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临床试验/NCT07197060
NCT07197060尚未招募不适用

Hypofractionated Radiotherapy With 3.5 Gy Per Fraction for Early Glottic Cancer

Assiut University0 个研究点目标入组 70 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
local control rate

研究概览

简要总结

Early-stage glottic carcinoma (T1-T2N0M0) is typically managed with either transoral laser microsurgery or definitive radiotherapy, both providing excellent local control rates and voice preservation outcomes. Radiotherapy remains a widely adopted non-invasive option, particularly for patients with bilateral disease or poor surgical candidacy. Traditionally, conventional fractionation schemes of 2.0-2.25 Gy per fraction over 6-7 weeks have been standard; however, emerging evidence supports the use of hypofractionated radiotherapy (HFRT) as an effective and more convenient alternative in this setting.

The unique anatomical confinement of early glottic tumors, along with their low propensity for lymphatic spread, makes them ideal candidates for dose escalation using hypofractionation. Several retrospective and prospective studies have demonstrated that higher doses per fraction (2.5-3.5 Gy) can yield comparable or superior local control rates compared to conventional regimens, without significantly increasing toxicity. The incorporation of modern techniques such as Intensity Modulated RadioTherapy (IMRT) and Simultaneous Integrated Boost (SIB) has further.enabled safe and precise delivery of escalated doses to the primary lesion while sparing nearby organs-at-risk (OARs)

Recent data have shown that a 3.5 Gy per fraction regimen (totaling 59.5 Gy in 17 fractions) achieves excellent tumor control with favorable toxicity profiles in selected patients. Additionally, omission of the posterior commissure from the elective target volume in the absence of direct tumor extension has been associated with reduced mucosal toxicity and improved patient-reported outcomes. Therefore,hypofractionated RT using 3.5 Gy per fraction offers a promising voice-preserving strategy in the treatment of early glottic cancer

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Histologically confirmed squamous cell carcinoma of the glottis
  • Stage T1-T2N0M0 (AJCC 8th edition)
  • (based on clinical exam and imaging)
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • No prior radiotherapy or surgery to the larynx (except biopsy)
  • Adequate organ function and a life expectancy of at least 6 months
  • Ability to comply with follow-up schedule and complete voice assessments
  • Signed informed consent

排除标准

  • • Prior head and neck irradiation
  • Nodal involvement or distant metastasis
  • Poor vocal cord mobility or subglottic extension
  • Severe comorbidities or life expectancy < 6 months

结局指标

主要结局

local control rate

时间窗: 2-year

local control rate

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manar Tarek mohamed

residant doctor at Assiut university hospital

Assiut University

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