Phase II multicenter trial of platinum-cetuximab combined with docetaxel or with 5FU for Japanese patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

Phase II multicenter trial of platinum-cetuximab combined with docetaxel or with 5FU for Japanese patients with recurrent/metastatic squamous cell carcinoma of the head and neck. - TEMPER study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025436

Enrollment

180

Registered

2017-03-01

Start date

2017-10-01

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

recurrent/metastatic squamous cell carcinoma of the head and neck

Interventions

Arm A: modified PFE Cisplatin 75 mg/m2/day1/every 3 weeks 5FU 750 mg/m2/day1-5/every 3 weeks up to 6 cycle Cetuximab loading dose 400mg/m2/day1, followed by 250mg/m2/week, until disease progressio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed recurrent or metastatic squamous cell carcinoma of head and neck (excluding nasopharynx and salivary grand) 2) Obtained tumoral tissues from oropharyngeal carcinoma patients at baseline for p16 status 3) At least one bidimensionally measurable lesion (RECIST ver.1.1) by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days from date of registration 4) ECOG performance status (PS) of 0 or 1 5) Aged 20 years or more 6) Aequate organ functions Neutrophil >= 1,500/mm3 Platelet >= 100,000/mm3 Hemoglobin >= 9.0g/dL T-bilirubin <= 2.4 mg/dL Creatinin clearance >= 60 mL/min AST or ALT <= 100U/L 7) Life expectancy of greater than 3 months 8) Women of child-bearing potential and men who are able to father a child agree with using adequate contraception 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Prior systemic chemotherapy (expect as part of a multimodal therapy for locally advaneced disease > 6 months before the trial entry) 2) Prior dose of cisplatin > 300 mg/m2 3) Prior surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before registration 4) Simultaneous or metachronous (within 3 years) double cancers (excluding superficial cancer that will be cured by endoscopic mucosal resection) 5) Symptomatic brain metastasis 6) Severe myelosuppression or infections 7) Pulmonary fibrosis, acute lung injury or Intestinal pneumonia 8) Severe and uncontrolled complication (heart failure, pulmonary fibrosis, renal failure, hepatic failure, uncontrolle diabetes mellitus or uncontrolled hypertension) 9) Known hypersensitivity against any components of the trial treatment including excepients 10) Pregnancy or breast feeding 11) Receiving other concomitant anti tumor therapy 12) Previous treatment with cetuximab or monoclonal antibody 13) Positive HBs antigen 14) Decision of ineligibility by a physician

Design outcomes

Primary

Measure	Time frame
progression-free survival	—

Secondary

Measure	Time frame
objective responce rate adverse events overall survival	—

Countries

Japan

Contacts

Public ContactMotoyuki Suzuki

TEMPER study Coordinating Office Department of Otorhinolaryngology-Head & Neck Surgery, Osaka University Graduate School of Medicine

msuzuki@ent.med.osaka-u.ac.jp06-6879-3951

Outcome results

None listed

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