TEMPER Study

JRCT ID: jRCTs071180009

Registered date:29/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Recurrent or metastatic squamous cell carcinoma of head and neck
• Date of first enrollment: 01/11/2017
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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 progression
Arm B: modified TPEx
Cisplatin 60 mg/m2/day1/every 3 weeks
Docetaxel 60mg/m2/day1/every 3weeks
up to 4 cycle
Cetuximab loading dose 400mg/m2/day1, followed by 250mg/m2/week, until disease progression

Primary prophylactic administration of GCSF must be administered systematically after each cycle of chemotherapy

Outcome(s)

• Primary Outcome: progression-free survival

Secondary Outcome

objective responce rate
adverse events
overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 40 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

Exclude 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 double cancers which the investigator judges to influence the enforcement of protocol treatment and prognosis of primary disease(excluding such as 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 within 6 months before registration
13) Positive HBs antigen
14) Decision of ineligibility by a physician

Related Information

• Primary Sponsor: Inohara Hidenori
• Source(s) of Monetary Support: Merck Biophama Co., Ltd