A Phase II Trial of Pre- and Postoperative Chemoradiotherapy and ZD1839 (IRESSA) Followed by Maintenance ZD1839 in Patients With Locoregionally Advanced Esophageal and Gastroesophageal Junction Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Survival at 1 year
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Cisplatin and fluorouracil may also make tumor cells more sensitive to radiation therapy. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with combination therapy and gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy and gefitinib before and after surgery works in treating patients with advanced esophageal or gastroesophageal junction cancer.
详细描述
OBJECTIVES:
Primary
- Determine the activity of gefitinib, in terms of median survival and distant metastatic disease control, in patients treated with neoadjuvant and adjuvant cisplatin, fluorouracil, and radiotherapy who are undergoing surgery for esophageal and gastroesophageal junction cancer.
Secondary
- Determine the pathologic complete and partial response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients and in patients who are disease free and receiving long-term maintenance gefitinib.
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or large cell undifferentiated cancer of the esophagus or gastroesophageal junction
- •T3, N1, or M1a disease only
- •The following types are not allowed:
- •Small cell undifferentiated carcinomas, lymphomas, or sarcomas
- •Small cell or mixed small cell/non-small cell histology
- •No evidence of distant hematogenous tumor metastases (M1b)
- •No malignant pleural effusions
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC > 3,500/mm^3
- •Platelet count > 100,000/mm^3
- •Alkaline phosphatase < 2 times normal
- •AST < 2 times normal
- •No unstable or uncompensated hepatic disease
- •Creatinine ≤ 2.0 mg/dL
- •Calcium normal
- •No unstable or uncompensated renal disease
- •Cardiovascular
- •No unstable or uncontrolled angina
- •No unstable or uncompensated cardiac disease
- •See Disease Characteristics
- •No limitations to pulmonary function that would preclude study participation
- •No evidence of clinically active interstitial lung disease (asymptomatic patients with chronic stable radiographic changes are allowed)
- •No unstable or uncompensated respiratory disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No evidence of severe or uncontrolled systemic disease
- •No other uncontrolled malignancy
- •No active infection
- •No known severe hypersensitivity to gefitinib or any of its excipients
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior immunotherapy for this cancer
- •Chemotherapy
- •No prior chemotherapy for this cancer
- •Radiotherapy
- •No prior radiotherapy for this cancer
- •Recovered from any prior oncologic or other major surgery
- •No prior surgical resection for this cancer
- •No concurrent ophthalmic surgery
- •No prior photodynamic therapy for this cancer (prior laser treatments are acceptable)
- •More than 30 days since prior unapproved or investigational drug
- •No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)
排除标准
- 未提供
结局指标
主要结局
Survival at 1 year
时间窗: 1 year
Survival at 1 year
Distant metastatic control at 1 year
时间窗: 1 year
Distant metastatic control at 1 year
次要结局
- Response rate at 6 weeks(6 weeks)
- Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks(6 weeks)
- Toxicity of maintenance gefitinib as measured by CTC version 2.0 every 8 weeks after the completion of radiotherapy(8 weeks)