Adjuvant Intraperitoneal Floxuridine Added to Chemoradiation for Fully Resected Advanced Stomach Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 31, 2002

Primary Completion Date

March 31, 2007

Study Completion Date

February 29, 2012

Conditions
Gastric CancerStomach Cancer
Interventions
PROCEDURE

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."

DRUG

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."

PROCEDURE

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."

Trial Locations (3)

10016

Bellevue Hospital, New York

NYU Cancer Center, New York

NYU Tisch Hospital, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER

collaborator

Food and Drug Administration (FDA)

FED

NCT00858338 - Adjuvant Intraperitoneal Floxuridine Added to Chemoradiation for Fully Resected Advanced Stomach Cancer | Biotech Hunter | Biotech Hunter