UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	S-1 as second line for non-small cell lung cancer with preexisting interstitial pneumonia: phase II study.
Title of the study (Brief title)	S-1 as 2nd line for NSCLC with IP
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and safety of S-1 as second line for non-small cell lung cancer with preexisting interstitial pneumonia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression free survival (PFS)
Key secondary outcomes	overall survival 1 year survival rate response rate disease control rate safety incidence of acute exacerbation of preexisting interstitial pneumonia

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
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, day 1- 28, q6w. body surface area (BSA) >1.5m2 S-1 80 mg/day BSA 1.25 - 1.5m2 S-1 100 mg/day BSA > 1.5m2 S-1 120 mg/day
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) pathologically confirmed non small cell lung cancer 2) stage IIIB/IV or relapsed patients who received anti-cancer agents once. 3) patients with preexisting interstitial pneumonia 4) more than 20 years old 5) ECOG PS 0-2 6) life expectancy for more than 3 months 7) more than one measurable lesion 8) ability to take medications per oral 9) preserved main organs function 10) Informed consent with documents by participants.
Key exclusion criteria	1) deterioration of preexisting interstitial pneumonia within 3 months (acute/sub-acute cases) 2) history of acute exacerbation of preexisting interstitial pneumonia or drug induced lung injury. 3) taking corticosteroids more than 15 mg/day of prednisolon or equal 4) taking immunosuppressant 5) received irradiation to lung within 3 months 6) using home oxygen therapy (HOT) 7) history of treatment with fluorinated pyrimidine 8) contraindicated for S-1 9) symptomatic, unstable brain metastasis 10) with pleural or peritoneal effusions which need to be drainage 11) with watery diarrhea 12) with severe comorbidities considered to be obstacle for anti-cancer therapy. 13) with metachronous or synchronous multiple cancer 14) using flucytosine 15) being pregnant or have an intention to be or make pregnant, or breast feeding. 16) considered as inappropriate to be participant by the primary physician
Target sample size	28

Research contact person
Name of lead principal investigator	Takafumi Suda
Organization	Hamamatsu University School of Medicine
Division name	2nd division, Department of Internal Medicine
Address	1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, Japan. 431-3192
TEL	053-435-2111
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	Norimichi Akiyama
Organization	Hamamatsu University School of Medicine
Division name	2nd division, Department of Internal Medicine
Address	1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, Japan. 431-3192
TEL	053-436-1251
Homepage URL
Email	nakiyan@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 05 Month 11 Day

Progress
Recruitment status
Date of protocol fixation	2016 Year 05 Month 10 Day
Anticipated trial start date	2016 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 02 Day
Last modified on	2018 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025296