Clinical phase I study of S-1-concurrent carbon ion radiotherapy for squamous cell carcinoma of the nasal cavity and paranasal sinuses

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012135

Enrollment

Registered

2013-10-28

Start date

2013-09-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous cell carcinoma of the nasal cavity and paranasal sinuses

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. No previous radiotherapy to the tumor site 2. No active concomitant malignancy

Design outcomes

Primary

Measure	Time frame
To determine MTD and estimate RD of S-1	—

Secondary

Measure	Time frame
Safety and anti-tumor effect	—

Countries

Japan

Contacts

Public ContactMasanori Naniwa

Hyogo Ion Beam Medical Center Division of General Affairs

m.naniwa@hibmc.shingu.hyogo.jp0791-58-1315

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026