UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012135 |
|---|---|
| Receipt number | 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 00:10:04 |
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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
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/
m.naniwa@hibmc.shingu.hyogo.jp
Sponsor or person
Institute
Hyogo Ion Beam Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014187
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
