adjuvant chemoradiation therapy for gastric or gastroesophageal junction adenocarcinoma

Conditions: Stomach Cancer; Gastric Cancer; Gastro-esophageal Junction Cancer

Summary: 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.

* 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.

Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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

Keywords: adjuvant chemoradiation ge junction epirubicin