Prospective, Multicenter, and Nonrandomized Phase II Clinical Study on the Treatment of Locally Advanced NPC By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- National Cancer Institute CTCAE v4.0
研究概览
简要总结
This study is aimed to investigate the short-term efficacy and toxicities of local advanced nasopharyngeal carcinoma (NPC) treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and cisplatin concurrent chemoradiotherapy.
详细描述
TPF program is currently the local advanced nasopharyngeal carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin， direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients.In this study, Phase II clinical trials were performed. Patients with locally advanced local advanced nasopharyngeal carcinoma were nonrandomly divided into experimental group and control group.The trial group was treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and chemotherapy. The control group was treated with TPF regimen induction chemotherapy combined with Cisplatin concurrent radiotherapy and chemotherapy.observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The pathological type is non-keratinizing cancer (according to the World Health Organization, WHO pathological classification).
- •The stage is graded by TxNxM0 (according to the eighth edition of the AJCC staging standard).
- •Age: Between 18 to
- •EGFR, which is performed by biopsy immunohistochemical examination, shows positive.
- •Functional Status: Karnofsky Scale (KPS) >
- •Normal Bone Marrow Function: White blood cell count > 4×109/L, hemoglobin >90g/L, and platelet count >100×109/L.
- •Normal Liver Function: Alanine Tminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5 times the upper limit of normal (ULN), while alkaline phosphatase (ALP) < 2.5 x ULN and bilirubin < ULN.
- •Normal Renal Function: creatinine clearance > 60 ml/min.
- •The patient must be informed of the basic content of the study and sign an informed consent.
排除标准
- •Patients with a prior history of malignant tumors, except well-treated basal cell carcinoma or squamous-cell carcinoma, and cervical carcinoma in situ.
- •Women during pregnancy or breastfeeding (for women of child-bearing age, pregnancy test should be considered; effective contraception should be emphasized during treatment).
- •Patients received radiotherapy, chemotherapy, and immunological targeted therapies (non-melanoma skin cancers with previous lesions outside the target of radiotherapy are excluded).
- •Patients received treatments for primary lesions and metastatic cervical lesions (except diagnostic treatment).
- •Patients with other serious diseases which may bring greater risk or affect the compliance of the trial. For example: unstable heart disease requiring treatment, kidney disease, chronic hepatitis, uncontrolled diabetes (fasting blood glucose >1.5 x ULN), and mental illness.
研究组 & 干预措施
the treatment group
TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy
干预措施: Nimotuzumab (Drug)
the control group
TPF regimen induction chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy
干预措施: Cisplatin (Drug)
结局指标
主要结局
National Cancer Institute CTCAE v4.0
时间窗: 1 year
Acute toxicity of radiotherapy and chemotherapy
次要结局
- locoregional failure-free survival(5 years)
- progression-free survival(5 years)
- overall survival(5 years)
- evaluation of immediate efficacy overall survival overall survival overall survival overall survival overall survival overall survival(1 year)
研究者
Feng Jing
Head and neck cancer director, chief researcher, clinical professor
Guiyang Medical University