UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase3 study of docetaxel/TS-1 versus docetaxel in patients with previously treated non-small cell lung cancer
Title of the study (Brief title)	KRSG-1301
Region	Japan

Condition
Condition	Non-small cell lung cancer patients with postoperative recurrence or stage3-4 with chemotherapy treatment history
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	As a treatment for secondary treatment and later for non-small cell lung cancer patients treated with DTX monotherapy and TS-1 combination therapy and DTX, I compare the progression free survival (PFS) .
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	progression free survival (PFS)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	docetaxel 35mg/m2 biweekly + TS-1 80-120mg/day from day1 to day 7 in two weeks
Interventions/Control_2	docetaxel 60mg/2 triweekly
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)Patients with histological diagnosis has been diagnosed with non-small cell lung cancer or in cytology 2)Non-small cell lung cancer of unresectable, cases of Stage 3B or 4 Stage or radical irradiation is not possible 3)Patients with measurable disease 4)Chemotherapy treatment history are cases of one regimen over the previous 5)It has passed more than 4 weeks if the four days or more chemotherapy if due to molecular targeted agents before, more than two weeks if UFT, an anti-tumor agent of the other is being used 6)Performance status(ECOG) is 0-2 7)Age of patients over 20 years old 8)Cases survival of 3 months or more is expected 9)Cases (bone marrow, lung, liver, and kidney) function has been held sufficient major organs
Key exclusion criteria	1)Patients with severe infection is suspected or there is fever cases are complicated by severe infection 2)Cases where there is intention or possibility pregnant women, pregnancy and breast-feeding 3)Patients having double cancer of activity of simultaneity, and multiple cancer or metachronous 4)Patients with severe drug allergy 5)Cases of bleeding (hemorrhagic enteritis, ischemic colitis, necrotizing enterocolitis) and gastrointestinal ulceration 6)Cases is determined pulmonary fibrosis or interstitial pneumonia is a problem in clinical CT images from 7)Cases are complicated by lung disease emphysema of advanced, chronic bronchitis severe, such as bronchial asthma 8)Cases with pleural effusion in need of treatment of drainage, etc., and storage of pericardial effusion 9)Brain metastasis of symptomatic 10)Patients with a myocardial infarction within 3 months after onset (diabetes that is difficult to control, liver damage (cirrhosis), renal failure, angina, and arrhythmia) and serious complication 119Patients with a history of administration TS-1 or DTX before treatment 12)Case it is determined to be inappropriate other attending physician to safely performed this study
Target sample size	260

Research contact person
Name of lead principal investigator	kunihiko kobayashi
Organization	Saitama medical university international medical center
Division name	Respiratory medicine
Address	1397-1,Yamane Hidakashi Saitamaken
TEL	042-984-4667
Email	kobakuni@saitama-med.ac.jp

Public contact
Name of contact person	kunihiko kobayashi
Organization	Saitama medical university international medical center
Division name	Respiratory medicine
Address	1397-1,Yamane Hidakashi Saitamaken
TEL	042-984-4111
Homepage URL
Email	kobakuni@saitama-med.ac.jp

Sponsor
Institute	Kanto respiratory disease study group
Institute
Department

Funding Source
Organization	Kanto respiratory disease study group
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	2013 Year 08 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 03 Day
Anticipated trial start date	2013 Year 08 Month 08 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 08 Month 06 Day
Last modified on	2016 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013341