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)
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
toxicity of IP FUDR after surgery prior to chemoradiation
6 months
Yes
Franco Muggia, MD
Principal Investigator
New York University School of Medicine
United States: Food and Drug Administration
02-51 (H 10610)
NCT00858338
December 2002
February 2012
Name | Location |
---|---|
Bellevue Hospital | New York, New York 10016 |
NYU Cancer Center | New York, New York 10016 |
NYU Tisch Hospital | New York, New York 10016 |