Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC) (TPF for NPC)
Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
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.
研究概览
地位
条件
详细说明
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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-
Shanghai
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Shanghai、Shanghai、中国、200032
- Department of Radiation Oncology, Cancer Hospital, Fudan University
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.
- Stage Ⅲ, IVa and IVb disease
- KPS >70
- 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)
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的: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.
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新辅助化疗:第1天多西紫杉醇75 mg/m2;第 1 天顺铂 75 mg/m2;第 1 天至第 5 天以 500 mg/m2/d 的剂量连续输注氟尿嘧啶。 同步化疗:顺铂 40 mg/m2 每周一次 |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
总生存期
大体时间:3 和 5 年
|
3 和 5 年
|
次要结果测量
结果测量 |
大体时间 |
---|---|
无远处转移生存和无病生存
大体时间:3 和 5 年
|
3 和 5 年
|
合作者和调查者
调查人员
- 首席研究员:XiaoShen WANG, M.D.、Department of Radiation Oncology, Cancer Hospital, Fudan University
- 学习椅:ChaoSu HU, M.D.、Department of Radiation Oncology, Cancer Hospital, Fudan University
- 首席研究员:ChunYing Shen, M.D.、Department of Radiation Oncology, Cancer Hospital, Fudan University
- 首席研究员:HongMei Ying, M.D.、Department of Radiation Oncology, Cancer Hospital, Fudan University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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