UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000007738