Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Cisplatin; Epirubicin; Fluorouracil

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