A Multicenter Randomized Controlled Trial Comparing Reduced Dose With Regular Dose Intensity-modulated Radiotherapy for Chemotherapy Sensitive Stage II-III Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 508
- 试验地点
- 7
- 主要终点
- Progress-free survival (PFS)
研究概览
简要总结
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that radiotherapy with reduced dose could significantly reduce the incidence of radiotherapy toxicities, improve the quality of life of patients while ensuring the tumor control rates for NPC patients staged as II-III who are sensitive to induction chemotherapy (imaging evaluation of CR/PR and EBV DNA copy number decreased to 0 copies/mL after induction chemotherapy)
详细描述
Through multicenter, open-label, randomised clinical trials, patients with NPC staged as II-III with CR/PR according to RECIST criteria and EBV DNA decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy will be randomized into experimental group to receive IMRT of reduced dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions) and control group to receive IMRT of conventional dose (prescribed dose, 69.96 Gy, 2.13 Gy per time, 33 fractions). Two cycles of cisplatin chemotherapy will be performed during IMRT. The efficacy, toxicity, and quality of life of patients between the two groups will be compared.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- •Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) at diagnosis (according to the 8th AJCC edition).
- •Aged between 18-70 years.
- •Karnofsky scale (KPS)≥
- •Normal bone marrow function.
- •Evaluated as PR or CR after 3 cycles of GP induction chemotherapy.
- •EBV DNA copy number decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy.
- •Normal liver and kidney function:
- •total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
- •creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
- •Given written informed consent.
排除标准
- •Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
- •Recurrent or metastatic nasopharyngeal carcinoma.
- •Evaluated as SD or PD after 3 cycles of GP induction chemotherapy.
- •EBV DNA copy number of more than 0 copies/mL after 3 cycles of GP induction chemotherapy.
- •Pregnancy or lactation (Pregnancy tests should be considered for women in childbearing age, and effective contraception should be emphasized during treatment.)
- •Other invasive malignant diseases in the past, other than cured basal cell skin carcinoma, squamous cell carcinoma, cervical carcinoma in situ.
- •Primary and regional lesions have been treated with chemotherapy or surgery (except diagnostic purpose)
- •Any severe disease, which may cause unacceptable risk factors or affect compliance with the trial, for example, unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5×ULN), and mental illness.
结局指标
主要结局
Progress-free survival (PFS)
时间窗: 3 years
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
次要结局
- Distant Metastasis-Free Survival (DMFS)(3 years)
- Locoregional Relapse-Free Survival (LRRFS)(3 years)
- Incidence of treatment related acute complications(up to 1 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)(up to 3 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)(up to 3 years)
- Overall Survival (OS)(3 years)
- Incidence of treatment related late complications(up to 3 years)
研究者
Ming-Yuan Chen
Proffessor
Sun Yat-sen University