Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- progression free survival
研究概览
简要总结
Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. The overall incidence of HNC continues to rise, with a predicted 30% increase annually by 2030., this increase has been recorded across both developed and developing countries.
Approximately 90% of HNCs are squamous cell carcinoma . The major risk factors of head and neck squamous cell carcinoma (HNSCC) are tobacco and heavy alcohol use and human papillomavirus infection . There has been a significant decline in smoking in high-income countries during the last few decades, which has led to a sharp decline in smoking related HNSCC . While increase in global incidence of human papillomavirus (HPV)-associated or positive (+) HNSCC Head and neck squamous cell carcinoma (HNSCC) is a highly challenging cancer, despite the advancements in treatment, the overall prognosis for HNSCC remains poor, with a five-year survival rate of around 50%.
Chemoradiation is one of the treatment options for locally advanced head and neck cancers, the drug of choice for radiosensitization is cisplatin Although cisplatin-based chemoradiotherapy (CRT) is the standard of care for locally advanced head and neck squamous cell carcinoma (LAHNSCC), cisplatin is contraindicated in many patients because of age, diminished renal functions and hearing loss so docetaxel studied as an alternative radiosensitizer in this group.
The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.
详细描述
History: age, gender, comorbidities and risk factors.
Baseline evaluation of the patients:
CT or MRI head and neck Endoscopy and biopsy will be taken. Laboratory: CBC, renal functions and liver functions Nutritional assessment Audiogram as baseline assessment Dental assessment
Our patients will receive docetaxel (15 mg per meter squared) once weekly concurrently with radiotherapy.
Follow up of the patient during the course of treatment including evaluation of the patients weekly to assess the adverse events in the form of skin toxicity, mucositis, neutropenia and renal function affection.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 18 years
- •Pathologically proven of squamous cell carcinoma
- •Patients with locally advanced disease (T3, T4)(N positive)
- •Patients eligible for radiotherapy
排除标准
- •Patients with metastatic disease
- •Patients with second primary cancer
- •Patients ineligible for radiotherapy
结局指标
主要结局
progression free survival
时间窗: 2 years
Progression free survival defined as the average length of time after the start of treatment in which a person is alive and their cancer does not grow or spread
次要结局
- incidence of treatment adverse events(2 years)
- Overall survival (OS)(2 years)
研究者
Rehab Osama Abdelmaboud
assistant lecturer
Assiut University