A clinical study of gene expression models for predicting response to S-1 in patients with head and neck squamous cell carcinoma

A clinical study of gene expression models for predicting response to S-1 in patients with head and neck squamous cell carcinoma - Development of the prediction model for chemotherapeutic response to S-1 in head and neck cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007767

Enrollment

100

Registered

2012-04-16

Start date

2010-01-01

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

Patients who are suitable for S-1 chemotherapy as a first-line treatment in head and neck squamous cell carcinoma.

Interventions

Collect primary tumor and corresponding normal tissue specimens from patients enrolled in this study.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Primary squamous cell carcinoma of head and neck 2. New or recurrent case 3. Enable sampling of primary tumor 4. Have evaluable tumor region 5. No previous history of chemotherapy nor radiotherapy 6. Not treated with combined radiotherapy or other anticancer drugs 7. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 8. Adequate organ functions; white blood cell count or WBC, >3,500/mm3, <12,000/mm3; platelet count or Plt, >100,000/mm3; neutrophil count or Neu, >2000/mm3; hemoglobin or Hb >9.0g/dl; total serum bilirubin, 1.5 times of normal range in each institute; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT, 2.5 times of normal range in each institute; creatinine clearance or CCr (or e-GFR), >80ml/minute 9. Adult patients aged 20 years or older 10. Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ 2. Women during pregnancy or breast-feeding 3. Severe mental disease 4. Continuous systemic steroid therapy

Design outcomes

Primary

Measure	Time frame
Tumor response	—

Secondary

Measure	Time frame
Progression-free and overall survival	—

Countries

Japan

Contacts

Public ContactHitomi Yamagami

Koshin Chemical Inc. Division of Business Development

nomura-hitomi@koshin-chem.co.jp043-223-0067

Outcome results

None listed

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