Palliative Radiotherapy for Advanced Head and Neck Carcinomas, a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Quality of life
研究概览
简要总结
Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected.
详细描述
Patients deemed too frail for radical treatment or incurable because of tumour extension, as determined by an experienced tumour board, were eligible for this study of palliative radiotherapy delivered by intensity modulation, 25 Gy in 5 daily fractions over one week. This study was conducted in two academic centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Able to give an informed consent
- •Able to complete QOL questionnaires
- •Deemed incurable by an experienced tumour board or unwilling to receive a radical course of radiation therapy
- •Presence of measurable disease
- •Biopsy proven squamous or salivary cancer of the head and neck region
- •Expected survival of at least 2 months.
排除标准
- •Pregnancy
- •No previous RT to the neck and no plan to receive concomitant chemotherapy
- •Special histology (Lymphoma, small cell cancer, metastasis from a site other than the head and neck region)
- •Unavailable for follow-up
结局指标
主要结局
Quality of life
时间窗: from radiation treatment until 24 months planned follow-up or death
EORTC QLQ-C30 questionnaire (QLQ-C15-PAL and H\&N35 modules)
次要结局
- Toxicity (CTCAE v 4.0 graded)(from radiation treatment until 24 months planned follow-up or death)
研究者
Bernard Fortin MD MSc FRCPC
principal investigator
Maisonneuve-Rosemont Hospital