Phase II trial of S-1 plus Cetuximab combination chemotherapy for advanced recurrent/metastatic carcinoma of the oral cavity

Phase II trial of S-1 plus Cetuximab combination chemotherapy for advanced recurrent/metastatic carcinoma of the oral cavity - S-1 plus Cetuximab combination chemotherapy for advanced recurrent/metastatic carcinoma of the oral cavity

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024371

Enrollment

Registered

2016-10-12

Start date

2016-10-07

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

Advanced recurrent/metastatic carcinoma of the oral cavity

Interventions

Cetuximab is administered intravenously once a week at a dose of 400mg/m2 for the first time and 250mg/m2 fir the second time or later. S-1 is administered orally twice a day at a dose of 40-60mg (80-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Inoperable recurrent/metastatic carcinoma of the oral cavity. 2) Age >=20 at the time giving the consent. 3) Written informed consent with given enough explanation and full comprehension at his/her discretion. 4) ECOG performance status of PS 0-2. 5) Measurable lesion. 6) Inappropriate for platinum-based therapy or the refusal. 7) Adequate organ functions within 14 days at the time of registration: 1. WBC >=3,000 /mm3 2. Neutrophil >=1,500 /mm3 3. Platemet >=100,000 /mm3 4. Hemoglobin >=9.0 g/dL 5. T-bilirubin <=one-and-a half times of ULN. 6. AST, ALT <=two-and-a half times of ULN. 7. Creatinin clearance <=40ml/min.

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity for the medicine of this study and the analogues. 2. receiving flucytocine. 3. possibly receiving flucytocine, HIV positive, or HBs antigen positive 4. Active infection requiring treatment. 5. Gastrointestinal disorder requiring treatment (paresis of intestine, ileus, etc). 6. Interstitial Pneumonia, pulmonary fibrosis 7. Uncontrolled diabetes mellitus. 8. Uncontrolled heart failure. 9. Severe liver failure. 10. Pregnant or lactating women or person in hope of the pregnancy of the partner. 11. Decision of ineligibility by a physician.

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Progression Free Survival Tumor response rate Safety and adverse event	—

Countries

Japan

Contacts

Public ContactMasaya Okura

Society of Osaka Oral Cancer Researches The First Department of Oral & Maxillofacial Surgery

okura@dent.osaka-u.ac.jp06-6879-2936

Outcome results

None listed

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