A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma
- 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
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
To assess patient tolerance and toxicity of postoperative adjuvant regimen using epirubicin, cisplatin, and infusional 5-FU before and after a course of radiotherapy among patients with curatively resected gastric or gastroesophageal adenocarcinoma.
Charles S. Fuchs, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|