Neoadjuvant Radiochemotherapy in Local Advanced Squamous Cell Carcinoma of the Esophagus With Weekly Cetuximab Plus Oxaliplatin Plus Continuous IV. 5-FU and Conventional Fractionated External Multi-Field Irradiation up to 45 Gray. A Phase I/II Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 43
- 试验地点
- 6
- 主要终点
- Maximum tolerated dose of oxaliplatin and fluorouracil (Phase I)
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. Cetuximab may also make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, 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, chemotherapy, and 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 and best dose of oxaliplatin and fluorouracil when given together with cetuximab and radiation therapy and to see how well they work in treating patients with stage II or stage III esophageal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of oxaliplatin and fluorouracil when administered with cetuximab and radiotherapy in patients with stage II or III squamous cell carcinoma of the esophagus. (Phase I)
- Determine the response rate in patients treated with this regimen. (Phase II)
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the postoperative complication rate and lethality in patients treated with this regimen.
- Determine the R0 resection rate in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the event-free survival of patients treated with this regimen.
- Determine the metabolic response rate in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 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 of the esophagus, meeting the following criteria:
- •Locally advanced disease (T3-T4, N0-N+ [T2, N0 for cervical esophageal carcinoma])
- •Potentially resectable disease
- •No distant metastases (M1b)
- •No tumor infiltration of the tracheobronchial system
- •Bartels preoperative risk analysis < 22
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
- •Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min
- •Bilirubin ≤ 1.5 mg/dL
- •ALT and AST ≤ 2 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2 times ULN
- •WBC ≥ 3,000/mm³
- •Granulocyte count ≥ 2,000/mm³
- •Platelet count ≥ 100,000/mm³
- •No pre-existing polyneuropathy > grade 1
- •No active uncontrolled infection
- •PaO_2 ≥ 60 mm Hg on room air
- •FEV_1 ≥ 60% of normal
- •No New York Heart Association class II-IV cardiac insufficiency
- •Ejection fraction ≥ 35%
- •No angina pectoris (at rest or under stress) unexplained by interventional cardiology
- •No myocardial infarction within the past 6 months
- •No histologically confirmed liver cirrhosis
- •No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanomatous skin cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy
- •No prior radiotherapy to the thorax region
- •No current esophageal stent
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of oxaliplatin and fluorouracil (Phase I)
Response rate (histological remission) (Phase II)
次要结局
- Toxicity as measured by NCI-CTC criteria
- Postoperative complication rate and lethality
- R0 resection rate
- Overall survival
- Event-free survival
- Metabolic response rate