A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 55
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer.
详细描述
OBJECTIVES:
- Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach.
- Determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1-21, cisplatin IV over 1 hour on days 1-5, and leucovorin calcium IV over 15 minutes on days 1, 8, 15, and 22. A second course is administered beginning on day 29.
Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest (day 57). Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1, 8, 15, 22, and 29.
Approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic disease undergo surgical resection.
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
- 0 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven adenocarcinoma of the stomach
- •Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0)
- •No lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes)
- •Potentially resectable
- •May involve the gastroesophageal junction, but bulk of tumor must be in the stomach
- •No distant metastases
- •No pleural or pericardial effusion
- •No peritoneal disease diagnosed by laparoscopy
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •At least 16 weeks
- •Hematopoietic:
- •Absolute granulocyte count greater than 2,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •Creatinine less than 1.5 mg/dL
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No hypertension
- •Neurologic:
- •No cerebrovascular disease
- •No diabetic neuropathy
- •No mental status abnormalities
- •No uncontrolled diabetes
- •No infection
- •No other malignancies within past 5 years except resected squamous cell or basal cell skin cancer
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior immunotherapy
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to stomach
- •No prior surgery to stomach
排除标准
- 未提供