Neoplasms

Digestive System Diseases

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Stomach Neoplasms

Adenocarcinoma

Gastrointestinal Neoplasms

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Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Leucovorin

Fluorouracil

Floxuridine

Antimetabolites

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.

Potentially curative surgery

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.

Floxuridine (IP)

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.

Adjuvant Chemoradiation therapy

Franco Muggia, MD

This study is to evaluate the efficacy and safety of addition of intraperitoneal (ip) Floxuridine to adjuvant chemoradiation therapy for patients under-going potentially curative stomach resection.

Most patients diagnosed with stomach cancer in the US fail to be cured by gastric resection, and most trials of adjuvant chemotherapy do not improve survival rates. However, it has shown that chemo-radiotherapy can substantially increase survival rates after gastric resection in a recent intergroup randomized study (INT 0116) that used adjuvant chemoradiation of 5-fluorouracil (5-FU) and leucovorin concurrently with total dose of 4500 cGy of external-beam radiation treatment (RT) to the abdominal tumor nodal field in patients with resected, locally advanced gastric cancer. However, since the most common recurrences in both arms (surgery only vs. surgery followed by chemoradiation) were regional, typically abdominal carcinomatosis, this may indicate the need for adjuvant ip floxuridine to be added to adjuvant chemoradiation. Our experience for ip floxuridine leads us to hypothesize that the addition of this type of therapy to adjuvant chemoradiation may further increase the cure-rate for patient under-going potentially curative gastric resection. It seems important to convincingly demonstrate the effect of ip floxuridine treatment combined with the chemoradiation regimen. This became the basis for the design of this Phase II study, which will test the toxicity and efficacy of ip floxuridine added to chemo-radiation of the INT 0116 study. The protocol is to be completed in three years, and it may become a springboard for planning and initiation of a pivotal multi-institutional trials.

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

Phase-II Study of Adjuvant Intraperitoneal FUDR Treatment Added to Chemoradiation (5-fluorouracil/Leucovorin Plus Total Dose 4500 cGy of External Beam Radiotherapy) in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma (R0 Resection and at Least D1 Lymph-node Dissection)

every 4 months the first year after treatment; every 6 months 2nd and 3rd year; yearly thereafter up to a total 10 years

Food and Drug Administration (FDA)

NYU Langone Health

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjuvant Intraperitoneal Floxuridine Added to Chemoradiation for Fully Resected Advanced Stomach Cancer	NCT00858338	Gastric Cancer Stomach Cancer	Potentially cur... Floxuridine (IP... Adjuvant Chemor...	18 Years -	NYU Langone Health
Adjuvant Intraperitoneal Floxuridine Added to Chemoradiation for Fully Resected Advanced Stomach Cancer	NCT00858338	Gastric Cancer Stomach Cancer	Potentially cur... Floxuridine (IP... Adjuvant Chemor...	18 Years -	NYU Langone Health
Adjuvant Intraperitoneal Floxuridine Added to Chemoradiation for Fully Resected Advanced Stomach Cancer	NCT00858338	Gastric Cancer Stomach Cancer	Potentially cur... Floxuridine (IP... Adjuvant Chemor...	18 Years -	NYU Langone Health

Spots Global Cancer Trial Database for locally advanced stomach cancer