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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023398
Receipt No. R000023120
Official scientific title of the study Multi-institutional Clinical Trial of Carbon-ion Radiotherapy for Peripherally located Inoperable Stage-I Non-small-cell Lung Cancer
Date of disclosure of the study information 2016/11/01
Last modified on 2017/01/27

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Basic information
Official scientific title of the study Multi-institutional Clinical Trial of Carbon-ion Radiotherapy for Peripherally located Inoperable Stage-I Non-small-cell Lung Cancer
Title of the study (Brief title) Multi-institutional Clinical Trial of C-ion RT for Peripherally Stage-I NSCLC
Region
Japan

Condition
Condition Peripherally located inoperable 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 peripherally located inoperable stage I non-small-cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 3-year overall survival rate
Key secondary outcomes Toxicities
Median survival time
2-year overall survival rate
2- and 3-year cause-specific survival rate
2- and 3-year progression-free survival rate
2- and 3-year local-progression-free rate
2- and 3-year local-progression-free survival rate
Pattern of recurrences

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Carbon-ion radiotherapy
60.0GyRBE/4fractions (15.0GyRBE/fraction)
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1)Pathologically confirmed or clinically diagnosed NSCLC
2)Clinically T1-T2aN0M0 diagnosed by imaging examinations including FDG-PET, and peripherally located
3)Considered to be unfit to lobar resection by cancer board including thoracic surgeon, pulmonary medical oncologist and radiation oncologist
4)Exist of lesion for evaluation
5)Initial treatment for the lesion
6)PS(ECOG) 0-2
7)SpO2 >= 90% or PaO2 >= 60 torr(mmHg)
8)FEV1.0 >= 700ml
9)>= 20 years-old / =< 90 years-old
10)Written informed consent
Key exclusion criteria 1)Severe comorbidities including infection and mental disorders
2) Interstitial pneumonitis on CT images
3)Coexisting malignancies within 2 years excepting Carcinoma in situ, stage-I laryngeal cancer, stage-I prostate cancer and stage-I breast cancer
4)History of thoracic irradiation
5)Pregnancy
6)Enrolled in other clinical trials
7)Other reasons judged by physician
Target sample size 150

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, Makoto Shinoto
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 1501lung@saga-himat.jp

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

Funding Source
Organization National Institute of Radiological Sciences
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 YES
Study ID_1 J-CROS 1501 LUNG
Org. issuing International ID_1 Japan Carbon-ion Radiation Oncology Study Group
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(佐賀県)、放射線医学総合研究所病院(千葉県)、群馬大学重粒子医学研究センター(群馬県)、兵庫県立粒子線医療センター(兵庫県)、神奈川県立がんセンター(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 04 Month 05 Day
Anticipated trial start date
2016 Year 11 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 29 Day
Last modified on
2017 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023120

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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