A Multicenter and Prospective Clinical Trial of Gemcitabine-based Induction Chemotherapy Combined With Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Maximum tolerance dose(MTD)
研究概览
简要总结
Researchers conduct the clinical trial (gemcitabine combined with cisplatin induction chemotherapy followed by concurrent chemoradiotherapy with gemcitabine for locally advanced nasopharyngeal carcinoma) to evaluate the safety and effectiveness of gemcitabine in patients with locally advanced nasopharyngeal carcinoma.
详细描述
Diagnosed as locally advanced nasopharyngeal carcinoma (stage III-IV), and pathologically confirmed as a differentiated or undifferentiated non-keratinizing nasopharyngeal carcinoma, the patient is eligible to participate in the study. Patients receive gemcitabine (1000mg/m² d1,8) and cisplatin (80mg/m², d1) every 3 weeks for 2 cycles before radiotherapy. And then intensity modulated radiotherapy (IMRT) is given a total dose of GTVnx 70Gy, GTVnd 66Gy, CTV1 60Gy and CTV2 54Gy for 33 times in total, concurrently with gemcitabine. The initial dose of gemcitabine is 25mg/m² once a week for 6 times. The patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group. Considering about 20% of the cases of dropout, withdrawal, and loss to follow-up in clinical trials, a total of 65 cases are needed in this study. The efficacy is evaluated according to the European Solid Tumor Efficacy Evaluation Standard (RECIST1.1). After induction chemotherapy, radiotherapy, and 3 months after radiotherapy, nasopharyngeal endoscopy and magnetic resonance imaging of the would be reviewed for 1 year, 2 years, and 3 years to evaluate the curative effect. The chest CT, abdominal B-ultrasound, bone scan or PETCT examinations are reviewed to exclud distant metastases. Biopsy diagnosis can be performed for patients suspected of local residual and recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 non-keratinizing carcinoma (according to WHO histological type)
- •Tumor staged as Ⅲ-Ⅳa (according to the 8th AJCC edition staging system)
- •Age :18-60
- •Performance status: KPS > 70
- •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
- •Renal: creatinine clearance > 60ml/min
- •Adequate marrow: leucocyte count > 4×109/L, neutrophil count > 2×109/L, and platelet count > 100×109/L
- •Written informed consent
排除标准
- •History of allergy to related drugs
- •Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
- •History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume)
- •Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance
研究组 & 干预措施
Induction chemotherapy + IMRT and concurrent gemcitabine
Patients receive gemcitabine (1000mg/m² d1,8) and cisplatin (80mg/m²,d1) every 3weeks for 2 cycles before radiotherapy, and then receive intensity modulated radiotherapy (IMRT) concurrently with gemcitabine. The initial dose of gemcitabine is 25mg/m² once a week for 6 times. Patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group.
干预措施: Gemcitabine combined with cisplatin induction chemotherapy (Drug)
Induction chemotherapy + IMRT and concurrent gemcitabine
Patients receive gemcitabine (1000mg/m² d1,8) and cisplatin (80mg/m²,d1) every 3weeks for 2 cycles before radiotherapy, and then receive intensity modulated radiotherapy (IMRT) concurrently with gemcitabine. The initial dose of gemcitabine is 25mg/m² once a week for 6 times. Patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group.
干预措施: concurrent chemoradiotherapy with gemcitabine (Drug)
结局指标
主要结局
Maximum tolerance dose(MTD)
时间窗: 3 years
MTD is detemined by the dose that is immediately lower than the dose that produced dose limiting toxicity （DLT）. If DLT occurs in more than half of patients at a certain dose level, the test will be terminated. If DLT occurs in 2 cases,another 6 patients will be treated with this dose. If DLT does not occur in 6 cases, the dose will continue to increase. If it still occurs, the next dose is MTD.
次要结局
- Dose limiting toxicity (DLT)(3 years)
- Tumor response rates(3 years)
研究者
Qi Zeng
Principal Investigator
Fifth Affiliated Hospital, Sun Yat-Sen University