UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseII trial of Gemcitabine(G)and Platinam-doublet plus continuous maintenance Gemcitabine in untreated stage three/four squamous non-small cell lung cancer(NSCLC)
Title of the study (Brief title)	PhaseII trial of Gemcitabine(G)and Platinam-doublet plus continuous maintenance Gemcitabine in untreated stage three/four squamous non-small cell lung cancer(NSCLC)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the PFS and torelability of gemcitabin/platinum-doublet continuous maintenance gemcitabine in Japanese patients with untreated stage threeB/four non-small cell lung cancer for squamous cell carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression Free Survival
Key secondary outcomes

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	Four cycle of gemcitabine and platinum-doublet followed by maintenance gemcitabine in 21-days cycle until progression disease
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically confirmed squamous non-small cell lung cancer 2) Patients who have measurable lesion 3) Stage III/VI without any indications for radiotherapy, or recurrent disease after surgery 4) Patients aged from 20 older 5)ECOG PS 0-1 6) Adequate organ function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as WBC >= 4,000/mm3 Plt >= 100,000/mm3 Hb >= 9 g/dL AST/ALT <=100IU/L T.Bil <= 1.5 g/dL Ccr >=60mL/min, sCr: x 1.2 of upper limit of normal or less. SpO2 >= 60torr as room air 7) Patients are excepted to live over 3 months after administration day 8)Written informed consent from the patients
Key exclusion criteria	(1) Patient having clear infection (2) Patient having hepatitis B with the activity (3) Serious complications (stroma-related pneumonia, bleeding tendency, control are poor a heart trouble, pulmonary fibrosis) The patient whom high blood pressure or diabetes have) (4) Patient having an active overlap cancer (under nondisease period five years) (5) Metastasis to brain patient having a symptom (6) Hydrothorax to need treatment, abdominal dropsy retention patient (7) Pericardial fluid retention patient (8) Patient having an anamnesis of drug allergies (9) A pregnant woman, a nursing girl and woman with the possibility (intention) of the pregnancy (10) principal investigator cases that are deemed inappropriate
Target sample size	33

Research contact person
Name of lead principal investigator	Noboru Hattori
Organization	Graduate School of Biomedical Sciences Hiroshima University
Division name	Department of Molecular and Internal Medicine
Address	Kasumi 1-2-3, Minami-ku, Hiroshima
TEL	082-257-5555(5198)
Email	nhattori@hiroshima-u.ac.jp

Public contact
Name of contact person	Kazunori Fujitaka
Organization	Hiroshima University Hospital
Division name	Depatment of Respiratory Medicine
Address	Kasumi1-2-3, Minami-ku, Hiroshima
TEL	082-257-5196
Homepage URL
Email	fujikazu@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
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	広島市民病院（広島県）安佐市民病院（広島県）県立広島病院（広島県）広島総合病院（広島県）広島赤十字・原爆病院（広島県）三次中央病院（広島県）尾道総合病院（広島県）広島鉄道病院（広島県）

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 03 Month 15 Day
Anticipated trial start date	2013 Year 03 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 09 Month 18 Day
Last modified on	2018 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011491