UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	UFT maintenance after platinum base adjuvant chemotherapy for resected non-small lung cancer
Title of the study (Brief title)	UFT maintenance after complete resection for lung cancer
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate UFT maintenance after platinum base adjuvant chemotherapy for completely resected non-small lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Completion rate of 2-year UFT adminsitration
Key secondary outcomes	Safety, disease-free survival duration,overall survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	UFT daily for 2 years
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically proven non-small lung cancer. 2)Complete resection histologically. 3)Platinum base chemothrapy 1=< courses as prior adjuvant chemotherapy. 4)20 years old or older. 5)Performance status(ECOG)=0-2 6)WBC>=2,000 and <=12,000/mm3 Neutrophil>=1,000mm3 Platlet>=75,000/mm3 T Bil<=1.5mg/dL AST/ALT<=100 IU/L PaO2>=70mmHg 7)Written informed consent
Key exclusion criteria	1)history of Allergy to UFT 2)History of lung fibrosis or intersittial pneumonistis 3)Active infectious diseases 4)Seviour diarrhea 5)Pre-operation or history of non-platinum adjuvant chemotherapy 6)Concomitant malignancy 7)No match for includion criteria within 8 weeks after prior adjuvant chemotherpy 8)No pregnant or nursing 9)Other uncontrolled medical illness
Target sample size	50

Research contact person
Name of lead principal investigator	Shigeki Sawada
Organization	Shikoku Cancer Center
Division name	Thracic surgery
Address	190 Minamiumemotocho-Ko, Matsuyama, Ehime 791-0280, Japan
TEL	+81-89-999-1111
Email	ssawada-ths@umin.ac.jp

Public contact
Name of contact person	Shigeki Sawada
Organization	Shikoku Cancer Center
Division name	Thoracic Surgery
Address	160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture
TEL	+81-89-999-1111
Homepage URL
Email	ssawada-ths@umin.ac.jp

Sponsor
Institute	Thracic Surgery Shikoku Cancer Center
Institute
Department

Funding Source
Organization	Shikoku Cancer Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 02 Month 17 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 02 Month 17 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 02 Month 17 Day
Last modified on	2017 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003884