UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective phase II study of stereotactic body radiation therapy using helical tomotherapy for stage IA non-small cell lung cancer.
Title of the study (Brief title)	SBRT with helical tomotherapy for lung cancer
Region	Japan

Condition
Condition	stage IA non-small cell lung cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess clinical feasibility of stereotactic body radiation therapy with helical tomotherapy for stage IA lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	3-year overall survival rate
Key secondary outcomes	overall survival time, relapse-free survival time, local pregression-free survival time, 3-year local progression free rate, type of recurrence, acute adverse event, late adverse event, ratio of severe adverse event

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	Device,equipment
Interventions/Control_1	patient number 50, accrual 4 years, follow-up 3years stereotactic body radiation therapy 60Gy/6fraction/8-12 days
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	Not applicable
Gender	Male and Female
Key inclusion criteria	histologically confirmed stage IA no mediastinal lymph node metastasis no previously radiotherapy history Performance status 0-2 medically unresectable or refuse of surgery written, informed consent
Key exclusion criteria	interstitial pneumonitis, lung fibrosis active infection active multiple cancer (last 3 years) pregnancy or breast feeding psychological disorder systemic steroid medication
Target sample size	50

Research contact person
Name of lead principal investigator	Takeshi Kodaira
Organization	Aichi Cancer Center Hospital
Division name	Department of Therapeutic Radiation Oncology
Address	1-1 Kanoko-den, Chikusa-ku 464-8681, Nagoya, Aichi
TEL	052-762-6111
Email	109103@aichi-cc.jp

Public contact
Name of contact person	Natsuo Tomita
Organization	Aichi Cancer Center Hospital
Division name	Department of Therapeutic Radiation Oncology
Address	1-1 Kanoko-den, Chikusa-ku 464-8681, Nagoya, Aichi
TEL	052-762-6111
Homepage URL
Email	ntomita@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization	Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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 02 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 02 Month 20 Day
Anticipated trial start date	2009 Year 02 Month 20 Day
Last follow-up date	2016 Year 02 Month 01 Day
Date of closure to data entry	2016 Year 02 Month 01 Day
Date trial data considered complete	2016 Year 02 Month 01 Day
Date analysis concluded	2016 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 02 Month 20 Day
Last modified on	2018 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002057