New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
To develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. Experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. Thus to achieve a better survival rate and a higher larynx-preservation rate as well as a lower treatment related toxicity rate compared with standard treatment.
详细描述
Eligiblity patient were assign to induction chemotherapy plus concurrent chemotherapy group (IC +CCRT group, Arm A)and concurrent chemoradiotherapy group(CCRT group, Arm B). For patients in Arm A, treatment response were evaluated after 2cycles, if the response reached partial response/complete response, patients received concurrent chemoradiotherapy, otherwise, patients will received surgery and radiotherpay/concurrent chemoradiotherapy after surgery. For patients received concurrent chemoradiotherapy (both in Arm A and Arm B) , treatment response were evaluated at 50 Gy. if response reached complete response or major partial response(>80% tumor regression), patients will received radical chemoradiotherapy, otherwise, patients will received surgery.
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
- None
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
- •Histologically proven squamous cell carcinoma of hypopharynx
- •Stage III/IV M0, with T3/4 N0-3 or T1-4 N2-3
- •Karnofsky Performance Status>=70
- •Have measurable lesions on CT/MRI
- •Treatment for the first time
- •Expected lifetime > 6 months
- •Normal blood test, hepatic and renal functions
- •Normal hearing
- •Can understand and sign the consent
- •Have follow up condition
排除标准
- •Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- •Previously treatment for cancer
- •Pregnant or breeding woman, female without contraception
- •Enrolling in other drug trials
- •Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
- •Without follow up
- •Receive target therapy
研究组 & 干预措施
Concurrent chemoradiotherapy group
Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy
干预措施: Concurrent CRT group (Radiation)
Induction chemotherapy and concurret chemoradiotherapy group
Patients receive 2 cycles of paclitaxel, cisplatin and 5-Fluorouracil chemotherapy followed by Surgery or Chemo-radiotherapy according to the response status after induction chemo.
干预措施: Induction CT+ CRT group (Drug)
结局指标
主要结局
overall survival
时间窗: 5 year
次要结局
- disease free survival(5 year)
- larynx-preservation rate(5 year)
- treatment related toxicities(2 year)
- distant-metastasis free survival(5 year)
研究者
Jun-Lin Yi, MD
Professor
Chinese Academy of Medical Sciences