Cetuximab/Paclitaxel/Cisplatin Concurrent Chemoradiotherapy Followed by Esophagectomy for Loco-regional Esophageal Cancer
A Phase II Study of Combining Cetuximab Plus Twice Weekly Paclitaxel/Cisplatin Concurrent Chemoradiotherapy (TP-CCRT) Followed With or Without Esophagectomy for Loco-regional Esophageal Squamous Cell Carcinoma (ESCC)
研究概览
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
-
-
-
Taipei、台湾、10002
- 招聘中
- National Taiwan University Hospital
-
接触：
- Chih-Hung Hsu, M.D., Ph.D.
- 电话号码：67680 886-2-23123456
- 邮箱：chihhunghsu@ntu.edu.tw
-
首席研究员：
- Chih-Hung Hsu, M.D., Ph.D.
-
-
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:
- Pathologically proven squamous cell carcinoma of esophagus.
Loco-regional diseases, which are defined by TNM system of American Joint Committee on Cancer (AJCC) Cancer Staging System (6th edition) in 2002, fulfilling one of the following criteria:
A. T3, N0, M0; B. T1-3, N1, M0; C. T1-3 or N0-1, M1a will be eligible provided the lesions could be covered by appropriate radiation fields.
- Age ≥ 18 years old.
- Performance status ECOG 0~2.
Adequate bone marrow reserves, defined as:
A. white blood cells (WBC) ≥ 4,000/µl or neutrophil count (ANC) ≥ 2,000/µl; B. platelets ≥ 100,000/µl.
Adequate liver function reserves, defined as:
A. hepatic transaminases ≤ 2.5 x upper limit of normal (ULN); B. serum total bilirubin ≤ 1.5 x upper limit of normal (ULN).
- Adequate renal function: Creatinine ≤1.5 mg/dl
- Written informed consent.
Exclusion Criteria:
- Invasion to surrounding organ (T4 disease).
- Distant metastasis, except M1a disease listed in the inclusion criteria 2-C.
- Adenocarcinoma of gastroesophageal (GE) junction.
- Prior thoracic irradiation.
- Synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer.
Prior malignancy, except for the following:
A. adequately treated basal cell or squamous cell skin cancer; B. in-situ cervical cancer; C. Note: previously treated aerodigestive squamous cell carcinoma is not allowed.
- Significant co-morbid disease, which prohibit the conduction of chemotherapy, concurrent chemoradiotherapy, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.
- Estimated life expectancy less than 3 months.
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：Targeted therapy
Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy
|
Cetuximab: loading dose 400 mg/m2, 2h- IVF, 3~ 5 days prior to starting CCRT (on week-1); followed by 250 mg/m2/ week, 1h- IVF, for 4 weeks (i.e., week 1 to week 4. during CCRT).
其他名称：
T: Paclitaxel 35 mg/m2, 1h IVF, on day 1 and day 4 of each week, week1 to week4 during CCRT.
P: Cisplatin 15 mg/m2, 1 h IVF, on day 2 and day 5 of each week, week1 to week4 during CCRT.
Radiotherapy: (three-dimensional conformal radiotherapy or intensity modulated radiotherapy) 200 cGy/fraction, once daily, 5 days a week, to a total dose of 4000 cGy.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To determine the clinical response rate in patients with loco-regional esophageal squamous cell carcinoma treated with cetuximab combined with twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy (C-TP-CCRT, 40 Gy).
大体时间：2 years
|
2 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Pathologic complete response (pCR).
大体时间：2 years
|
2 years
|
|
Disease-free survival.
大体时间：2 years
|
2 years
|
|
Safety and toxicity of cetuximab combined with twice weekly TP-CCRT, followed by surgery.
大体时间：2 years
|
2 years
|
合作者和调查者
调查人员
- 首席研究员：Yung-Chie Lee, M.D.、National Taiwan University Hospital
出版物和有用的链接
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Cetuximab的临床试验
-
Pfizer招聘中实体瘤美国, 西班牙, 加拿大, 意大利, 澳大利亚, 匈牙利, 荷兰, 英国, 德国, 巴西, 大韩民国, 葡萄牙, 法国, 日本, 以色列, 斯洛伐克, 捷克语