Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Quality of Life Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 568
- 试验地点
- 1
- 主要终点
- Local replase-free survival rate
研究概览
简要总结
This is an randomized, controlled, phase 3 clinical trial. The purpose of this study is to evaluate whether medial group retropharyngeal node （MRLN） sparing could reduce the incidence of radiation-caused dysphagia and improve patients' quality of life without compromising survival rate.
详细描述
In this study, patients with non-keratinizing stage T1-4 N0-3 M0 NPC(UICC/AJCC 8th edition), except for patients with MRLN metastasis, are randomly assigned to receive MRLN sparing or prophylactic irradiation . Patients in MRLN sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr. Our primary endpoint is local relapse-free survival (LRFS). Secondary end points include overall survival (OS), incidence of out-field recurrence rate, toxic effects, and quality of life (QOL).All efficacy analyses are conducted in the intention-to treat population, and the safety population include only patients who receive their randomly assigned treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients without medial group retropharyngeal node metastasis;
- •Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type);
- •Tumor staged as T1-4N0-3(according to the 8th AJCC edition);
- •No evidence of distant metastasis (M0);
- •Satisfactory performance status: Karnofsky scale (KPS) ≥ 70;
- •Patients must be informed of the investigational nature of this study and give written informed consent.
排除标准
- •Patients with medial group retropharyngeal node metastasis;
- •Aged > 65 or < 18;
- •Treatment with palliative intent;
- •Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer;
- •Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period);
- •With history of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume);
- •Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes;
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
结局指标
主要结局
Local replase-free survival rate
时间窗: 3 Year
Local failure-free survival is calculated from randomization to the first local failure
次要结局
- Incidence of acute and late toxicity(1 year)
- Dysphagia related quality of life(1 year)
- Incidence of out-field recurrence rate(3 Year)
- Overall survival(3 Year)
研究者
Jun Ma, MD
Professor
Sun Yat-sen University