The Multicenter Randomized Phase 3 Trial of Individualized Elective Neck Irradiation Based on MRI in Patients With Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 446
- 试验地点
- 1
- 主要终点
- Regional relapse-free survival
研究概览
简要总结
Currently, most protocols of nasopharyngeal carcinoma (NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node (LN) metastasis in NPC followed an orderly manner. Retropharyngeal LNs were the most commonly involved, followed by upper neck levels II, III, or VA nodes, and finally to the lower neck nodes including level IV and VB nodes; and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck LN metastases to experience neck failure after elective irradiation to levels II, III and VA. It was also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs. Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC patients with unilateral or bilateral uninvolved neck.
详细描述
Currently, most protocols of nasopharyngeal carcinoma (NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node (LN) metastasis in NPC followed an orderly manner. Retropharyngeal LNs were the most commonly involved, followed by upper neck levels II, III, or VA nodes, and finally to the lower neck nodes including level IV and VB nodes; and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck LN metastases to experience neck failure after elective irradiation to levels II, III and VA. It was also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs. Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC patients with unilateral or bilateral uninvolved neck.
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
- 否
入选标准
- •The eligibility criteria are: newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; with unilateral or bilateral uninvolved neck; aged between 18 and 65 years; Karnofsky performance-status score > 70; adequate haematological function, with a leucocyte count > 4 × 109/L, haemoglobin > 90 g/L, and a thrombocyte count > 100×109/L.
排除标准
- •include: previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy; lactation or pregnancy; or severe coexisting illness.
结局指标
主要结局
Regional relapse-free survival
时间窗: 3 year
The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.
次要结局
- Overall survival(3 year)
- Patient's quality-of-life: fatigue(3 year)
- Patient's quality-of-life: open mouth(3 year)
- Local relapse-free survival(3 year)
- Patient's quality-of-life: appetite loss(3 year)
- Patient's quality-of-life: global health status(3 year)
- Patient's quality-of-life: physical functioning(3 year)
- Patient's quality-of-life: role functioning(3 year)
- Patient's quality-of-life: nausea and vomiting(3 year)
- Patient's quality-of-life: insomnia(3 year)
- Patient's quality-of-life: swallowing(3 year)
- Patient's quality-of-life: sticky saliva(3 year)
- Patient's quality-of-life: felt ill(3 year)
- Patient's quality-of-life: weight gain(3 year)
- Patient's quality-of-life: cognitive functioning(3 year)
- Patient's quality-of-life: constipation(3 year)
- Patient's quality-of-life: trouble social eating(3 year)
- Patient's quality-of-life: less sexuality(3 year)
- Patient's quality-of-life: teeth(3 year)
- Patient's quality-of-life: pain killers(3 year)
- Patient's quality-of-life: financial difficulties(3 year)
- Radiation-related toxicity(Within 1 month after radiotherapy for acute toxicity; long term for late toxicity)
- Distant metastasis-free survival(3 year)
- Patient's quality-of-life: emotional functioning(3 year)
- Patient's quality-of-life: social functioning(3 year)
- Patient's quality-of-life: dyspnoea(3 year)
- Patient's quality-of-life: diarrhoea(3 year)
- Patient's quality-of-life: speech problems(3 year)
- Patient's quality-of-life: weight loss(3 year)
- Patient's quality-of-life: sense problems(3 year)
- Patient's quality-of-life: trouble social contact(3 year)
- Patient's quality-of-life: dry mouth(3 year)
- Patient's quality-of-life: coughing(3 year)
- Patient's quality-of-life: nutrition supplement(3 year)
- Patient's quality-of-life: feeding tube(3 year)
- Patient's quality-of-life: pain(3 year)
研究者
Ling-Long Tang
associated professor
Sun Yat-sen University