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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002035
Receipt No. R000002487
Scientific Title Phase II Study of TS-1 with Patient-Reported Outcome(PRO) Evaluation in Elderly Patients with Advanced NSCLC
Date of disclosure of the study information 2009/06/29
Last modified on 2016/06/03

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Basic information
Public title Phase II Study of TS-1 with Patient-Reported Outcome(PRO) Evaluation in Elderly Patients with Advanced NSCLC
Acronym STEP Clinical Study
Scientific Title Phase II Study of TS-1 with Patient-Reported Outcome(PRO) Evaluation in Elderly Patients with Advanced NSCLC
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Yasuhiko Nishioka
Organization Institute of Health Biosciences,The University of Tokushima Graduate School
Division name Department of Respiratory Medicine & Rheumatology
Zip code
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
1st name
Middle name
Last name Hisatsugu Goto
Organization Institute of Health Biosciences,The University of Tokushima Graduate School
Division name Department of Respiratory Medicine & Rheumatology
Zip code
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

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)

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
2009 Year 06 Month 29 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
2009 Year 04 Month 27 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000002487

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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