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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
1 year
No
Franco Muggia, MD
Principal Investigator
New York University School of Medicine
United States: Food and Drug Administration
07-837
NCT00848783
May 2008
September 2012
Name | Location |
---|---|
Norris Cancer Center | Los Angeles, California 90033 |
Bellevue Hospital | New York, New York 10016 |
NYU Cancer Center | New York, New York 10016 |