A Multicenter Trial Comparing Neoadjuvant Chemotherapy Followed by CCRT v.s. CCRT Alone in Locoregionally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- distant metastasis free survival,disease free survival
研究概览
简要总结
Locoregionally advanced nasopharyngeal carcinoma (NPC)(stage III, IV in UICC 2002 Classification) can be divided into two groups according to the risk of metastasis: high-risk metastasis group (T4 or N2-3) and low-risk metastasis group (T3N0-1). In low-risk metastasis group, concurrent chemoradiotherapy (CCRT) might decrease local recurrence and distance metastasis, which benefits overall survival. On the other hand, neoadjuvant chemotherapy is also associated with lower distance metastasis of advanced stage NPC. Nevertheless, CCRT alone or neoadjuvant chemotherapy alone leads to unsatisfactory results regarding to distance metastasis in patients with high-risk metastasis group. In this case, it is utmost important to investigate the new treatment combining neoadjuvant chemotherapy plus CCRT in order to improve overall survival of locoregionally advanced NPC with high-risk metastasis.
In our study, in order to investigate the effect and adverse reaction of neoadjuvant chemotherapy plus CCRT on distance metastasis and locoregionally relapse, four hundred patients with high risk of distance metastasis will be randomly divided into two groups, comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of distance metastasis.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO II or III
- •Original clinical stage must be T4 or N2-3 （UICC 2002）
- •Male and no pregnant female
- •Age between 18-60
- •WBC ≥4,000/mm3 and PLT ≥ 100,000/mm3
- •With normal liver function test (ALT、AST≤2.5×ULN)
- •With normal renal function test (Creatinine ≤ 1.5×ULN)
- •Performance status scale ECOG grade 0，1
- •Without radiotherapy or chemotherapy
- •Patients must give signed informed consent
排除标准
- •Patients have evidence of relapse or distant metastasis
- •The presence of uncontrolled life-threatening illness
- •Receiving other ways of anti-cancer therapy
- •Receiving radiotherapy or chemotherapy
- •Investigator consider the patients can't finish the whole study
研究组 & 干预措施
B
Drug: cisplatin. Patients in the control arm received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.
干预措施: neoadjuvant chemotherapy plus concurrent chemoradiotherapy (Drug)
结局指标
主要结局
distant metastasis free survival,disease free survival
时间窗: 5-Yr
次要结局
- overall survival(5-Yr)
研究者
Hong Ming-huang
the director of GCP
Sun Yat-sen University