Randomized Phase III Trial Comparing Induction Chemotherapy Followed by Radiotherapy to Concomitant Chemoradiotherapy for Laryngeal Preservation in T3MO Pyriform Sinus Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 7
- 主要终点
- The primary end point was to compare the two treatment arms to define the best schedule of preservation of an intact larynx.
研究概览
简要总结
Patients were eligible if they had biopsy proven, previously untreated T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus.
The study compare conventional radiotherapy with concurrent cisplatin to induction chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary end point was the preservation of the larynx. The secondary end points included toxicity, causes of death and survival rates.
详细描述
Objectives: To compare conventional radiotherapy with concurrent cisplatin to induction chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary end point was the preservation of the larynx. The secondary end points included toxicity, causes of death and survival rates.
Design: Multicenter prospective randomized phase III trial. Setting: Academic tertiary care center. Patients: Seventy one adult patients with biopsy-proven previously untreated resectable T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus.
Main Outcomes Measures: Patients were evaluated for toxic reactions, and organ preservation and survival rates. Statistical analysis of overall survival and event free survival was performed using the Kaplan Meier method.
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
- •Patients were eligible if they had biopsy proven, previously untreated T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus.
- •Patients also had to have a performance status (PS)< 1, and normal organ functions as defined by an absolute neutrophil count > 1500 cells/microl, platelet count > 100 000 cells/microl and a calculated creatinine clearance of more than 50 ml/min.
排除标准
- •Patients with T1, T2 or T4 or M1 (metastatic disease) were ineligible.
研究组 & 干预措施
1
Cisplatin was administered intravenously at a dose of 100 mg/m2 on day 1 and fluorouracil was administered at a dose of 1 000 mg/m2/day by continuous intravenous infusion on day 1 to 5 for 2 courses after 3 weeks. After induction chemotherapy patients underwent ears, nose and throat examination and computed tomography imaging.
干预措施: induction chemotherapy (Procedure)
2
Intravenous cisplatin at dose of 100 mg/m2 on days 1, 22 and 43 was administered concomitantly with conventional radiotherapy to the primary tumor and to the neck lymph nodes according to the pathological findings of the pre-treatment neck dissection at a total dose of 70 Gy.
干预措施: Conventionnal chemotherapy (Procedure)
结局指标
主要结局
The primary end point was to compare the two treatment arms to define the best schedule of preservation of an intact larynx.
时间窗: 2 years
次要结局
- Secondary end points analyzed causes of death, overall survival rate and event (loco-regional recurrent disease, metastases, death) free survival rate.(2 years)