NCT00215514已完成早期 1 期
A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- To assess patient tolerance and toxicity of postoperative adjuvant regimen using epirubicin, cisplatin, and infusional 5-FU before and after a course of radiotherapy among patients with curatively resected gastric or gastroesophageal adenocarcinoma.
研究概览
简要总结
The main purpose of this trial is to determine how well patients with gastric or gastroesophageal junction adenocarcinoma respond to chemotherapy with epirubicin, cisplatin and 5-fluorouracil followed by continuous infusion 5-fluorouracil chemotherapy given along with radiation therapy.
详细描述
- Patients will receive epirubicin and cisplatin intravenously on day 1 of treatment. 5-fluorouracil will be given continuously by intravenous infusion bia a portable ambulatory pump (CADD pump) for 21 days. This cycle of chemotherapy will take 21 days (3 weeks). Once it is complete there will be one week without therapy.
- Once the patient has recovered from any side-effects from the chemotherapy they will start the combination chemoradiation therapy, 5-fluorouracil and radiation. The radiation will be directed to the upper abdomen in the area where the stomach tumor has been located. The radiation therapy will be given five days a week for a total of five weeks. During these five weeks patients will receive 5-fluorouracil continuously by CADD pump.
- After completion of combination chemoradiation therapy there will be a three to four week rest period followed by 2 additional chemotherapy cycles identical to the first chemotherapy cycle.
- The following tests and procedures will be performed: physical examination every 4 weeks except during the chemoradiation therapy when it will be done weekly; blood tests every week during chemotherapy and chemoradiation; CT scans and chest x-rays done before therapy, at the end of therapy, and yearly for 2 years; noninvasive testing to evaluate kidney function before starting the study.
- The program of chemotherapy and radiation therapy will last approximately 30 weeks. After all treatment is completed, patients will return for physical examinations and blood tests every 3 months for 3 years; then every 6 months for 2 years.
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
- Prevention
- 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
- •Patients must have adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible.
- •Patients must have had en bloc resection of all known tumor and be at high risk for later failure. The surgical resection must have been done with a curative intent. The stomach, lver, peritoneum, omentum and regional lymph nodes must be evaluated and all identified tumor be resected.
- •The surgical specimen, and the pathologic analysis thereof, must be adequate for TNM staging.
- •Treatment must begin between day 20 and day 56 after the gastrectomy.
- •ECOG performance status of 0,1 or 2
- •ANC > 1,500/ul and platelet count >100,000/ul
- •Serum creatinine < 1.5mg/dl
- •Total bilirubin < 2.0 mg/dl and AST < 3 x ULN
- •Estimated caloric intake of 1500K calories per day or greater
排除标准
- •Known unresected cancer, microscopic evidence of tumor at the line of resection, noncontiguous resection of tumor, or M1 disease
- •Ascites, peritoneal seeding, liver metastasis or extra-abdominal metastasis
- •Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, non-invasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years
- •Previous chemotherapy or radiotherapy
- •Active infectious process
- •Pregnant or lactating women
- •Myocardial infarction in the past 6 months or prior history of congestive heart failure or significant valvular heart disease
- •Uncontrolled serious medical or psychiatric condition
- •Grade 2 or greater peripheral neuropathy at baseline
研究组 & 干预措施
ECF followed by 5-FU/RT followed by ECF
Experimental
干预措施: Epirubicin (Drug)
ECF followed by 5-FU/RT followed by ECF
Experimental
干预措施: Cisplatin (Drug)
ECF followed by 5-FU/RT followed by ECF
Experimental
干预措施: 5-Fluorouracil (5-FU) (Drug)
ECF followed by 5-FU/RT followed by ECF
Experimental
干预措施: Radiation (Procedure)
结局指标
主要结局
To assess patient tolerance and toxicity of postoperative adjuvant regimen using epirubicin, cisplatin, and infusional 5-FU before and after a course of radiotherapy among patients with curatively resected gastric or gastroesophageal adenocarcinoma.
时间窗: 3 years
次要结局
未报告次要终点
研究者
Charles S. Fuchs, MD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (3)
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