61
Participants
Start Date
January 5, 2008
Primary Completion Date
March 26, 2012
Study Completion Date
January 23, 2015
cisplatin
20 mg/m2/day IV continuous infusion over 24 hours for 96 total hours.
epirubicin hydrochloride
50 mg/m2 IV bolus
fluorouracil
200 mg/m2/day will be given as a continuous intravenous infusion for all 9 weeks, beginning on day 1.
oxaliplatin
130 mg/m2 IV infusion over 2 hours
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
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."
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland
National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER