitaxel and Carboplatin in Elderly Patients with Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2010/03/31 |
| Last modified on | 2014/04/13 08:56:46 |
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Basic information
Public title
Randomized Phase II Trial Comparing Docetaxel with weekly Paclitaxel and Carboplatin in Elderly Patients with Non-Small Cell Lung Cancer
Acronym
DOC vs wPTX+CBDCA in Elderly NSCLC
Scientific Title
Randomized Phase II Trial Comparing Docetaxel with weekly Paclitaxel and Carboplatin in Elderly Patients with Non-Small Cell Lung Cancer
Scientific Title:Acronym
DOC vs wPTX+CBDCA in Elderly NSCLC
Region
| Japan |
Condition
Condition
Non-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 docetaxel alone with those of weekly paclitaxel combined with carboplatin in elderly patients with non-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
Docetaxel alone
Interventions/Control_2
Weekly paclitaxel and carboplatin
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-small cell lung cancer
Chemotherapy-naive
Clinical Stage IIIB, IV, or post-operative reccurence
ECOG performance status 0,1
with mesurable lesion
with adequate organ function
with written informed concent
Key exclusion criteria
With severe co-morbidities
With symptomatic brain metastasis
Pregnant female patient
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Maemondo |
Organization
Miyagi Cancer Center
Division name
Department of Respiratory Medicine
Zip code
Address
47-1, Nodayama, Medeshimashiote, Natori
TEL
+81-22-717-8539
maemondo-ma693@aioros.ocn.ne.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
| 2008 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | 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
| 2014 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001501
