Background: The goals of this study were to assess the feasibility and toxi
city of a regimen of preoperative chemoradiotherapy, surgery, and intraoper
ative radiotherapy in the treatment of patients with potentially resectable
gastric cancer. A secondary objective was to assess pathologic response to
chemoradiotherapy in the treated tumors.
Methods: Twenty-four patients were entered in the protocol. Treatment regim
en consisted of 45 Gy of external beam radiotherapy with concurrent 5-FU gi
ven as a continuous infusion at a dose of 300 mg/m(2). Patients were restag
ed 4-6 weeks after chemoradiotherapy and then underwent surgical resection
acid intraoperative radiotherapy to a dose of 10 Gy.
Results: Twenty-three patients (96%) completed chemoradiotherapy in accorda
nce with the study protocol. Nineteen (83%) of 23 patients who completed ch
emoradiotherapy underwent surgical resection with D2 lymphadenectomy. Four
patients (17%) had progressive disease and were not resected. The morbidity
and mortality rates were 32% and 5%, respectively. Of the resected patient
s, two (11%) had complete pathologic responses while 12 (63%) had pathologi
c evidence of significant treatment effect.
Conclusions: Preoperative chemoradiotherapy for gastric cancer can be deliv
ered safely and is well tolerated. The rate of surgical complications is co
nsistent with that of other recently reported prospective trials of gastrec
tomy alone. Preoperative chemoradiotherapy resulted in significant patholog
ic responses in the majority of treated tumors, and complete pathologic res
ponses were achieved in some patients.