UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II clinical trial of carbon-ion radiotherapy for patients with peripherally located stage I non-small-cell lung cancer
Title of the study (Brief title)	phase II trial of carbon-ion radiotherapy for preipherally located stage I non-small-cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy and safety of Carbon-ion radiotherapy for peropherally located stage I non-small-cell 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 local control rate
Key secondary outcomes	3- and 5-year overall survival rate 3- and 5-year cause-specific survival rate 3- and 5-year progression-free survival rate Toxicities Pulmonary function (VC, FEV1.0) at 3 years

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Carbon-ion radiotherapy T1:54.0GyRBE/4fractions T2:64.0GyRBE/4fractions
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Pathologically confirmed NSCLC 2)Clinically T1-T2aN0M0 diagnosed by imaging examinations including FDG-PET 3)No history of thoracic irradiation 4)Medically inoperable or refuse surgery 5)Exist of lesion for evaluation 6)No history of chemotherapy within 2 weeks 7)20 year-old or > 20 year-old 8)Estimated survival longer than 6 months 9)Informed consent by document
Key exclusion criteria	1)Interstitial pneumonitis on CT images 2)< SpO2 94% 3)Severe infections in treatment area 4)Coexisting malignancies within 2 years excepting Carcinoma in Situ, stgae I laryngeal cancer, localized prostate cancer 5)Pregnancy 6)Unfit due to mental disorders 7)Continuouslly oral or intravenous administration of steroid 8)Other reasons judged by physician
Target sample size	65

Research contact person
Name of lead principal investigator	Yoshiyuki Shioyama
Organization	Ion Beam Therapy Center, SAGA-HIMAT Foundation
Division name	Department of Radiation Oncology
Address	3049 Harakoga-machi, Tosu, Japan
TEL	0942-81-1897
Email	shioyama-yoshiyuki@saga-himat.jp

Public contact
Name of contact person	Yoshiyuki Shioyama
Organization	Ion Beam Therapy Center, SAGA-HIMAT Foundation
Division name	Department of Radiation Oncology
Address	3049 Harakoga-machi, Tosu, Japan
TEL	0942-81-1897
Homepage URL
Email	shioyama-yoshiyuki@saga-himat.jp

Sponsor
Institute	Ion Beam Therapy Center, SAGA-HIMAT Foundation
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
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	九州国際重粒子線がん治療センター

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 08 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 03 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 01 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	2016 Year 07 Month 08 Day
Last modified on	2016 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026596