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.
* 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
25
Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> One-week rest --\> External Beam Radiation Therapy plus 5-FU CI --\> Four-week rest --\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> One-week rest --\> External Beam Radiation Therapy plus 5-FU CI --\> Four-week rest --\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> One-week rest --\> External Beam Radiation Therapy plus 5-FU CI --\> Four-week rest --\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
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.
Time frame: 3 years
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Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> One-week rest --\> External Beam Radiation Therapy plus 5-FU CI --\> Four-week rest --\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).