A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 4
- 主要终点
- The primary endpoint is the disease-free survival.
研究概览
简要总结
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.
详细描述
Rationale of induction chemotherapy:
Distant metastasis is the major cause of treatment failure and deaths in patients with loco-regionally advanced NPC.
Concurrent chemoradiotherapy may prolong survivals for patients with advanced NPC, but it is still flawed by high incidence of distant metastasis.
Induction chemotherapy with MEPFL has been shown to reduce the incidence of distant metastasis in a Phase II study.
Induction chemotherapy plus concurrent chemoradiotherapy may improve the survival of patients with advanced NPC.
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
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proved nasopharyngeal carcinoma.
- •T4NxM0 or TxN3M0 disease by UICC/AJCC 1997 staging system. (30)
- •Eastern Cooperative Oncology Group performance status <
- •A leukocyte count ≥3750/mL, Hb ≥ 10 g/dL, and a platelet count ≥100,000/mL.
- •A serum bilirubin level < 1.5 mg/dL, serum creatinine level < 1.6 mg/dL or creatinine clearance > 60 mL/min.
- •Age less than 70 years old
- •An informed consent signed.
排除标准
- •Evidence of metastatic disease.
- •Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin.
- •Presence of uncontrolled hypertension, poorly controlled heart failure.
- •Presence of active infection.
- •Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies.
- •Women who test positive for pregnancy.
研究组 & 干预措施
A arm
CCRT
干预措施: CCRT (Radiation)
B arm
Induction/CCRT
干预措施: CCRT (Radiation)
B arm
Induction/CCRT
干预措施: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin (Drug)
结局指标
主要结局
The primary endpoint is the disease-free survival.
时间窗: 10 years
follow up for 2 years after off study treatment
次要结局
- Secondary endpoints include overall survival and tumor response rate.(10 years)