Evaluating the Rationality of the International Guideline's Recommendations Regarding Selective Coverage of Level Ib in Node Clinical Target Volume With Nasopharyngeal Carcinoma : Results From a Real-world Series
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- regional recurrence-free survival (RRFS)
研究概览
简要总结
The purpose of this study was to evaluate its rationality in real-world data and provide clinical evidence for the refinement of nodal CTV delineation in nasopharyngeal carcinoma(NPC).
详细描述
Intensity-modulated radiation therapy (IMRT) has gradually replaced two-dimensional radiation therapy as it offers improved target conformity. Xerostomia is still the most common side effect of radiotherapy in patients with NPC treated with IMRT. Most stimulated saliva is secreted by the parotid glands (PGs), while the submandibular glands (SMGs) produce most of the unstimulated saliva and mucins, which may influence the degree of a dry mouth sensation.There are still differences in the understanding of nasopharyngeal cancer experts at home and abroad on the delineation of clinical target volumes., suitable criteria for elective irradiation of neck level Ib need to be re-evaluated.Therefore, we conducted a retrospective study to assess the feasibility of recommendation to level Ib in the International Guideline for Delineation of Clinical Target Volumes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed NPC by biopsy (clearly recorded in the pathology report or medical history) ;
- •no evidence of distant metastasis at initial diagnosis and receiving radical IMRT in our center
- •the following conditions: ① level IB metastasis, ② involvement of the submandibular gland, ③ involvement of structures that drain to level Ib as the first echelon site ( the oral cavity, anterior half of nasal cavity involvement) ④ involvement of level II LNs with extracapsular extension（because the judgment of extracapsular invasion is greatly influenced by subjective factors, this study only include patients who had high grade ENE(G2/G3 as demonstrated in our previous study: Oral Oncol. 2019 Dec;99:104438.)⑤ level II nodal involvement with maximum nodal axial diameter greater than 2 cm.
- •all patients who were treated at Lin Shaojun's attending group from June 2005 to December
- •presence of complete baseline magnetic resonance imaging data of the nasopharyngeal skull base and neck and treated in our center at initial diagnosis .
排除标准
- •disease progression during IMRT;
- •fail to obtain tumor efficacy evaluation information in the medical records of the research center;
- •previous malignancy or other concomitant malignant disease;
- •receiving blind treatment in clinical research.
结局指标
主要结局
regional recurrence-free survival (RRFS)
时间窗: 60 months
The duration of time to regional failure were calculated from the start of treatment to the dates of recurrence.
level IB nodal recurrence-free survival
时间窗: 60 months
The duration of time to level Ib recurrence were calculated from the start of treatment to the date of Ievel Ib recurrence.
次要结局
- local recurrence-free survival (LRFS)(60 months)
- distant metastasis-free survival (DMFS)(60 months)
- Overall survival(60 months)