Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

Completed · Early Phase 1

Conditions studied: Stomach Cancer, Gastric Cancer, Gastro-esophageal Junction Cancer

In brief

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.

Key facts

Study ID

NCT00215514

Run by

Dana-Farber Cancer Institute

People needed

25

Starts

2000-09-01

Expected to finish

2014-07-01

Last updated by the study team

2014-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.