UMIN-CTR Clinical Trial

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

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
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

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	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

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	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