JPRN-jRCTs071180009已完成2 期
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
Inohara Hidenori0 个研究点目标入组 61 人开始时间: 2018年11月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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