Cisplatin and 5-fluorouracil(PF) or Docetaxel,Cisplatin and 5-fluorouracil (TPF) Neoadjuvant Chemotherapy With Chemoradiation Therapy for Locally Advanced Nasopharyngeal Carcinoma--A Randomised Prospective Multicenter Phase 3 Study
试验速览
- 阶段
- 3 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 3-year progress free survival(PFS)
研究概览
简要总结
Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.
详细描述
For locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb),the investigators randomised assign to either 3 cycles of cisplatin plus 5-fluorouracil plus (PF) or 3 cycles of docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy. 21 days a cycle.
After the neoadjuvant chemotherapy ,the patients will receive the intensity modulated radiotherapy(IMRT) with 2 cycles of concurrent chemotherapy of cisplatin 80mg/m2.
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 with newly histologically confirmed non-keratinizing carcinoma.
- •Tumor staged as N2-3 or T3-4N1(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 controled blood glucose for diabetes patients
- •Written informed consent
排除标准
- •WHO type I squamous cell carcinoma or adenocarcinoma
- •Age>70 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 skin0
- •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
PF group
the group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy
干预措施: PF (cisplatin and 5-fluorouracil) group (Drug)
TPF group
TPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy
干预措施: TPF (docetaxel plus cisplatin and 5-fluorouracil) group (Drug)
结局指标
主要结局
3-year 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 using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups.
次要结局
- overall survival(OS)(2 years ,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)
- local control rate (LCR)(1 year ,2 years,3 years and 5 years after the inception of the study)