A Prospective Phase II Randomized Clinical Trial: Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Lobaplatin Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 144
- 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 to observe and compare the safety and tolerability of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma.
详细描述
TPF program is currently the local advanced head and neck squamous cell 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. Therefore, how to improve the efficacy of the same time to reduce adverse drug reactions, as a prominent problem. Lobaplatin as the third generation of platinum antitumor drugs, anti-cancer activity and cisplatin rather, more than carboplatin. In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent 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
- 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
- •Voluntary participation and written informed consent
- •Age 18-70 years old, gender is not limited
- •histologically proved to be squamous cell carcinoma
- •No surgery: head and neck squamous cell carcinoma 2010UICC staging Ⅲ - ⅣA, ⅣB period.
- •After surgery: 2010UICC staging ⅣA, ⅣB;stage III tongue base or hypopharyngeal primaries;Postoperative naked eye or image residual stage III patients
- •Karnofsky score ≥70
- •Survival is expected to be ≥ 6 months
- •Women of childbearing age should be guaranteed contraception during the study period
- •(WBC) ≥4 × 109 / L * (unit normal), platelet (PLT) ≥100 × 109 / L (unit normal value), neutrophil cell (WBC), hematocrit (WBC) ≥1.5 × 109 / L * (unit normal value)
- •liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) <upper limit of normal (ULN) 1.5 times; total bilirubin <1.5 × ULN
- •renal function: serum creatinine <1.5 × ULN, endogenous creatinine clearance rate (Ccr) ≥ 55 ml / min
- •no serious complications such as hypertension, diabetes, coronary heart disease and psychiatric history
- •The treatment for the first course of treatment (no head and neck radiotherapy, no chemotherapy within 3 months).
排除标准
- •There is a distant shift
- •primary lesions or lymph nodes were radiotherapy
- •had received epidermal growth factor targeted therapy
- •primary tumor had received chemotherapy or immunotherapy
- •had other malignancies (except for cured basal cell carcinoma or cervical cancer)
- •pregnant women or lactating women and treatment during the observation period of contraceptive women of childbearing age
- •have a serious history of allergies or specific physical
- •Abuse of drugs or alcohol addicts
- •Person who has personality or mental illness, no civil capacity or limited civil capacity
研究组 & 干预措施
the treatment group
docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy
干预措施: Lobaplatin (Drug)
the control group
TPF induction chemotherapy combined with cisplatin 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
evaluation of immediate efficacy
时间窗: 1 year
Evaluation of efficacy by RESIST1.1 standard
次要结局
- progression-free survival(5 years)
- overall survival(5 years)
研究者
Feng Jing
Head and neck cancer director, chief researcher, clinical professor
Guiyang Medical University