Comparison of the pharmacokinetics between the initial and reduced dose of S-1 in the patients with locally advanced head and neck cancer

Comparison of the pharmacokinetics between the initial and reduced dose of S-1 in the patients with locally advanced head and neck cancer - Comparison of the pharmacokinetics between the initial and reduced dose of S-1 in the patients with locally advanced head and neck cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025205

Enrollment

Registered

2017-12-07

Start date

2010-07-01

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

locally advanced head and neck cancer

Interventions

Induction CRT with S-1 plus cisplatin consisted of S-1 (60 mg/m2/day) administered repeated for two weeks orally or via PEG tube twice a day and cisplatin is infused on days 8 through 11 every 5 weeks

10 mm in size or not enhancing on contrast-enhanced CT) or PR (partial response) at the first evaluation after CRT.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibility required histologically or cytologically confirmed SCCHN with unresectable locally advanced disease. Patients had to meet all of the following inclusion criteria 1. primary lesion located in the nasopharynx, nasal cavity, paranasal sinuses, oropharynx, hypopharynx, larynx, oral cavity, or salivary gland fulfilling at least one of the following the conditions: a) primary lesion or cervical lymph node metastasis to the carotid space (bordering/encasing the artery), skull base, or cervical vertebra and/or its surrounding musculature ; b) T4 primary lesion located in the oropharynx 2. Age between 20 and 75 years 3. ECOG performance status of 0 or 1 4. sufficient organ function 5. normal electrocardiogram.

Exclusion criteria

Exclusion criteria: Exclusion criteria included fistulas, distant metastases, active bacterial or fungal infection; simultaneous or metachronous (within 5 years) second cancers except carcinoma in situ or intramucosal tumor (e.g., gastric or esophageal cancer curable by endoscopic mucosal resection); pregnancy or lactation; active gastrointestinal bleeding; pleural or pericardial effusion; massive ascites; history of severe heart disease, heart failure, myocardial infarction within 6 months, or angina pectoris attack within 6 months; cerebrovascular accident within 6 months; diabetes mellitus treated with insulin or poorly controlled; poorly controlled hypertension; chronic pancreatitis; positive HBs antigen; inability to refrain from smoking and drinking during treatment; and requirement for systemic steroids.

Design outcomes

Primary

Measure	Time frame
comparison of 5-FU AUC SS between the initial and reduced dose of S-1 in the patients	—

Secondary

Measure	Time frame
adverse event tumor reduction rate overall survival progression free survival time to treatment failure	—

Countries

Japan

Contacts

Public ContactTomoko Yamazaki

National Cancer Center Hospital East Division of Head and Neck Cancer Medical Oncology Division

tomoppy.and.you26@gmail.com04-7133-1111

Outcome results

None listed

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