Gastric Cancer Clinical Trial
Official title:
A Randomized Phase-II Study of Patients With Locally Advanced Gastric of Gastro-Esophageal Adenocarcinoma Treated With Induction Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Adjuvant Intraperitoneal Floxuridine, Followed by Prolonged Administration of Capecitabine
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.
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