Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junction, or Stomach

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

January 5, 2008

Primary Completion Date

March 26, 2012

Study Completion Date

January 23, 2015

Conditions
Esophageal CancerGastric Cancer
Interventions
DRUG

cisplatin

20 mg/m2/day IV continuous infusion over 24 hours for 96 total hours.

DRUG

epirubicin hydrochloride

50 mg/m2 IV bolus

DRUG

fluorouracil

200 mg/m2/day will be given as a continuous intravenous infusion for all 9 weeks, beginning on day 1.

DRUG

oxaliplatin

130 mg/m2 IV infusion over 2 hours

PROCEDURE

adjuvant therapy

Between 6-10 weeks after surgery patients will begin postoperative chemoradiotherapy. Daily radiation therapy fractions of 180-200 cGy will be given to the esophago-gastric bed and draining lymphatic regions to a total dose of 50-55 Gy (60 Gy in the event of an R1 or R2 resection). Concurrent with this radiation, two cycles of chemotherapy will be given, during the first and fourth weeks of the radiation

PROCEDURE

neoadjuvant therapy

"Three weeks after discontinuing the fluorouracil (12 weeks after study entry) patients will be fully restaged to assess for a clinical response, and to ensure that there is no contraindication to surgical resection, which will be scheduled for approximately one week later (13 weeks after study entry).~Surgery will consist of a transthoracic esophagogastrectomy or a total gastrectomy with Roux-en-Y esophagojejunostomy depending on the location and extent of the tumor at surgery. An appropriate lymphadenectomy will be performed. Immediate reconstruction is anticipated if possible."

Trial Locations (1)

44106-5065

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Case Comprehensive Cancer Center

OTHER

NCT00601705 - Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junction, or Stomach | Biotech Hunter | Biotech Hunter