UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical phase I study of S-1-concurrent carbon ion radiotherapy for squamous cell carcinoma of the nasal cavity and paranasal sinuses
Title of the study (Brief title)	Phase I study of S-1-concurrent CIRT for nasal cavity and paranasal sinus SCC
Region	Japan

Condition
Condition	Squamous cell carcinoma of the nasal cavity and paranasal sinuses
Classification by specialty	Hematology and clinical oncology Oto-rhino-laryngology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine MTD and estimate RD of S-1 administered concurrently with carbon ion radiotherapy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	To determine MTD and estimate RD of S-1
Key secondary outcomes	Safety and anti-tumor effect

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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Carbon ion radiotherapy 70.4 GyE/32 Fx/6.4 wk S-1 Level 1: 40 mg/m2/day/14-day on, 7-day off, 14-day on Level 2: 60 mg/m2/day/14-day on, 7-day off, 14-day on Level 3: 80 mg/m2/day/14-day on, 7-day off, 14-day on
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Histologically confirmed squamous cell carcinoma of the nasal cavity and paranasal sinuses 2. ECOG Performance Status (PS): 0 or 1 3. Adequate organ function 4. Written informed consent
Key exclusion criteria	1. No previous radiotherapy to the tumor site 2. No active concomitant malignancy
Target sample size	6

Research contact person
Name of lead principal investigator	Yusuke Demizu
Organization	Hyogo Ion Beam Medical Center
Division name	Department of Radiology
Address	1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL	0791-58-1315
Email	y_demizu@nifty.com

Public contact
Name of contact person	Masanori Naniwa
Organization	Hyogo Ion Beam Medical Center
Division name	Division of General Affairs
Address	1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL	0791-58-1315
Homepage URL	http://www.hibmc.shingu.hyogo.jp/
Email	m.naniwa@hibmc.shingu.hyogo.jp

Sponsor
Institute	Hyogo Ion Beam Medical 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	Hyogo Ion Beam Medical Center
Organization
Division
Category of Funding Organization	Self funding
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	兵庫県立粒子線医療センター（兵庫県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 26 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	2013 Year 10 Month 28 Day
Last modified on	2016 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014187