NCT06752239招募中3 期
Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in Nasopharyngeal Carcinoma (PROTECT-NPC): A Multicenter, Non-Inferiority, Open-Label, Randomized Controlled Phase III Clinical Trial
Jiangxi Provincial Cancer Hospital1 个研究点 分布在 1 个国家目标入组 474 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 474
- 试验地点
- 1
- 主要终点
- Regional Recurrence-free Survival
研究概览
简要总结
This study is a multicenter, non-inferiority, open-label, randomized controlled Phase III clinical trial. It aims to compare the efficacy of modified delineation radiotherapy (experimental group) versus standard delineation radiotherapy (control group) in the prophylactic irradiation of neck lymphatic drainage areas III/IVa in nasopharyngeal carcinoma. The study evaluates the incidence of primary hypothyroidism, quality of life, and adverse events between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female, aged 18-70 years;
- •Pathologically confirmed nasopharyngeal carcinoma;
- •No positive lymph nodes in unilateral or bilateral regions III and IVa;
- •Clinical stage I-IVa (AJCC/UICC 8th edition), with no evidence of distant metastasis;
- •Normal thyroid function;
- •ECOG performance status of 0-1;
- •Treatment-naïve patients who have not received any prior antitumor therapy;
- •No contraindications to radiotherapy or chemotherapy;
- •Adequate organ function, meeting the following criteria: Hematologic criteria: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L (no transfusion, blood products, or hematopoietic growth factors used within the past 7 days); Biochemical criteria: ALT and AST < 1.5 × ULN, ALP < 2.5 × ULN, total bilirubin < ULN, BUN and creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
- •Voluntarily agreed to participate in the study, signed the informed consent form, demonstrated good compliance, and agreed to follow-up.
排除标准
- •History of other malignant tumors (excluding basal cell carcinoma/squamous cell carcinoma of the skin or cervical carcinoma in situ);
- •History of radiotherapy (excluding radiotherapy outside the planned target area for conditions such as melanoma);
- •History of neck surgery;
- •Any severe comorbidities that may pose risks to the study or affect compliance, such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5 × ULN), or psychiatric disorders;
- •History of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders;
- •Other family or social factors, as judged by the investigator, may force the study's early termination, compromise patient safety, or affect the collection of trial data.
结局指标
主要结局
Regional Recurrence-free Survival
时间窗: 3 years
Regional Recurrence-Free Survival (RRFS) is defined as the time interval from the date of randomization to the date of lymph node failure in the cervical lymphatic drainage area or the last follow-up date.
次要结局
- Overall Survival(3 years)
- Disease-free Survival(3 years)
- Hypothyroidism-Free Survival(3 years)
- Clinical Hypothyroidism-Free Survival(3 years)
- Global Health Status(1year, 2 year and 3 years)
研究者
Jingao Li
PI
Jiangxi Provincial Cancer Hospital
研究点 (1)
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