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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004295
Receipt No. R000005116
Scientific Title A Multi-center Phase II Clinical trial of 3rd and more line TS-1 treatment for Advanced NSCLC
Date of disclosure of the study information 2010/09/30
Last modified on 2012/04/17

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Basic information
Public title A Multi-center Phase II Clinical trial of 3rd and more line TS-1 treatment for Advanced NSCLC
Acronym A Multi-center Phase II Clinical trial of 3rd and more line TS-1 treatment for Advanced NSCLC
Scientific Title A Multi-center Phase II Clinical trial of 3rd and more line TS-1 treatment for Advanced NSCLC
Scientific Title:Acronym A Multi-center Phase II Clinical trial of 3rd and more line TS-1 treatment for Advanced NSCLC
Region
Japan

Condition
Condition NSCLC
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate effectiveness and the safety of 3rd and more line treatment of TS-1 in the patient with nonsmall cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes efficacy (Response Rate(CR+PR),Disease Control Rate(CR+PR+SD)
Key secondary outcomes Safety(Adverse events), PFS, OS

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 The dosage of TS-1 administers 80mg/m2/day.
And, it administers for 14 days, and it takes a rest for seven days afterwards.
The treatment period administers more than four courses or disease progression.
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 confirmed Non-Small Cell Lung Cancer
2)Advanced Stage (IV or IIIB)
3)previously treated by chemotherapy and failure
4)The case of prior Radiation therapy is accceptable. But It is necessary to pass for 4 weeks and more since last treatment and recovery adversed event
5)With measurable lesion
6)Oral intake is possible
7)20<=, years
8)Patients who have estimated life expectancy longer than 3 months
9)Performance Status(ECOG):0-2
10)Adequate organ functions
11)Written informed consent
Key exclusion criteria 1)Patients with serious infections or susupected infections with fever
2)complication of massive pericardial effusion, ascites or pleural sffusion
3)uncontrollable heart failure or Interstitial pneumonitis
4)Pregnant or lactating woman
5)Symptomatic brain metastasis
6)Hystory of active double cancer
7)poorly controled diabetes mellitus
8)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoji Ito
Organization Ehime University Graduate School of Medicine
Division name Integrated Medicine and Informatics Respiratory group
Zip code
Address Shitsukawa, Toon, Ehime
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Ehime University Graduate School of Medicine
Division name Integrated Medicine and Informatics Respiratory group
Zip code
Address Shitsukawa, Toon, Ehime
TEL
Homepage URL
Email

Sponsor
Institute Ehime University Graduate School of Medicine
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
2010 Year 09 Month 30 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
2010 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 29 Day
Last modified on
2012 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005116

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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