Phase III Trial Comparing Conventional RT With Concomitant CT Versus Accelerated RT With Concomitant CT Versus Very Accelerated RT Alone in Patients With 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
- 840
- 试验地点
- 2
- 主要终点
- Event free survival (event=progression, relapse, death from any cause)
研究概览
简要总结
This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.
详细描述
This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant chemotherapy (arm B) versus very accelerated radiotherapy alone (arm C) in patients with stage III-IV head and neck squamous cell carcinoma (HNSCC). The main end point is the event free survival.
The treatments are
Bras A : Conventional radiotherapy given once daily, delivering 70 Gy in 7 weeks (5 fractions of 2 Gy per week) and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-4 and D22-25 and D43-46
Bras B: middle accelerated radiotherapy delivering 70 Gy in 6 weeks and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-5 and D29-33
- first part : radiotherapy given once daily delivering 40 Gy in 4 weeks and 20 fractions of 2 Gy
- second part : radiotherapy given twice daily with "concomitant boost" delivering 30 Gy in 20 fractions in 2 weeks (1,5 Gy x 2 / day)
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
- 20 Years 至 75 Years（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, hypopharynx or larynx
- •Stage III-IV (UICC 1997): T2, T3 or T4 with N0-N3 or T0 with N2-N3
- •Not resectable
- •Karnofsky PS >= 70
- •Renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-FU
- •Informed consent signed
排除标准
- •Distant metastasis
- •Contra-indication to concomitant chemotherapy
- •History of cancer
- •History of head and neck radiotherapy
研究组 & 干预措施
1
干预措施: Conventional radiotherapy 70 Gy in 7 weeks (Procedure)
1
干预措施: 5FU, Paraplatin (Drug)
2
干预措施: middle accelerated radiotherapy 70 Gy in 6 weeks (Procedure)
2
干预措施: 5FU, Paraplatin (Drug)
3
干预措施: very accelerated radiotherapy 64.8 Gy in 3.5 weeks (Procedure)
结局指标
主要结局
Event free survival (event=progression, relapse, death from any cause)
时间窗: 3 years
次要结局
- Survival(3 years)
- Loco regional control(3 years)
- Toxicity(early and late)