UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004568
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email rinsho@fuji-pvc.jp

Sponsor
Institute Protocol team for S-1 with leucovorin therapy
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005456

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.