Phase III Randomized Non-inferiority Trial of Reduced-dose Versus Standard Dose Radiotherapy for Stage II-III Nasopharyngeal Carcinoma Which Have Favorable Response After Induction Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 452
- 试验地点
- 1
- 主要终点
- PFS (progression-free survival)
研究概览
简要总结
To study the 2-year PFS (progression-free survival) of patients with stage II-III nasopharyngeal carcinoma treated with induction chemotherapy followed by two different doses of intensity modulated radiation therapy plus concurrent cisplatin chemotherapy
详细描述
To explore the 2 year PFS of patients with stageII-III nasopharyngeal carcinoma treated with induction chemotherapy followed by reduced-dose radiotherapy and cisplatin versus standard dose radiotherapy plus cisplatin concurrent chemotherapy. The enrolled patients will receive 2 cycles of cisplatin-based induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be randomised assigned to received 60 Gy IMRT combined with 2 cycles of cisplatin concurrent chemotherapy or 70Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.
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
- •Patients newly diagnosed with histologically confirmed non-keratinizing NPC (WHO type II or III).
- •Stage II-III（8thAJCC/UICC staging system)
- •Aged 18-70 years
- •HGB≥90 g/L，WBC≥4×109 /L，PLT≥100×109 /L
- •ALT,AST<1.5 x ULN；TBIL<1.5×ULN
- •CCR≥60ml/min or Cr<1.5×ULN
- •CR/PR and EBVDNA undetectable after induction chemotherapy
- •Signed informed consent
排除标准
- •WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma
- •Age <18 or >70years
- •Treatment with palliative intent
- •Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
- •Pregnancy or lactation
- •History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume)
- •Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance
研究组 & 干预措施
Reduced-dose group
After 2 cycles of induction chemotherapy, patients with favorable response undergo low-dose (60Gy) intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive concurrent cisplatin once every three weeks for 2 cycles.
干预措施: IMRT (Radiation)
Reduced-dose group
After 2 cycles of induction chemotherapy, patients with favorable response undergo low-dose (60Gy) intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive concurrent cisplatin once every three weeks for 2 cycles.
干预措施: induction chemotherapy (Drug)
Reduced-dose group
After 2 cycles of induction chemotherapy, patients with favorable response undergo low-dose (60Gy) intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive concurrent cisplatin once every three weeks for 2 cycles.
干预措施: cisplatin concurrent chemotherapy (Drug)
Standard dose group
After 2 cycles of induction chemotherapy, patients with favorable response undergo standard-dose (70Gy) intensity modulated radiotherapy (IMRT) 5 days per week for approximately 7 weeks (33 fractions). Patients also receive concurrent cisplatin once every three weeks for 3 cycles.
干预措施: IMRT (Radiation)
Standard dose group
After 2 cycles of induction chemotherapy, patients with favorable response undergo standard-dose (70Gy) intensity modulated radiotherapy (IMRT) 5 days per week for approximately 7 weeks (33 fractions). Patients also receive concurrent cisplatin once every three weeks for 3 cycles.
干预措施: induction chemotherapy (Drug)
Standard dose group
After 2 cycles of induction chemotherapy, patients with favorable response undergo standard-dose (70Gy) intensity modulated radiotherapy (IMRT) 5 days per week for approximately 7 weeks (33 fractions). Patients also receive concurrent cisplatin once every three weeks for 3 cycles.
干预措施: cisplatin concurrent chemotherapy (Drug)
结局指标
主要结局
PFS (progression-free survival)
时间窗: 2 year
Defined as the time from randomization to documented disease recurrence (either distant metastasis or locoregional disease recurrence) or death from any cause, whichever occurred first.
次要结局
- Overall Survival(OS)(2 year)
- Locoregional relapse-free survival(LRFS)(2 year)
- Incidence rate of adverse events (AEs)(2 year)
- Distant metastasis-free survival(DMFS)(2 year)
- Overall response rate(3 months)
- Change of QoL(1 year)
- Change of EORTC quality of life questionnaire(QLQ) Head and Neck score(1 year)
研究者
Hai-Qiang Mai,MD,PhD
Professor
Sun Yat-sen University