Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- Loco regional control
研究概览
简要总结
This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.
详细描述
This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.
The IMRT total dose is 75 Gy (50 Gy to PTV1 and T0 + 25 Gy (10 fractions) to PTV2). The conventional radiotherapy total dose is 70 Gy (50 Gy to PTV1 + 20 Gy (10 fractions) to PTV2). In both arms, the cervical nodes will receive 50 Gy (65 Gy in case of Np) by conventional radiotherapy (IMRT is allowed in the IRMT arm). In the two arms, patients will receive concomitant cisplatin (100 mg/m² D1, D21, D42).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •squamous cell carcinoma of oral cavity, oropharynx or hypopharynx
- •Stage III - IV (T1-T4, N0-N2)(UICC 2002)
- •Not resected
- •Indication of radiotherapy to bilateral cervical nodes at dose>= 50 Gy
- •Delineation of target volumes done before randomization
- •Scintigraphy of parotid gland done before radiotherapy start
- •Quality of life questionnaires (EORTC-C30 and EORTC-H&N35) filled in by the patient
- •Informed consent signed
排除标准
- •N3 (UICC 2002)
- •Distant metastasis
- •Contra-indication to concomitant cisplatin
- •History of cancer within the last 5 years
- •History of head and neck radiotherapy
- •Administration of drugs for treatment or prophylaxis of xerostomia (pilocarpine, ethyol)
研究组 & 干预措施
1
Conventional RT 70Gy + concomitant cisplatin
干预措施: Conventional radiotherapy 70 Gy (Procedure)
1
Conventional RT 70Gy + concomitant cisplatin
干预措施: concomitant cisplatin (Drug)
2
IMRT 75Gy + concomitant cisplatin
干预措施: IMRT 75 Gy (Procedure)
2
IMRT 75Gy + concomitant cisplatin
干预措施: concomitant cisplatin (Drug)
结局指标
主要结局
Loco regional control
时间窗: 2 years
次要结局
- Survival(2 years)
- Xerostomia at 2 years (evaluated by parotid gland scintigraphy)(2 years)
- Quality of life (EORTC-QLQ-H&N35)(2 years)