Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Progress Free Survival (PFS)
研究概览
简要总结
In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).
详细描述
In this study, the investigators aim to compare the survival outcomes and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) with Docetaxel and Cisplatin treated using intensity-modulated radiotherapy (IMRT) or tomotherapy (TOMO).
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 65 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 carcinoma.
- •Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system)
- •No evidence of distant metastasis (M0)
- •Performance status: KPS>70
- •With normal liver function test (ALT, AST <1.5ULN)
- •Renal: creatinine clearance >60ml/min
- •Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L.
- •With controlled blood glucose for diabetes patients
- •Written informed consent
- •satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)
排除标准
- •WHO type I squamous cell carcinoma or adenocarcinoma
- •Age >65 or <18
- •With a history of renal disease
- •Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
- •Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- •Patient is pregnant or lactating
- •Peripheral neuropathy
- •Emotional disturbance
研究组 & 干预措施
IC+RT group
3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.
干预措施: Docetaxel (Drug)
IC+RT group
3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.
干预措施: Cisplatin (Drug)
IC+RT group
3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.
干预措施: IMRT/TOMO (Radiation)
IC+CCRT group
3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.
干预措施: Docetaxel (Drug)
IC+CCRT group
3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.
干预措施: Cisplatin (Drug)
IC+CCRT group
3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.
干预措施: IMRT/TOMO (Radiation)
IC+CCRT group
3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progress Free Survival (PFS)
时间窗: 3 years after the inception assignment
PFS means assignment to the date of any local or distant progress of the disease.
次要结局
- Overall Survival (OS)(3 years and 5 years after the inception of the assignment)
- Adverse Events(Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years)