INTERPERITONEAL FUDR PLUS RADIATION IN LOCALLY ADVANCED GASTRIC ADENOCARCINOMA

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项II期研究，辅助性腹膜间(IP)氟尿嘧啶(FUDR)治疗局部进展期胃腺癌患者。患者将有局部晚期疾病T2a和T2b伴淋巴结转移，T3-T4伴或不伴淋巴结转移，均无转移。单靠手术是不能治愈的，而且会出现区域性复发。这种IP疗法适用于腹膜和腹内淋巴转移和肝转移。这项研究将测试IP FUDR在化疗中的毒性和疗效。25名患者将在两个机构进行为期2.5年的研究。如果成功，将启动第三阶段试验。将对2个队列进行研究：1)ip FUDR加放化疗；2)单独放化疗。主要终点是疾病复发。初步结果是积极的。GCRC的招生工作已经开始。目前还没有结果。

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.