Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

Dana-Farber Cancer Institute

Status and phase

Completed

Early Phase 1

Conditions

Gastro-esophageal Junction Cancer

Gastric Cancer

Stomach Cancer

Treatments

Drug: Cisplatin

Procedure: Radiation

Drug: 5-Fluorouracil (5-FU)

Drug: Epirubicin

Study type

Interventional

Funder types

Other

Identifiers

NCT00215514

00-165

Details and patient eligibility

About

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.

Full description

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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