A quasi-experimental study comparing dysphagia optimized intensity modulated radiotherapy (Do-IMRT) versus standard intensity modulated radiotherapy (S-IMRT).
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Severity of dysphagia
研究概览
简要总结
Dysphagiafollowing chemoradiation for patients with head and neck cancers have led to adevastating impact on their quality of life, as it leads to a change in thetype of diet, prolongation of meal times, or even a need for tube feeding. Althoughother significant toxicities have been reduced by developments in radiationtechniques, dysphagia continues to be a challenge for radiation oncologists. Manyphase II studies have shownthat reducing the radiation dose to critical swallowing structures such as thepharyngeal constrictor muscle and supraglottic larynx can lead to betteroutcomes; however, there are limited prospective studies to have verified thisbenefit. The aim of this study is to compare the effects of standard intensitymodulated radiotherapy (S-IMRT) and dysphagia-optimized intensity modulatedradiotherapy (Do-IMRT) on severity of dysphagia aswell as immediate treatment response in patientsundergoing concurrent chemoradiation for oropharyngeal, hypopharyngeal, andsupraglottic laryngeal cancer (T2-T4, N+, M0). The swallowingfunction will be assessed by means of a modified barium swallow techniqueperformedsix months aftertreatment and the treatment response will be assessed by comparing the PET-CTscan taken six months aftertreatment with the pre-treatment PET-CT scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with stage T2-T4, N+, M0 carcinoma of oropharynx, hypopharynx or larynx with squamous cell carcinoma histology only 2) ECOG performance 0-2 3) Written informed consent.
排除标准
- •• Patients with head and neck cancer with non-squamous cell carcinoma histology • Cancer sites other than oropharynx, hypopharynx, or supraglottic larynx • Patients with T1 N0 M0 (or M1) disease in the above-mentioned sites • Patients with recurrent cancer in the above-mentioned sites • Patients not fit for concurrent chemoradiation (or receiving chemotherapy other than weekly cisplatin) • Documented evidence of pre-existing swallowing dysfunction (not related to cancer) • Previous radiotherapy to the head and neck region • ECOG performance 3-4.
结局指标
主要结局
Severity of dysphagia
时间窗: 3 months post radiation
次要结局
- Treatment response(Comparison of pre-treatment PET-CT scan with post-treatment PET-CT scan)
