Spots Global Cancer Trial Database for Adjuvant Intraperitoneal Floxuridine Added to Chemoradiation for Fully Resected Advanced Stomach Cancer

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Trial Identification

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

Official Title: 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)

Study ID: NCT00858338

Conditions

Gastric Cancer

Stomach Cancer

Interventions

Potentially curative surgery

Floxuridine (IP)

Adjuvant Chemoradiation therapy

Study Description

Brief Summary: 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.

Detailed Description: 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.