Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- LRRFS
研究概览
简要总结
To analyze the long-term results and toxicities of the reducing clinical target volume (CTV) delineation method in early-stage nasopharyngeal carcinoma (NPC) patients treated with intensity modulated radiation therapy (IMRT).
详细描述
The investigators designed a prospective phase II study for early-stage NPC patients, and proposed a reasonable delineation method of reducing CTV according to the clinical characteristics and tumor infiltration patterns, performing therapeutic dose to tumor and prophylactic dose to CTV while protecting as much normal tissues as possible, in order to ensure a long-term survival with good quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •histologically confirmed NPC (WHO II-III)
- •stage I-IIb according to the 6th AJCC/UICC
- •no previous treatment for NPC
- •between 18 and 70 years old
- •KPS ≥ 80 scores
- •adequate organ function (white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥ 1.5×109/L; hemoglobin ≥ 100g/L; platelet count ≥ 100×109/L; total bilirubin, aspartate aminotransferase and alanine aminotransferase ≤ 1.5X upper limit normal; and creatinine clearance rate ≥ 30 mL/min)
排除标准
- •fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior IMRT
- •disease progression during IMRT
- •presence of distant metastasis
- •pregnancy or lactation
- •previous malignancy or other concomitant malignant disease
研究组 & 干预措施
reducing CTV
The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC. The prescribe doses of GTVnx, GTVnd, CTV1 and CTV2 were 68Gy, 60-66Gy, 60Gy and 50-54Gy in 30 fractions, respectively.
干预措施: Reducing CTV (Radiation)
结局指标
主要结局
LRRFS
时间窗: 5 year
locoregional recurrence free survival
次要结局
- DMFS(5 year)
- DSS(5 year)
- OS(5 year)
- Acute toxicity assessed with National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)(3 months after IMRT)
- Late toxicity assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria(5 year)
- Locoregional failure patterns(5 year)
研究者
Zhao Chong
Clinical Professor
Sun Yat-sen University