INTERPERITONEAL FUDR PLUS RADIATION IN LOCALLY ADVANCED GASTRIC ADENOCARCINOMA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase II study of adjuvant interperitoneal (IP) FUDR (floxuridine) treatment in patients with fully resected locally advanced gastric adenocarcinoma. Patients will have local advanced disease T2a and T2b with lymph-node involvement and T3-T4 with or without lymph-node involvement, all without metastases. Surgery alone is not curative and recurrences regional. The use of this IP treatment is for peritoneal and intra-abdominal lymph-node involvement and liver metastases. This study will test the toxicity and efficacy of IP FUDR when added to chemoradiation. 25 patients will be studied over 2.5 years in 2 institutions. If successful, a phase III trial will be initiated. 2 cohorts will be studied: 1) with IP FUDR plus chemoradiation; 2) with chemoradiation alone. The primary endpoint is disease relapse. Preliminary results are positive. Enrollment has begun on the GCRC. No results have emerged yet.