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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000310
Receipt No. R000000400
Scientific Title Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
Date of disclosure of the study information 2006/01/23
Last modified on 2007/03/26

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Basic information
Public title Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
Acronym Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
Scientific Title Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
Scientific Title:Acronym Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
Region
Japan

Condition
Condition Non-small sell lung carcinoma (NSCLC)
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficary of the Docetaxel + Gemcitabin (DG) regimen, and to determine if it is not inferior to the Docetaxel + Cisplatin (DC) regimen.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Survival (1-year survival rate)
Toxicity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 The DC arm:
Doc(60mg/m2) day1
CDDP(80mg/m2) day1
Every 3 to 4 weeks
Interventions/Control_2 The DG arm:
Doc(60mg/m2) day8
Gem(800mg/m2) day1,8
Every 3 to 4 weeks
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically or cytologically proven NSCLC
2.Stage IIIB or IV
3.Measurable lesions by RECIST
4.No prior therapy
5.PS(ECOG) 0 or 1
6.Expected survival of more than 3 months
7.Preserved organ functions
8.Age of 20 to 75-year old
9.Written IC
Key exclusion criteria 1.Proven or suspected infections diseases
2.Interstitial pneumonia (pulmonary fibrosis) manifested with chest radiogram and symptoms
3.Uncontrolable complications of heart, liver, DM, bleeding, etc.
4.Peripheral neuropathy of grade 2 or severer
5.Pleural fluid requiring treatment
6.Pericardial fluid
7.Symptomatic brain metastasis
8.Active concomitant malignancy
9.Pregnancy, breast feeding or wish of future bearing
10.History of drug allergy
11.Myocardial infarction within 3 months
12.Requirement of emergency radiotherapy
13.Other conditions not suitable for this study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisanobu Niitani
Organization The Tokyo cooperative oncology group
Division name Chief director
Zip code
Address 1-23-2 Hamamatsu-cho Minato-ku Tokyo Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Tokyo cooperative oncology group
Division name Secretariat
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute The Tokyo cooperative oncology group
Institute
Department

Funding Source
Organization The Tokyo cooperative oncology group
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
2006 Year 01 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.jto.org/
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
2002 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2002 Year 05 Month 01 Day
Last follow-up date
2004 Year 08 Month 01 Day
Date of closure to data entry
2004 Year 09 Month 01 Day
Date trial data considered complete
2004 Year 09 Month 01 Day
Date analysis concluded
2004 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 01 Month 23 Day
Last modified on
2007 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000400

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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