UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000147
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000210

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.