UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004295 |
|---|---|
| Receipt number | 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 11:28:44 |
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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
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
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005116
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
