NCT00147732已完成3 期
A Multicentre, Randomised, Phase III Clinical Trial Comparing Accelerated Radiotherapy With Accelerated Radiotherapy Plus Carbogen and Nicotinamide (ARCON) in Clinical Stage T2-4 Laryngeal Carcinoma.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 345
- 试验地点
- 8
- 主要终点
- Local control
研究概览
简要总结
TITLE:
A multicentre, randomised, phase III clinical trial comparing accelerated radiotherapy with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in clinical stage T2-4 laryngeal carcinoma.
PRIMARY OBJECTIVE:
Does the addition of carbogen and nicotinamide to a schedule of accelerated radiotherapy in patients with clinical stage T2-4 laryngeal carcinoma improve local primary tumour control? Definitive analysis will be performed on local control rates at two years after completion of radiotherapy.
SECONDARY OBJECTIVES:
Does the addition of carbogen and nicotinamide
- increase the larynx preservation rate?
- increase the regional control rate?
- increase the toxicity of accelerated radiotherapy?
- improve the overall quality of life?
- improve the disease-free survival?
- improve the overall survival?
STUDY DESIGN:
An open-label, randomised clinical trial assigning patients in a 1:1 ratio to one of the following treatment arms:
- accelerated radiotherapy
- accelerated radiotherapy plus carbogen and nicotinamide
PATIENT CHARACTERISTICS AND NUMBER:
344 patients with clinical T2-4 laryngeal carcinoma
MEASUREMENTS:
- time to local failure
- time to regional failure
- survival with functional larynx
- overall and disease-free survival
- frequency and severity of complications related to radiotherapy and carbogen and nicotinamide
- quality of life assessment
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological confirmed squamous cell carcinoma of the larynx.
- •TNM-classification (UICC 1997, appendix I):
- •T3-4 glottic or supraglottic carcinoma
- •T2 glottic carcinoma with impaired cord mobility or subglottic extension
- •T2 supraglottic carcinoma with invasion of mucosa of base of tongue or vallecula or invasion of the medial wall of the piriform sinus.
- •any N-stage, M
- •WHO performance status 0 or 1 (appendix II).
- •Age > 18 years.
- •Written informed consent.
- •Quality of life questionnaire completed.
排除标准
- •Prior or concurrent treatment for this tumour.
- •Severe stridor and adequate debulking of airway not possible.
- •Impaired renal function: serum creatinine above upper normal limit.
- •Use of nefrotoxic medication (including ACE-inhibitors) that cannot be discontinued for the duration of the radiation treatment.
- •Impaired hepatic function: ASAT and ALAT more than 1.5 times the upper normal limit.
- •Use of anti-convulsants that cannot be discontinued for the duration of the radiation treatment.
- •History of malignancy during the previous 5 years except basal cell carcinoma of skin, carcinoma in situ of the cervix, or superficial bladder neoplasm (pTa).
结局指标
主要结局
Local control
时间窗: 2 years
次要结局
- regional control rate(2 years)
- toxicity(5 years)
- quality of life(2 years)
- disease-free survival(5 years)
- improve the overall survival(5 years)
- larynx preservation(2 years)
研究者
研究点 (8)
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