Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy with S-1 after curative treatment in patients with squamous cell carcinoma of the head and neck

Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy with S-1 after curative treatment in patients with squamous cell carcinoma of the head and neck - Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy with S-1 after curative treatment in patients with squamous cell carcinoma of the head and neck

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021137

Enrollment

Registered

2016-02-22

Start date

2016-03-02

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

Head and Neck squamous cell carcinoma

Interventions

S-1: 40, 50, 60mg/m2 PO bid (morning and evening) for 2 weeks with 1 weeks rest Lafutidine: 10mg/body PO bid (morning and evening) everyday In total of 1 year after curative treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histological proven squamous cell carcinoma of the head and neck 2) Primary site, maxillary sinus, oral cavity, oropharynx, hypopharynx or larynx 3) Initial definitive treatment (surgery treatment and radiation therapy) is carried out clinical or pathological stage Stage3 or Stage4A, 4B cases. 4) Initial curative treatment after the end of three months the tumor within patients (primary tumor and lymph node metastases) disappearance has been confirmed 5)Not chemotherapy in the period leading up to registration from after the initial curative treatment end 6) Age 20-75 years 7) Performance status (PS) 0-1 8) Patient can start administration of S-1 within 3 months after Initial definitive treatment. 9) Adequate organ functions defined as indicated below (1)WBC >= 3,500 /mm3 , WBC <= 12,000 /mm3 (2)neutrophil >= 1,500 /mm3 (3)Plt >= 100,000 /mm3 (4) Hb>= 9.0 g/ dL (5) T.Bil <= 1.5 mg/dL (6) AST(GOT) , ALT(GPT) <= 100 IU/L (7) Cr < 1.2 mg/dL 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patient with active double cancer (synchronous double cancer and metachronous double cancer) 2) Patient with administration contraindication of S-1 and Lafutidine

Design outcomes

Primary

Measure	Time frame
Completion rate of S-1 treatment according to planned	—

Secondary

Measure	Time frame
1) safety 2) Medication compliance	—

Countries

Japan

Contacts

Public ContactIsaku Okamoto, MD

Tokyo medical university otolaryngology

isaku@tokyo-med.ac.jp03-3342-6111

Outcome results

None listed

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