NCT07376603招募中不适用
Intensity-Modulated Radiotherapy Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
Qiaojuan Guo1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2026年1月12日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Relapse-Free Survival
研究概览
简要总结
This observational study aims to evaluate the efficacy and safety of intensity-modulated radiotherapy (IMRT) alone in patients with stage IB nasopharyngeal carcinoma (NPC) without high-risk features. The primary objective is to determine the therapeutic effectiveness of this approach
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •1. Histopathologically confirmed, newly diagnosed nasopharyngeal carcinoma
- •Age 18-70 years
- •Stage IB disease (T1-2N1M0) per the 9th edition AJCC/UICC staging system
- •Upper-neck nodal metastasis only: inferior border of every positive node at or above the inferior border of the hyoid bone
- •ECOG performance status 0-2
- •Adequate bone-marrow function
排除标准
- •Age > 70 years or < 18 years
- •Matted lymph nodes: two or more contiguous nodes with loss of intervening fat planes and/or extracapsular extension forming a confluent mass
- •Largest metastatic lymph-node ≥ 3 cm in the longest dimension
- •Lower-neck nodal metastasis: inferior border of any positive node below the inferior border of the hyoid bone
- •Prior malignancy except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
- •Pregnancy or lactation (serum pregnancy test required for women of child-bearing potential; effective contraception mandatory during treatment)
- •Previous radiotherapy to the head-and-neck region
- •Prior chemotherapy or surgery for the primary tumour or metastatic nodes (diagnostic procedures excluded)
- •Any severe comorbidity that would confer unacceptable risk or compromise protocol adherence, including but not limited to unstable cardiac disease, renal failure, chronic hepatitis, or uncontrolled psychiatric disorder
- •History of severe hypersensitivity reactions
研究组 & 干预措施
IMRT along
IMRT Alone for 169 Patients with Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
干预措施: IMRT along (Radiation)
结局指标
主要结局
Relapse-Free Survival
时间窗: 3-year
Time from diagnosis to the disease relapse (either locoregional recurrence or distant metastasis) or death from any cause.
次要结局
- Locoregional Relapse-Free Survival(3-year)
- Distant Metastasis-Free Survival(3-year)
- Overall Survival(3-year)
- Safety of Radiation(at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months)
- Quality of life (EORTC QLQ C30)(at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.)
- Quality of life score QLQ-HN35(at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.)
研究者
Qiaojuan Guo
Professor
Fujian Cancer Hospital
研究点 (1)
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