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 |
Clinical phase I study of S-1-concurrent carbon ion radiotherapy for squamous cell carcinoma of the nasal cavity and paranasal sinuses
Phase I study of S-1-concurrent CIRT for nasal cavity and paranasal sinus SCC
Clinical phase I study of S-1-concurrent carbon ion radiotherapy for squamous cell carcinoma of the nasal cavity and paranasal sinuses
Phase I study of S-1-concurrent CIRT for nasal cavity and paranasal sinus SCC
Japan |
Squamous cell carcinoma of the nasal cavity and paranasal sinuses
Hematology and clinical oncology | Oto-rhino-laryngology | Radiology |
Malignancy
NO
To determine MTD and estimate RD of S-1 administered concurrently with carbon ion radiotherapy
Safety
Confirmatory
Pragmatic
Phase I
To determine MTD and estimate RD of S-1
Safety and anti-tumor effect
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
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
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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
1. No previous radiotherapy to the tumor site
2. No active concomitant malignancy
6
1st name | |
Middle name | |
Last name | Yusuke Demizu |
Hyogo Ion Beam Medical Center
Department of Radiology
1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
0791-58-1315
y_demizu@nifty.com
1st name | |
Middle name | |
Last name | Masanori Naniwa |
Hyogo Ion Beam Medical Center
Division of General Affairs
1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
0791-58-1315
http://www.hibmc.shingu.hyogo.jp/
m.naniwa@hibmc.shingu.hyogo.jp
Hyogo Ion Beam Medical Center
Hyogo Ion Beam Medical Center
Self funding
NO
兵庫県立粒子線医療センター(兵庫県)
2013 | Year | 10 | Month | 28 | Day |
Unpublished
Completed
2013 | Year | 09 | Month | 01 | Day |
2013 | Year | 09 | Month | 26 | Day |
2013 | Year | 10 | Month | 28 | Day |
2016 | Year | 04 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014187