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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002616
Receipt No. 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

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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
Email 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
Email akinoue@idac.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001501

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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