This study is to determine whether intraperitoneal (IP) Floxuridine is effective in the patients with advanced stomach or gastro-esophageal junction cancers in the treatment consisting of pre- and post-surgery chemotherapies.
A previous Phase-II trial conducted by the same principle investigator(s), utilizing preoperative chemotherapy and intraperitoneal consolidation, was conducted in patients with locally advanced, potentially resectable gastric cancer or cancer of the gastro-esophageal junction (GEJ), both staged as T3N0, T4N0, any TN1 or TN2 disease. The data suggest that for patients with locally advanced gastric or GEJ cancer, systemic induction therapy, curative surgery with high Ro resection rates, and IP adjuvant therapy, has acceptable toxicity and encouraging survival outcome. The Medical Research Council Adjuvant Gastric Infusional Chemotherapy (MAGIC) trial has also shown that perioperative chemotherapy - chemotherapy given both before and after surgery - can provide a significant survival benefit. The investigators hypothesize that adjuvant intraperitoneal salvage of cancer micrometastatic residues after surgery contributes to disease-free survival. The goal of this trial is to determine whether IP Floxuridine, added to adjuvant postoperative chemotherapy, prolongs patient's survival. This will be tested during the randomized open-label trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Norris Cancer Center
Los Angeles, California, United States
Bellevue Hospital
New York, New York, United States
NYU Cancer Center
New York, New York, United States
Number of Patients With One-year Recurrence-free Survival
This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy.
Time frame: 1 year
Overall Survival Rate; Toxicity; Evaluation of Sites of Relapse of Failing Patients
Secondary outcome measure was not analyzed as study was terminated
Time frame: every 4 months for the first 2 years, every 6 months for years 3 and 4, then every 12 months for up to 10 years
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