UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010564 |
|---|---|
| Receipt number | R000012357 |
| Scientific Title | A prospective cohort study to explore predictive factors to TS-1 plus platinum-based drugs in patients with squamous cell lung cancer YCRG10 |
| Date of disclosure of the study information | 2013/04/23 |
| Last modified on | 2018/10/29 08:50:38 |
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Basic information
Public title
A prospective cohort study to
explore predictive factors to TS-1 plus platinum-based drugs in patients with squamous cell lung cancer
YCRG10
Acronym
A prospective cohort study to
explore predictive factors to TS-1 plus platinum-based drugs in patients with squamous cell lung cancer
YCRG10
Scientific Title
A prospective cohort study to
explore predictive factors to TS-1 plus platinum-based drugs in patients with squamous cell lung cancer
YCRG10
Scientific Title:Acronym
A prospective cohort study to
explore predictive factors to TS-1 plus platinum-based drugs in patients with squamous cell lung cancer
YCRG10
Region
| Japan |
Condition
Condition
squamous cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to explore predictive factors whom treated with TS-1 plus platinum-based drugs(such as TS-1 plus Cisplatin or TS-1 plus Carboplatin) in chemotherapy-naïve patients with advanced squamous cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To evaluate correlation between tumor response and gene expression and protein levels in serum,whole blood and tissue
Key secondary outcomes
To evaluate correlation between PFS, OS, adverse events, relative dose intensity and gene expression and protein levels in serum,whole blood and tissue
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Advanced squamous cell lung cancer patients(no prior chemotherapy) who is planned to receive TS-1 plus platinum-based drugs
2)Patients age is older than 20 when registration
3)Patients whoes blood samples(
serum and whole blood) are available before treatment
4)Target lesion is evaluable
5)Written infomed consent from the patients
Key exclusion criteria
Patients whose participation in this study is judged to be inappropriate by the physicians
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kaneko |
Organization
Yokohama City University Medical Center
Division name
Respiratory Disease Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
takeshi@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaharu Shinkai |
Organization
Yokohama City University Medical Center
Division name
Respiratory Disease Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
shinkai@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
横浜市立大学附属市民総合医療センター（神奈川県）
横浜市立大学附属病院（神奈川県）
藤沢市民病院（神奈川県）
横浜船員保険病院（神奈川県）
横浜南共済病院（神奈川県）
国立病院横浜医療センター（神奈川県）
大和市立病院（神奈川県）
茅ヶ崎市立病院（神奈川県）
関東労災病院（神奈川県）
横浜栄共済病院（神奈川県）
神奈川県立がんセンター（神奈川県）
済生会横浜市南部病院（神奈川県）
横須賀市民病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is designed to be prospective cohort study.
The purpose of this study is to explore predictive factors whom treated with TS-1 plus platinum-based drugs (such as TS-1 plus Cisplatin or TS-1 plus Carboplatin) in chemotherapy-naïve patients with advanced squamous cell lung cancer.
To evaluate correlation between response and gene expression, we could estimate the population of sensitive patients to TS-1 plus platinum-based treatment.
50 patients is planned to be registered.(TS-1+CBDCA:25patients,TS-1+CDDP:25patients)
Continue until progression disease or unfeasible adverse events.
Management information
Registered date
| 2013 | Year | 04 | Month | 23 | Day |
Last modified on
| 2018 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012357
