Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and concurrent chemoradiation.
Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen.
The third objective of this study is to evaluate who may benifit from this treatment regimen.
详细描述
Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. In the present clinical study, we hope to assess the tolerance and survival benefits of induction chemotherapy followed by concurrent chemoradiation in patients with stage III, IVa and IVb NPC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.
- •Stage Ⅲ, IVa and IVb disease
- •Age between 18-70
- •Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). Bilirubin < 1.5 mg/dl, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min.
- •the primary tumor or involved lymph node must be more than 2CM in diameter.
- •No prior radiation treatment to the head and neck or any prior chemotherapy
- •Patients with no prior malignancy (not include basal cell carcinoma of skin)
排除标准
- •Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
- •Prior radiotherapy to the head and neck region for any reason.
- •Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
- •Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
- •Pregnant women
研究组 & 干预措施
1
All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2.
干预措施: docetaxel, cisplatin, fluorouracil (Drug)
1
All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2.
干预措施: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy) (Radiation)
结局指标
主要结局
overall survival
时间窗: 3 and 5 years
次要结局
- distant metastases free survival , and disease-free survival(3 and 5 years)