跳至主要内容
临床试验/CTRI/2025/05/087040
CTRI/2025/05/087040尚未招募不适用

Ascertaining the impact of adjuvant radiotherapy in early stage risk factor positive oral cavity squamous cell carcinoma and evaluating patterns of failureA project of theYoung Investigators Committee under the auspices of the Head and Neck Inter Group

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2025年6月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,500
试验地点
1
主要终点
Overall Survival between radiation and no radiation groups.

研究概览

简要总结

The purpose of this retrospective study is to investigate the difference in disease outcomes of patients who were treated with surgery plus adjuvant radiotherapy versus surgery alone for early-stage oral cavity squamous cell carcinoma (OC-SCC) with various risk factors. Currently, surgery is often used as the sole treatment modality of choice for patients with stage I and II OC-SCC. However, certain poor pathological features, such as higher worst pattern of invasion (WPOI), perineural invasion, and lymphovascular invasion, are associated with worse tumor biology and increase the risk of local recurrence, even in the early stages of oral cavity cancer. We seek to investigate whether patients with such high-risk features stand to gain benefit by receiving post-operative radiation therapy (PORT) in an effort to lower the risk of local recurrence, and potentially to improve overall survival. We also seek to learn more about patterns of spread, such as whether particular pathological features increase the chance of contralateral neck nodal failure

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Treated for early-stage (cT1-2N0M0) oral cavity cancer They must have been treated with curative intent via surgery, with or without adjuvant therapies Must have had at least two years of follow-up, or death.

排除标准

  • Patients who are being treated for recurrence (either palliatively or by salvage surgery) or for distant metastasis at presentation.

结局指标

主要结局

Overall Survival between radiation and no radiation groups.

时间窗: 3 year, 5 year

Overall Survival between radiation and no radiation groups in patients with WPOI V

时间窗: 3 year, 5 year

次要结局

  • Recurrence rates between radiation & no radiation groups.(Patterns of recurrence)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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