UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004568 |
|---|---|
| Receipt number | R000005456 |
| Scientific Title | Phase II study of oral S-1 plus oral leucovorin in patients with previously treated non-small-cell lung cancer |
| Date of disclosure of the study information | 2010/11/16 |
| Last modified on | 2017/08/23 19:58:16 |
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Basic information
Public title
Phase II study of oral S-1 plus oral leucovorin in patients with previously treated non-small-cell lung cancer
Acronym
Oral S-1 with leucovorin in non-small cell lung cancer
Scientific Title
Phase II study of oral S-1 plus oral leucovorin in patients with previously treated non-small-cell lung cancer
Scientific Title:Acronym
Oral S-1 with leucovorin in non-small cell lung cancer
Region
| Japan |
Condition
Condition
Pre-treated non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of S-1 with leucovorin in patients with pre-treated non-small cell lung cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
Safety, overall survival, progression free survival, and 1-year survival
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
Oral S-1 with leucovorin
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with measurable disease and good performance status
Key exclusion criteria
patients with symptomatic brain metastasis
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tateaki Naito |
Organization
Shizuoka Cancer Center
Division name
Division of thoracic oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi, Sunto, Shizuoka, JAPAN
TEL
055-989-5222
t.naito@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Megumi Isii |
Organization
Pharma Valley Center
Division name
Clinical trial center
Zip code
Address
1007 Shimonagakubo, Nagaizumi, Sunto, Shizuoka, JAPAN
TEL
055-980-6322
Homepage URL
rinsho@fuji-pvc.jp
Sponsor or person
Institute
Protocol team for S-1 with leucovorin therapy
Institute
Department
Personal name
Funding Source
Organization
Pharma Valley Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
大阪総合医療センター（大阪府）、九州がんセンター（福岡県）、近畿大学（大阪府）、国立がん研究センター東病院（東京都）、静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 16 | 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
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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 | 11 | Month | 16 | Day |
Last modified on
| 2017 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005456
