UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of efficacy and safety of continouation maintenance therapy with gemcitabine after cisplatin-gemcitabine induction chemotherapy in advanced squamous cell lung cancer (KTORG1302)
Title of the study (Brief title)	Assessment of efficacy and safety of CDDP+GEM followed by GEM in advanced squamous cell lung cancer
Region	Japan

Condition
Condition	squamous cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of continuation maintenance therapy with gemcitabine after cisplatin-gemcitabine induction chemotherapy in advanced squamous cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Progression Free Survival
Key secondary outcomes	Overall survival Safety response rate

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	Induction chemotherapy(4 courses) Gemcitabine(GEM):1000mg/m2, day1,8 Cisplatin(CDDP):80mg/m2, day1 contunuation meintenance chemotherapy(until PD) Gemcitabine(GEM):1000mg/m2 day1,8
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	1) Patients with histologically proven squamous cell lung cancer 2) No prior chemotherapy for squamous cell lung cancer or one year after operation or adjuvant chemotherapy 3) Age 20 to 75 years 4) Performance status(ECOG) 0 or 1 5) Measurable disease according to RECIST ver 1.1 6) Sufficient organ functions 7) Life expectancy of more than 3 months 8) Written informed consent
Key exclusion criteria	1) Patients with histologically proven non-squamous cell lung cancer 2) Recognized ILD or pulmonary fibrosis on X-rays 3) Pleural effusion, peritoneal fluid and pericardial fluid that need treatment 4) Superior vena cava syndrome 5) Symptomatic brain metastasis 6) Active concomitant malignancy 7) Prior therapy with gemcitabine 8) Diabetes and hypertension that cannot be controlled 9) Liver cirrhosis 10) Symptomatic or asymptomatic but treated heart disease 11) Severe infectious disease 12) Pregnant women, possibly pregnant women, wishing to become pregnant 13) Serious drug hypersensitivity or a history of drug allergy 14) Refusal of supportive care such as blood transfusion 15) Bleeding tendency 16) Other conditions not suitable for this study
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroshige Yoshioka
Organization	Kurashiki Central Hospital (Ohara HealthCare Foundation)
Division name	Department of Respiratory Medicine
Address	1-1-1 Miwa, Kurashiki City, Okayama, 710-8602 JAPAN
TEL	086-422-0210
Email	hirotin@kchnet.or.jp

Public contact
Name of contact person	Satoshi Ikeda
Organization	Kurashiki Central Hospital (Ohara HealthCare Foundation)
Division name	Department of Respiratory Medicine
Address	1-1-1 Miwa, Kurashiki City, Okayama, 710-8602 JAPAN
TEL	086-422-0210
Homepage URL
Email	si13546@kchnet.or.jp

Sponsor
Institute	Kyoto Thoracic Oncology Research Group (KTORG)
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)

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	兵庫県立尼崎病院（兵庫県）、大津赤十字病院（滋賀県）、京都桂病院（京都府）、北野病院（大阪府）、神戸市立医療センター中央市民病院（兵庫県）、神戸市立医療センター西市民病院（兵庫県）、大阪府済生会中津病院（大阪府）、福井赤十字病院（福井県）、姫路医療センター（兵庫県）、神鋼病院（兵庫県）、京都医療センター（京都府）、彦根市立病院（滋賀県）、市立長浜病院（滋賀県）、倉敷中央病院（岡山県）、京都大学附属病院（京都府）、民医連京都中央病院（京都府）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 04 Month 11 Day
Anticipated trial start date	2013 Year 05 Month 15 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	2013 Year 05 Month 14 Day
Last modified on	2016 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012527