UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000817 |
|---|---|
| Receipt number | R000000932 |
| Scientific Title | Phase II study of TS-1 for patients with advanced non-small cell lung cancer treated with prior chemotherapy. |
| Date of disclosure of the study information | 2007/09/05 |
| Last modified on | 2016/02/26 17:10:03 |
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Basic information
Public title
Phase II study of TS-1 for patients with advanced non-small cell lung cancer treated with prior chemotherapy.
Acronym
Phase II study of TS-1 for patients with advanced non-small cell lung cancer treated with prior chemotherapy.
Scientific Title
Phase II study of TS-1 for patients with advanced non-small cell lung cancer treated with prior chemotherapy.
Scientific Title:Acronym
Phase II study of TS-1 for patients with advanced non-small cell lung cancer treated with prior chemotherapy.
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy and safety of TS-1 for patients with advanced non-small cell lung cancer treated with prior chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate, time to progression, toxicity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
June, 2007-December, 2008
Regimen: TS-1
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
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Non-small cell lung cancer
2) Stage IIIB or IV
3) Performance status(ECOG) 0-1
4) Prior chemotherapy
5) Adequate haematopoietic function
6) Adequate liver and renal function
7) Each patient signed a written informed consent
Key exclusion criteria
1) Massive pleural effusion
2) Massivepericardial effusion
3) Interstitial pneumonitis
4) Uncontrolled brain metastasis
5) Active infection
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
095-849-7273
naho-k@mue.biglobe.ne.jp
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
3-15 Mori-machi, Nagasaki, Japan
TEL
095-847-1511
Homepage URL
takasai@tochigi-cc.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
None
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 | 09 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | 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
| 2007 | Year | 09 | Month | 04 | Day |
Last modified on
| 2016 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000932
