Protocol Title:

Phase III Intergroup Trial of Adjuvant Chemoradiation
after Resection of Gastric or Gastroesophageal Adenocarcinoma

Protocol Status:

Open

Protocol Number:

CALGB 80101

Type of Cancer:

Gastric or Gastroesophageal Cancer

Principal Investigator:

Joseph Herman, M.D.

Research Nurse:

Beth Griffith, R.N.

Phase Number:

III

General Eligibility:

Patients can be male or female of any race and greater than or equal to 18 years of age. Patients must have had a total resection of gastric or gastroesophageal cancer with no metastatses. Patients can not have had any previous chemotherapy or radiotherapy. Only patients who are between 3 and 12 weeks post disease resection can participate.

Purpose:

To compare overall survival in patients with resected gastric adenocarcinoma treated with epirubicin, cisplatin, and infusional fluorouracil (5-FU) vs 5-FU bolus and leucovorin calcium before and after 5-FU plus radiotherapy. To compare disease-free survival and local and distant recurrence rates in these patients treated with these regimens.

Treatment:

This is a randomized, multicenter study.

Arm I: Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days between course 2 and 3.

Arm II: Patients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.

Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually for 3 years.

Projected Accrual:

A total of 824 patients will be accrued for this study.