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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006527
Receipt No. R000007738
Scientific Title Phase 2 study of S-1 for elderly patients with advanced non-small cell lung cancer
Date of disclosure of the study information 2011/10/12
Last modified on 2020/11/02

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Basic information
Public title Phase 2 study of S-1 for elderly patients with advanced non-small cell lung cancer
Acronym Phase 2 study of S-1 for elderly patients with advanced non-small cell lung cancer
Scientific Title Phase 2 study of S-1 for elderly patients with advanced non-small cell lung cancer
Scientific Title:Acronym Phase 2 study of S-1 for elderly patients with advanced non-small cell lung cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate efficacy and safety of S-1 for elderly patients with stage 3B/4 non-small Cell Lung Cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression-free survival, Overall survival, Safety, To explore EGFR status and K-ras status related to the effect.

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 S-1
50-120 mg/day, day1-14 every 3 weeks
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 proven non-small cell lung cancer.
2)Clinical stage IIIB, IV or recurrent disease after surgery.
3)With at least one or more measurable lesion by RECIST.
4)Aged 70 years or older.
5)ECOG performance status of 0 or 1.
6)No prior chemothearpy or radiotherapy for non-small Cell Lung Cancer.
7)Adequate organ function.
8)Oral intake is possible.
9)Life expectancy more than 3 months.
10)Written informed consent.
Key exclusion criteria 1)Active lung disease such as interstitial pneumonia or pulmonary fibrosis.
2)Uncontrollable pleural or pericardial effusion or ascites.
3)Simultaneous or metachronous double cancers.
4)Severe complications.
5)Symptomatic brain metastases.
6)The case suspected of infection with feaver.
7)Mental disease or psychotic manifestation.
8)A history of serious drug allergy.
9)A history of sever allergic reaction with S-1
10)A history of adjuvant chemotherapy including S-1.
11)Being treated with other pyrimidine fluoride antineoplastic agents.
12)Being treated with flucytosine.
13)Any patients judged by the investigator to be unfit to participate in the study.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Masuda
Organization Kitasato University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL 042-778-8111
Email masuda@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Takakura
Organization Kitasato University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL 042-778-8111
Homepage URL
Email takakura@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Department of Respiratory Medicine
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 12 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
2010 Year 08 Month 07 Day
Date of IRB
2010 Year 08 Month 01 Day
Anticipated trial start date
2010 Year 08 Month 07 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2019 Year 06 Month 30 Day
Date analysis concluded
2019 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 12 Day
Last modified on
2020 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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