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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005585
Receipt No. R000006512
Official scientific title of the study Dose-escalation study of proton beam therapy with chemotherapy for locally advanced non-small lung cancer
Date of disclosure of the study information 2011/05/12
Last modified on 2016/04/23

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Basic information
Official scientific title of the study Dose-escalation study of proton beam therapy with chemotherapy for locally advanced non-small lung cancer
Title of the study (Brief title) Proton beam therapy dose escalation for NSCLC
Region
Japan

Condition
Condition Unresectable Non-small Lung Cancer
Classification by specialty
Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To define the recommended dose of proton beam therapy concurrent with chemotherapy for unresectable non-small lung cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes To determine maximum torrelated dose and recommended dose
Key secondary outcomes Adverse event
Tumor response
survival rate

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
Medicine Device,equipment
Interventions/Control_1 Proton beam therapy 66-74 GyE
(Cisplatin 60mg/m2 + TS-1 40mg d1-d4)
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
27 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Histologically proven Non-small lung cancer, Stage IIIA-IIIB
ECOG PS 0-1
Tumor size was measured by 4 wks before registration
Good organ function
Key exclusion criteria Drug allergy
Active infection
Lymph node metastasis at contra-lateral hiller, supraclavicular region. P
Severe complication
Apparent interstitial pneumonitis
Target sample size 12

Research contact person
Name of lead principal investigator Hiroshi Fuji
Organization Shizuoka Cancer Center
Division name Division of Proton therapy
Address 1007 Shimonagakubo, Nagaizumi-cho, Shizuoka-pref.
TEL 055-989-5222
Email

Public contact
Name of contact person Hiroshi Fuji
Organization Shizuoka Cancer Center
Division name Division of Proton therapy
Address 1007 Shimonagakubo, Nagaizumi-cho, Shizuoka-pref.
TEL 055-989-5222
Homepage URL
Email h.fuji@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

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 静岡県立静岡がんセンター(静岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 12 Day

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 04 Month 19 Day
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
2013 Year 04 Month 01 Day
Date trial data considered complete
2013 Year 04 Month 01 Day
Date analysis concluded
2015 Year 10 Month 01 Day

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

Management information
Registered date
2011 Year 05 Month 11 Day
Last modified on
2016 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006512

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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