NCT00865098已完成2 期
Open-label, Non-randomized, Non-controlled, Multicenter Phase II Study Investigating Cetuximab in Combination With Concomitant-boost Radiotherapy as First-line Treatment for Japanese Patients With Newly Diagnosed Locally Advanced SCCHN.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Completion Rate
研究概览
简要总结
This study is conducted in Japanese newly diagnosed locally advanced SCCHN patients in order to assess tolerability and feasibility of Cetuximab plus concomitant boost radiotherapy (RT) regimen (the study treatment) and its safety profile (i.e. AEs: adverse events). In addition, efficacy (i.e. anti-tumor effect) of the study treatment is also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has pathologically proven squamous cell carcinoma arising in the oropharynx, hypopharynx, or larynx.
- •The patient has been confirmed Epidermal Growth Factor Receptor expressing in tumor specimen by immunohistochemistry.
- •The patient has stage III or IV disease (Unio Internationalis Contra Cancrum / International Union against Cancer Tumor-Lymph Nodes-Metastases classification) with an expected survival of ≥ 12 months.
- •The patient has at least bi-dimensionally measurable disease.
- •The patient is medically suitable to withstand a course of the definitive radiation therapy.
- •The patient aged ≥ 20 years old at informed consent
- •The patient's Karnofsky performance status is ≥ 60
- •Hemoglobin ≥ 9g/dL
- •Neutrophil ≥ 1500/mm^3
- •Platelet ≥ 100,000/mm^3
- •Total Bilirubin ≤ 1.5 mg/dL
- •Aspartate Aminotransferase ≤ 2 x the upper limit of normal
- •Alanine Aminotransferase ≤ 2 x the upper limit of normal
- •Serum creatinine ≤ 1.5 mg/dL
- •Serum calcium concentration: within normality
- •The patient is eligible if disease free from a previously treated malignancy for greater than three years.
- •The patient agrees to use effective contraception if procreative potential exists.
- •The patient has given signed informed consent
- •The patient who is a Japanese with Japanese citizenship
排除标准
- •The patient has evidence of distant metastatic disease. The patient who has any metastatic disease documented by Magnetic Resonance Imaging for the head and neck, and Computed Tomography for the chest and abdomen should be excluded.
- •The patient has squamous cell carcinoma arising in the nasopharynx or oral cavity.
- •The patient has received prior systemic chemotherapy within the last three years.
- •The patient has undergone previous surgery for the tumor under study other than biopsy.
- •The patient has received prior radiation therapy to the head and neck.
- •The patient's radiation therapy is considered to be a part of a postoperative regimen following primary surgical resection.
- •The patient is pregnant or breast feeding.
- •The patient has received prior Cetuximab or murine monoclonal antibody (including chimeric antibody) therapy or a history of severe hypersensitivity to any component of Cetuximab solution for Injection.
- •The patient has a medical or psychological condition that would not permit the patient to complete the study or sign informed consent (including drug abuse).
- •The patient has uncontrolled diabetes mellitus, malignant hypertension, or liver failure.
- •The patient has or has suffered from a pulmonary fibrosis, acute pulmonary disorder, or interstitial pneumonia.
- •The patient has an active infection (infection requiring intravenous anti-bacterial, anti-fungus, or anti-viral agent), or known and declared Human Immunodeficiency Virus infection.
- •The patient has a clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
- •The patient has a dental disease which requires incision and drainage.
- •The patient has active multiple cancers (excluding skin cancer except for melanoma, and carcinoma in situ of the cervix or the digestive tract) in the last 3 years.
- •The patient has been received some investigational medication within 30 days before study entry.
研究组 & 干预措施
Cetuximab With Radiotherapy
Experimental
干预措施: Cetuximab (Drug)
结局指标
主要结局
Completion Rate
时间窗: time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks
Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population
次要结局
- Best Response Rate(best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was required)
- Safety - Number of Patients Experiencing Any Adverse Event(time from first dose up to 60 days after last dose of study treatment, ≤18 weeks)
- Safety - Number of Patients Experiencing Any Grade 4 Adverse Event(time from first dose up to 60 days after last dose of study treatment, ≤18 weeks)
- Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction(time from first dose up to 60 days after last dose of study treatment, ≤18 weeks)
- Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction(time from first dose up to 60 days after last dose of study treatment, ≤18 weeks)
研究者
研究点 (1)
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