TEMPER Study

Phase 2

• Conditions: Recurrent or metastatic squamous cell carcinoma of head and neck

• Registration Number: JPRN-jRCTs071180009
• Lead Sponsor: Inohara Hidenori

Brief Summary

It was confirmed that mTPEx therapy has a survival rate comparable to that of mPFE therapy, and that the first-line prophylactic administration of G-CSF is sufficiently safe. It also has a very high response rate and a transition to second-line treatment, and may be an option as the 1st line chemotherapy for R/M HNSCC.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-29
• Study Completion: 2021-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 61

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 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

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified