UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced lung squamous cell carcinoma
Title of the study (Brief title)	Phase II study of S-1continuation maintenance therapy following CBDCA/S-1 in lung squamous cell carcinoma NSCLC :S-COT
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to examine the efficacy and safety of combination chemotherapy with S-1 and carboplatin in advanced lung squamous cell carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Overall survival, 1-year survival Rate, Response Rate, Safety

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Patients receive 4 courses of CBDCA/S-1. Chemotherapy with S-1 is continued for patients who do not have PD
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or pathologically proven lung squamous cell carcinoma 2) Locally advanced or metastatic, recurrent non-small cell lung cancer 3) Age more than 20 years 4) Performance status (ECOG) of 0-1 5) Life expectancy of more than 3 months 6) Patients with ability of oral intake 7) Patients who has at least one or more measurable lesion by RECIST 8) Patients who have adequate organ function 9) Written informed consent
Key exclusion criteria	1) Patients who received previous treatment with the 5-FU 2) Patients who is contraindicated to administration of CBDCA and S-1 3) Patients with a history of the drug hypersensitivity 4) Patients with symptomatic metastases to brain 5) Uncontrolled massive pleural effusion, ascitic fluid and pericardial fluid retention case 6) Patients with watery diarrhea 7) Patients with serious complications 8) Patients with active concomitant malignancy 9) Patients with HBs antigen-positive or with HCV antibody-positive 10) Patients who uses flucytosine 11) Women with the pregnant possibility, a pregnancy or lactation and men with willing to get pregnant 12) Patients who were complicated with mental disease or neurologic manifestation, and it is judged that the participation in study is difficult 13) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	Kingo Chida
Organization	Hamamatsu University School of Medicine
Division name	The Second Division, Department of Internal Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu City 431-3192, Shizuoka Prefecture, Japan
TEL
Email

Public contact
Name of contact person	Yasuhiro Ito
Organization	Hamamatsu University School of Medicine
Division name	The Second Division, Department of Internal Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu City 431-3192, Shizuoka Prefecture, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	浜松医科大学付属病院（静岡県） 浜松医科大学呼吸器内科グループ

Other administrative information
Date of disclosure of the study information	2012 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 14 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2015 Year 12 Month 01 Day
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	2011 Year 12 Month 28 Day
Last modified on	2016 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008237