Cetuximab in Combination With Radiation Therapy and Chemotherapy Prior to Surgery in Patients With Resectable, Locally Advanced Esophageal Carcinoma. A Multicenter Phase IB-II Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab, docetaxel, and cisplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I/II trial is studying the side effects of cetuximab, docetaxel, cisplatin, and radiation therapy and to see how well they work in treating patients with locally advanced esophageal cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin in patients with resectable locally advanced esophageal cancer.
Secondary
- Determine the feasibility and efficacy of this regimen in these patients.
- Determine the duration of response and patterns of failure in patients treated with this regimen.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus
- •Carcinoma of the gastroesophageal junction (i.e., Siewert staging system type I disease) allowed
- •Locally advanced disease
- •Obstructive tumors are considered locally advanced disease
- •Meets 1 of the following staging criteria:
- •T3, N0 disease
- •T1-3, N1 disease
- •T4, N0-1 disease
- •Resectable disease
- •No T4 (unequivocal organ involvement) disease that cannot be resected with curative intent
- •No airway infiltration in case of tumors of the upper third of the thoracic esophagus
- •No cervical esophageal carcinoma
- •No distant metastasis, including stage M1a (celiac node involvement) by fine-needle aspiration or biopsy
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Creatinine clearance > 60 mL/min
- •Bilirubin normal
- •Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
- •AST ≤ 1.5 times ULN
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- •No other malignancy within the past 5 years except nonmelanomatous skin cancer or adequately treated in situ cervical cancer
- •No severe or uncontrolled cardiovascular disease including, but not limited to, any of the following:
- •New York Heart Association class III or IV congestive heart failure
- •Unstable angina pectoris
- •Myocardial infarction within the past 3 months
- •Significant arrhythmias
- •No psychiatric disorder that would preclude study compliance
- •No active uncontrolled infection
- •No serious underlying medical condition that, in the opinion of the investigator, would interfere with study participation (e.g., uncontrolled diabetes mellitus or active autoimmune disease)
- •No peripheral neuropathy > grade 1
- •No contraindications to corticosteroids
- •No known hypersensitivity to any component of the study drugs
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy
- •No prior radiotherapy to the chest
- •No participation in another clinical trial within the past 30 days
- •No other concurrent experimental drugs or anticancer therapy
- •No concurrent drugs contraindicated for use with the study drugs
排除标准
- 未提供
结局指标
主要结局
Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin
时间窗: Until treatment ends
Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin
次要结局
- Determine the feasibility and efficacy of the study's regimen(Until trial ends)
- Determine the duration of response and patterns of failure(Until trial ends)