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)
试验速览
- 阶段
- 2 期
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
We hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy (TP-CCRT) as the adjunctive therapy before esophagectomy or as a definitive CRT would improve the therapeutic efficacy of TP-CCRT in patients with loco-regional esophageal squamous cell carcinoma (ESCC).
详细描述
We hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy as the adjunctive therapy before esophagectomy or as a definitive CRT would improve the therapeutic efficacy of TP-CCRT in patients with loco-regional esophageal squamous cell carcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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~
- •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.
排除标准
- •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.
研究组 & 干预措施
Targeted therapy
Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy
干预措施: Cetuximab (Drug)
Targeted therapy
Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy
干预措施: Paclitaxel (Drug)
Targeted therapy
Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy
干预措施: Cisplatin (Drug)
Targeted therapy
Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
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).
时间窗: 2 years
次要结局
- Safety and toxicity of cetuximab combined with twice weekly TP-CCRT, followed by surgery.(2 years)
- Disease-free survival.(2 years)
- Pathologic complete response (pCR).(2 years)