UMIN-CTR Clinical Trial

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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