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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023076
Receipt No. R000026598
Official scientific title of the study A phase II clinical trial of carbon-ion radiotherapyfor patients with centrally located stage I non-small-cell lung cancer
Date of disclosure of the study information 2016/07/08
Last modified on 2016/07/08

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

Condition
Condition Centrally 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 centrally 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

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

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
Maneuver
Interventions/Control_1 Carbon-ion radiotherapy
68.4GyRBE/12fractions
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 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)Centrally located
7)No history of chemotherapy within 2 weeks
8)20 year-old or > 20 year-old
9) PS(ECOG)0-2
10)Estimated survival longer than 6 months
11)Writtened informed consent
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 20

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

Funding Source
Organization Nne
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
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=R000026598

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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