UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.
Title of the study (Brief title)	A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.
Region	Japan

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

Objectives
Narrative objectives1	To assess the efficacy and safety of TS-1+Cisplatin or Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	2 year survival rate
Key secondary outcomes	Over all survival, Progression free survival, Compliance rate of protocol regimen, Adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TS-1+Cisplatin+ radiation
Interventions/Control_2	VNR+ Cisplatin+ radiation
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	-Histologically or cytologically confirmed NSCLC -No prior chemotherapy, radiotherapy or surgery (Open biopsy is allowed). -Unresectable lung cancer Stage 3A or 3B. -V20 <= 35% -Oral intake is possible -Adult patients (>=20,<75 years of age) -ECOG performance status 0 or 1 -Adequate organ function. -Laboratory values must be as follows; WBC count >= 4,000/mm3, Neutrophil count >= 2,000/mm3 hemoglobin >= 9.5g/dL, Platelet count >= 100,000/mm3 AST and ALT <= 100IU/LBilirubine level <= 1.5 mg/dL, Serum creatinine <= 1.5 mg/dL Creatinine clearance >= 60 mL/min, PaO2 >= 70 torr -Patients must sign an informed consent.
Key exclusion criteria	-T3N1 -SVC syndrome. -Clinically significant pleural or pericardial effusion,Contralateral Hilar lymph node metastasis, -Patients with concurrent serious infections or complications -Continuous watery diarrhea -Paralysis of the intestine, or ileus -Significant interstitial pneumonitis ,pulmonary fibrosis or severe emphysema in Chest Xp -The presence of other concomitant cancers -Concomitant therapy with another new anticancer drug, phenytoin, warfarin or flucytocine -Inadequately controlled diabetes mellitus -HBs Ag is positive -A history of serious drug allergy -Mental disease or psychotic manifestation -Pregnancy,breast feeding or wish of future bearing -Other conditions not suitable for this study
Target sample size	110

Research contact person
Name of lead principal investigator	Tomonari Sasaki
Organization	Graduate School of Medical Sciences Kyushu University
Division name	Department of Radiology
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL	092-642-5378
Email	tomonari@radiol.med.kyushu-u.ac.jp

Public contact
Name of contact person	Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Address	Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	TAIHO PHARMACEUTICAL CO.,LTD
Organization
Division
Category of Funding Organization	Profit organization
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	2009 Year 09 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 05 Month 23 Day
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date	2014 Year 09 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	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/30206369
Results
Other related information

Management information
Registered date	2009 Year 09 Month 01 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002965