UMIN-CTR Clinical Trial

Basic information
Public title	A Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Acronym	A Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Scientific Title	A Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Scientific Title:Acronym	A Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Region	Japan

Condition
Condition	Locally Advanced Non-Small Cell Lung Cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	It compares by a Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Survival
Key secondary outcomes	Response rate, TTP, Safety, Compliance

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	UFT:400mg/m2,p.o.,d1-14,d29-42 Cisplatin:80mg/m2,div,d8,36 Radiation:2Gy*5days/week,d1-40, total 60Gy A: UFT:400mg/m2,p.o.,d1-14 Cisplatin: 80mg/m2,div,d8 every 3-4weeks
Interventions/Control_2	UFT:400mg/m2,p.o.,d1-14,d29-42 Cisplatin:80mg/m2,div,d8,36 Radiation:2Gy*5days/week,d1-40, total 60Gy B: Docetaxel:60mg/m2,div,d1 every 3weeks
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	1)Histologically or cytologically confirmed NSCLC 2) Measurable or evaluable disease, No prior chemotherapy ,Stage IIIA or IIIB 3) 75 years old or less 4) P.S.(ECOG) 0-1 5)Sufficient organ functions 6)Provided written informed consent.
Key exclusion criteria	1)bronchopulmonary lymph node metastasis 2) Pleural or pericardial effusion requiring treatment 3) Concomitant malignancy 4) Serious concomitant disease 5)Apparent ineterstitial pneumonia or pulmonary fibrosis 6)Pregnant or lactation women, or women with known or suspected pregnancy. Man who wont let to pregnancy
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukito Ichinose
Organization	National Kyushu Cancer Center
Division name	National Kyushu Cancer Center
Zip code
Address	3-1-1 Notame Mimami-ku Fukuoka-shi Fukuoka Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	National Kyushu Cancer Center
Division name	Respiratory
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	2005 Year 11 Month 18 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	2003 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date	2003 Year 06 Month 01 Day
Last follow-up date	2008 Year 03 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	2005 Year 11 Month 18 Day
Last modified on	2010 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000367

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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