Clinical trial of postoperative chemotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma

Clinical trial of postoperative chemotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma - Clinical trial of postoperative chemotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009628

Enrollment

Registered

2012-12-25

Start date

2013-01-01

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

Oral squamous cell carcinoma

Interventions

Radiotherapy RT: Fractionated radiation therapy: 66Gy/33Fr Alternate-day oral therapy with TS-1 + Radiotherapy TS-1: 80mg/body alternate-day treatment (4days/week) RT: Fractionated radiation ther

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Primary lesion located at oral cavity, and histologically proven squamous cell carcinoma 2) Pathological stage III, IVA or IVB (UICC 7th editio) 3) high risk of locoregional recurrence defined as fulfilling one or more of following factors. i) Microscopically closed resection margin (<5mm) ii) Extracapsular nodal extension iii) Multiple cervical lymph node metastases (&#8805;pN2) 4) Within 56 days from surgery 5) No distant metastasis 6) Aged 20 to 80 years old 7) ECOG performance status (PS) of 0 or 1 8) No prior radiation therapy, chemotherapy, nor hormonal therapy 9) Adequate organ functions 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers 2) Administration contraindication of TS-1 3) Serious postoperative complications 4) Watery diarrhea 5) One or more of following comorbid disorder Poor controlled diabetes, poor controlled hypertension, hepatic cirrhosis, hepatic insufficiency, renal failure, interstitial pneumonia, fibroid lung, severe pulmonary emphysema, active infectious disease, heart failure for not more than 6 months, cardiac infarction, severe aberration of electrocardiogram 6) Pleural effusion, pericardiac effusion, or ascites to be drained. 7) Continuous flucytosine, phenytoin, and warfarin potassium treatment 8) Severe drug allergy 9) Psychiatric disease 10) Women during pregnancy, possible pregnancy, or breast-feeding 11) Men with making pregnant 12) Cases judged to be inappropriate by attending physician

Design outcomes

Primary

Measure	Time frame
Disease-free survival	—

Secondary

Measure	Time frame
1) Overall survival 2) Relapse-free survival 3) Local relapse-free survival 4) Proportion of treatment completion	—

Countries

Japan

Contacts

Public ContactSouichi Yanamoto

Nagasaki University Graduate School of Biomedical Sciences Department of Clinical Oral Oncology, Unit of Translational Medicine

syana@nagasaki-u.ac.jp095-819-7698

Outcome results

None listed

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