UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000793 |
|---|---|
| Receipt number | R000000951 |
| Scientific Title | Phase II study of TS-1 in elderly patients with unresectable non-small cell lung cancer |
| Date of disclosure of the study information | 2007/08/11 |
| Last modified on | 2012/06/17 02:31:43 |
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Basic information
Public title
Phase II study of TS-1 in elderly patients with unresectable non-small cell lung cancer
Acronym
Phase II study of TS-1 in elderly patients with unresectable non-small cell lung cancer
Scientific Title
Phase II study of TS-1 in elderly patients with unresectable non-small cell lung cancer
Scientific Title:Acronym
Phase II study of TS-1 in elderly patients with unresectable non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main objectives of this study is to define 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
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Time to progression, safety, survival time
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 40mg/m2/day twice a day (day1-28)
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically documented non-small cell lung cancer
2) Stage IIIB-IV
3) previously non-chemotherapy
4) Performance status: 0-1
5) Adequate hematopoietic function
6) Adequate hepatic and renal function
7) Patients signed written informed consent
Key exclusion criteria
1) Uncontroled pleural or pericardial effusion
2) Uncontroled brain metastasis
3) Interstitial pneumonitis, pulmonary fibrosis
4) Active infection
5) Uncontroled other disease
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kohno |
Organization
Nagasaki University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kasai |
Organization
Japanese Red Cross Nagasaki Atomic Bomb Hospital
Division name
Internal Medicine
Zip code
Address
TEL
Homepage URL
naho-k@mue.biglobe.ne.jp
Sponsor or person
Institute
Nagasaki Thoracic Oncology Group
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
| 2007 | Year | 08 | Month | 11 | 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
| 2006 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 07 | Day |
Last modified on
| 2012 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000951
