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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012135
Receipt No. R000014187
Scientific Title Clinical phase I study of S-1-concurrent carbon ion radiotherapy for squamous cell carcinoma of the nasal cavity and paranasal sinuses
Date of disclosure of the study information 2013/10/28
Last modified on 2016/04/30

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Basic information
Public title Clinical phase I study of S-1-concurrent carbon ion radiotherapy for squamous cell carcinoma of the nasal cavity and paranasal sinuses
Acronym Phase I study of S-1-concurrent CIRT for nasal cavity and paranasal sinus SCC
Scientific Title Clinical phase I study of S-1-concurrent carbon ion radiotherapy for squamous cell carcinoma of the nasal cavity and paranasal sinuses
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Yusuke Demizu
Organization Hyogo Ion Beam Medical Center
Division name Department of Radiology
Zip code
Address 1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL 0791-58-1315
Email y_demizu@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Naniwa
Organization Hyogo Ion Beam Medical Center
Division name Division of General Affairs
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 09 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000014187

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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