UMIN-CTR Clinical Trial

Basic information
Public title	Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
Acronym	A feasibikity study of IMRT for locally advanced NSCLC
Scientific Title	Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
Scientific Title:Acronym	A feasibikity study of IMRT for locally advanced NSCLC
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A feasibility of chemoradiotherapy using IMRT for locally advanced NSCLC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	The ratio of the patients who completed chemoradiotherapy using IMRT
Key secondary outcomes	safety, progression free survival, overall survival, first relapse site

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 Device,equipment
Interventions/Control_1	Chemotherapy and IMRT
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) Histologically or cytologically confirmed NSCLC 2) Inoperable 3) Stage III NSCLC patients who are suitable for definitive RT 4) No previous chemotherapy and thoracic radiotherapy 5) Who have measurable lesions 6) Age 20-74 years old 7) Performance status 0,1 8) Who are able to eat by oral intake 9) Who are without severe co-morbid conditions 10) Informed consent
Key exclusion criteria	1)Active double cancer 2)History of severe infections or complications 3)HBs antigen positive 4)History of thoracic radiotherapy 5)Radiographically (chest CT image) confirmed interstitial pneumonitis or pulmonary fibrosis 6)Severe emphysema, chronic bronchitis, asthma 7)History of drug-induced pneumonia or severe drug allergies 8)Uncontrolled diabetes despite continuing treatment of insulin 9)Unstable angina, cardiac infarction within 6 months before enrollment 10)A fever of over 38 degrees 11)Continuous systemic administration of steroid or immunosuppressant 12)Pregnant women 13)Patients with severe mental illness 14)Unsuitable patients judged by the attending physician
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideyuki Harada
Organization	Shizuoka Cancer Center
Division name	Radiation Oncology
Zip code
Address	1007 shimonagakubo, nagaizumi, Shizuoka.
TEL	81559895222
Email	h.harada@scchr.jp

Public contact
Name of contact person	1st name Middle name Last name Hideyuki Harada
Organization	Shizuoka Cancer Center
Division name	Radiation Oncology
Zip code
Address	1007 shimonagakubo, nagaizumi, Shizuoka
TEL	81559895222
Homepage URL
Email	h.harada@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	静岡がんセンター（静岡県）近畿大学（大阪府）大阪府済生会中津病院（大阪府）先端医療センター（兵庫県）広島大学（広島県）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 02 Day
Last modified on	2016 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020049

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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