跳至主要内容
临床试验/CTRI/2021/08/036041
CTRI/2021/08/036041尚未招募2/3 期

A quasi-experimental study comparing dysphagia optimized intensity modulated radiotherapy (Do-IMRT) versus standard intensity modulated radiotherapy (S-IMRT).

Karthik Subramaniam Thiagarajan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年6月9日最近更新:

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)

研究者

发起方
Karthik Subramaniam Thiagarajan
申办方类型
Other [self]

研究点 (1)

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