Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.
详细描述
The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.
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
- Single (Participant)
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 (according to World Health Organization (WHO 2005) histologically type).
- •A Karnofsky performance status of at least 80;
- •Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N
- •Adequate marrow: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/l.
- •Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- •Adequate renal function: a creatinine clearance rate of at least 60 mL/min.
- •Patients must be informed of the investigational nature of this study and give written informed consent.
排除标准
- •WHO Type keratinizing squamous cell carcinoma.
- •Age >65 years or <18 years.
- •Distant metastasis,
- •Treatment with palliative intent.
- •Pregnancy or lactation.
- •a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy.
- •history of renal disease, unstable cardiac disease requiring treatment.
研究组 & 干预措施
IInductive chemotherapy + concurrent cisplatin and IMRT
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy.
干预措施: Inductive chemotherapy + concurrent cisplatin and IMRT (Drug)
Inductive chemotherapy + IMRT
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
干预措施: Inductive chemotherapy + IMRT (Drug)
结局指标
主要结局
Overall survival
时间窗: 3-year
Overall survival is calculated from randomization to death from any cause.
Failure-free survival
时间窗: 3-year
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
Locoregional failure-free survival
时间窗: 3-year
the latency to the first local failure
Distant failure-free survival
时间窗: 3-year
The latency to the first remote failure
次要结局
- Difference in the complete response rates between the two treatment arms(12 weeks after the completion of therapy)
研究者
Jian-jun Li
Dr
Sun Yat-sen University