A Multicenter, Prospective, Randomized, Phase II Trial Evaluating Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Progression-free survival
研究概览
简要总结
Radiotherapy is an important treatment for initial distant metastases nasopharyngeal carcinoma. Total dose and fraction size are important prognostic factors for survival, although to our knowledge the optimal model has not been well determined to date. The purpose of this clinical trial is to investigate the optimal radiation dose to investigate the feasibility of decreasing the total dose and increasing the fraction size with the objective of achieving a better balance between local control and severe late complications. for initial distant metastases nasopharyngeal carcinoma with definitive radiotherapy.
详细描述
PRIMARY OBJECTIVES:
I. To determine if hypofractionated with a smaller total dose radiation is not inferior to standard-dose radiation in progression-free survival for initial distant metastases nasopharyngeal carcinoma .
SECONDARY OBJECTIVES:
I. To evaluate if hypofractionated with a low total dose radiation is not inferior to standard-dose radiation in overall survival and locoregional failure-free survival for initial distant metastases nasopharyngeal carcinoma II. To evaluate if hypofractionated with a low total dose radiation with chemotherapy decrease treatment-related toxicities
OUTLINE:
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
- Single (Participant)
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
- •Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type) Tumor staged as any T or any N with M (according to the 8th AJCC edition).
- •No pregnant female
- •Age between 18-70
- •Normal complete blood count level (hemoglobin >10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL)
- •Normal hepatic functions (serum total bilirubin ≤1.6 mg/dL, serum transminase < 2.5 times higher than upper limit)
- •Normal renal function (serum creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min)
- •Karnofsky performance status (KPS) score of at least 70
- •Without radiotherapy or chemotherapy
- •Patients must give signed informed consent
排除标准
- •Other or mixed pathological type
- •age > 70 years or <18 years
- •Prior chemotherapy, radiation, surgical resection or target therapy of the primary tumor;
- •Significant medical or psychiatric illnesses that in the physician's judgment (uncontrolled coronary heart disease, cardiomyopathy and/or heart failure requiring hospitalization. Uncontrolled hypertension or history of myocardial infarction within one year. Uncontrolled diabetes mellitus. Acute bacterial or fungal infection requiring intravenous antibiotics;
- •Refused to sign informed consent form
- •Concurrent pregnancy or lactation
- •History of a second malignancy other than nasopharyngeal carcinoma
结局指标
主要结局
Progression-free survival
时间窗: 2 years
The time from the first day of therapy to locoregional relapse, distant relapse or tumor-related death
次要结局
- Overall survival(2 years)
- Locoregional relapse-free survival(2 years)
- Distant metastasis-free survival(2 years)
研究者
Wei Jiang
Wei Jiang, MD, PhD
Guilin Medical University, China