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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016575
Receipt No. R000018984
Official scientific title of the study Real-time tumor-tracking proton beam therapy for lung cancer
Date of disclosure of the study information 2015/02/26
Last modified on 2016/08/21

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Basic information
Official scientific title of the study Real-time tumor-tracking proton beam therapy for lung cancer
Title of the study (Brief title) Real-time tumor-tracking proton beam therapy for lung cancer
Region
Japan

Condition
Condition Primary lung cancer
Classification by specialty
Pneumology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety and efficacy of real-time tumor-tracking proton beam therapy for non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Incidence of radiation pneumonitis at six months after real-time tumor-tracking proton beam therapy
Key secondary outcomes 3-year overall survival, local control, progression free survival, recurrence pattern, incidence of adverse effect, incidence of dropout and migration of Au markers during treatment period

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 Real-time tumor-tracking proton beam therapy
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 proven non-small cell lung cancer
2) T1-3N0M0(UICC 7th edition)
3) Inoperative or operation refused
4) Visible target on CT
5) ECOG-PS 0-2
6) Age 20-yrs old or over at the time of consent form is obtained
7) Explained well and consent to this study
Key exclusion criteria 1) With active infections in the irradiated sites
2) With active other cancers
3) With severe uncontrolled diabetes
4) With severe renal failure which needed dialysis
5) With severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia
6) Previous thoracic irradiation
7) Previous chemotherapy within 12 months before enrollment
8) FEV 1.0 under 700 ml
9) With implantable cardioverter defibrillator or permanent pacemaker
10) Pregnancy
11) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis
12) Cannot be held rest for about 30 minutes
13) Weight over 135 kg
14) Cannot be implanted Au marker in the lung
15) Allergic to radiation
16) Unsuitable for enrollment judged by principal investigator
Target sample size 31

Research contact person
Name of lead principal investigator Hiroki Shirato
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Medicine
Address North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL +81-11-706-5977
Email shirato@med.hokudai.ac.jp

Public contact
Name of contact person Tetsuya Inoue
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Medicine
Address North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL +81-11-706-5977
Homepage URL
Email t-inoue@med.hokudai.ac.jp

Sponsor
Institute Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 26 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 01 Month 14 Day
Anticipated trial start date
2015 Year 02 Month 25 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
2015 Year 02 Month 18 Day
Last modified on
2016 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018984

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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