28
Participants
Start Date
December 31, 2002
Primary Completion Date
March 31, 2007
Study Completion Date
February 29, 2012
Potentially curative surgery
"Surgery:~Week 1: Potentially curative surgery. If the tumor successfully resected (microscopically disease-free margins, Ro, with regional lymphadenectomy for proper staging), the ip catheter in place.~Weeks 2-4: Recovery. Then continue to adjuvant IP chemotherapy."
Floxuridine (IP)
"Adjuvant IP Chemotherapy:~week 1: ip Floxuridine 3 gm/day, days 1,2,3. week 2: 1 week without treatment. week 3: ip Floxuridine 3 gm/day protocol days 15,16,17. week 4: 1 week without treatment. Then continue to chemoradiation therapy."
Adjuvant Chemoradiation therapy
"Adjuvant Chemoradiation therapy:~week 1: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU 400 mg/m2 + LV 20 mg/m2 each day on days 1-4; week 9: 5-FU 400 mg/m2 + LV 20 mg/m2 each day on days 1-3; week 14: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days; week 19: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days."
Bellevue Hospital, New York
NYU Cancer Center, New York
NYU Tisch Hospital, New York
NYU Langone Health
OTHER
Food and Drug Administration (FDA)
FED