UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Study of TS-1 with Patient-Reported Outcome(PRO) Evaluation in Elderly Patients with Advanced NSCLC
Title of the study (Brief title)	STEP Clinical Study
Region	Japan

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

Objectives
Narrative objectives1	To assess the efficacy and safety of TS-1 in elderly non-small cell lung cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Disease control rate
Key secondary outcomes	Progression free survival,Overall survival,Patient-Reported Outcome(PRO),Adverse events

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	TS-1:60mg/m2/day-80mg/m2/day
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Japanese 2)Histologically or cytologically Proven non-small cell lung cancer 3)Stage IIIB with no induction radiation therapy,or Stage IV 4)Age range older than 75 5)No previous chemotherapy surgery or radiotherapy 6)Measurable by RECIST criteria 7)Adequate bone narrow,liver, and renal functions Hb:over9.0g/dl WBC:4000-12000mm3 Neutro:over2000mm3 PLT:over100000/mm3 T-Bil:underNUMx2 AST,ALT:under100IU Ccr:over40ml/min PaO2:over60mmHg 8)ECOG Performance status of 0-2 9)Life expectancy of 12 weeks or more 10)Nomal EKG 11)Written informed concent
Key exclusion criteria	1)History of severe allergy 2)Received surgery or radiotherapy to primary region 3)Use of other clinical trial drugs or phenytoin warfarin or flucytosine 4)Serious infection,SIADH,vena cava superior syndrome 5)Serious medical complications 6)Massive pleural effusion,ascites and penicardial effusion requires drainage 7)Symptomatic brain metastasis 8)Require radiotherapy to primary region 9)Concomitant malignancy 10)Intention to be pregnant in the future 11)Other clinical difficulties to this study
Target sample size	40

Research contact person
Name of lead principal investigator	Yasuhiko Nishioka
Organization	Institute of Health Biosciences,The University of Tokushima Graduate School
Division name	Department of Respiratory Medicine & Rheumatology
Address	3-18-15 Kuramoto-cho,Tokushima, Tokushima 770-8503, Japan
TEL	088-633-7127
Email	yasuhiko@tokushima-u.ac.jp

Public contact
Name of contact person	Hisatsugu Goto
Organization	Institute of Health Biosciences,The University of Tokushima Graduate School
Division name	Department of Respiratory Medicine & Rheumatology
Address	3-18-15 Kuramoto-cho, Tokushima, Tokushima 770-8503, Japan
TEL	088-633-7127
Homepage URL
Email	hgoto@tokushima-u.ac.jp

Sponsor
Institute	Department of Respiratory Medicine & Rheumatology, Institute of Health Biosciences, The University of Tokushima Graduate School
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	2009 Year 06 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 04 Month 27 Day
Anticipated trial start date	2009 Year 07 Month 01 Day
Last follow-up date	2013 Year 05 Month 01 Day
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	2009 Year 06 Month 03 Day
Last modified on	2016 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002487