NCT01864850已完成3 期
Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma
Groupe Oncologie Radiotherapie Tete et Cou4 个研究点 分布在 2 个国家目标入组 202 人开始时间: 2013年10月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 4
- 主要终点
- Locoregional control
研究概览
简要总结
Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 70 or over
- •SIOG group 2 (vulnerable)
- •Life expectancy > 12 weeks
- •Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary).
- •First line treatment
- •At least one measurable lesion (RECIST)
- •Stage II to IV
- •Patients unsuitable for surgery of the primary tumour: non resectable tumor, anesthesia contra indication, patient's refusal, or organ sparing approach. Cervical nodes dissection authorized
- •Patients planned to be treated in a curative intent with radiotherapy alone on primary tumor site and on at least one head and neck node area
- •Consent form signed
排除标准
- •Primary squamous cell carcinoma of sinus, the skin or of the salivary glands
- •Stage I cancer
- •Radiotherapy planned on primary tumor only, or on neck nodes only. For patients with metastatic lymph nodes from unknown primary head and neck squamous cell carcinoma, patients will be excluded if head and neck mucosa (oropharynx, larynx, hypopharynx) is not included as a target volume for radiotherapy
- •Prior radiotherapy of head and neck area
- •Concurrent chemotherapy or immunotherapy or hormonotherapy
- •Induction chemotherapy
- •Concomitant infection requiring IV antibiotics
- •cancer other than head and neck cancer within the previous 5 years (baso cellular skin carcinoma and cervix carcinoma excepted)
- •conditions that could lead to bad compliance
结局指标
主要结局
Locoregional control
时间窗: 6 months
Patient alive with locoregional control at 6 months after the end of radiotherapy
次要结局
- Acute toxicity(3 months)
- Late toxicity(18 months)
- Health related quality of life(18 months)
- Locoregional progression(18 months)
- metastasis progression(18 months)
- Autonomy(18 months)
- Overall survival(18 months)
- Progression free survival(18 months)
研究者
研究点 (4)
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