INTERPERITONEAL FUDR PLUS RADIATION IN LOCALLY ADVANCED GASTRIC ADENOCARCINOMA

腹膜内 FUDR 联合放射治疗局部晚期胃腺癌

• 批准号: 7378295
• 负责人: FRANCO MUGGIA
• 金额: $ 4.3万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378295
• 关键词: INTERPERITONEAL; FUDR; PLUS; RADIATION; LOCALLY

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项在完全切除的局部晚期胃腺癌患者中进行的辅助腹膜间（IP）FUDR（尿苷）治疗的II期研究。患者将患有局部晚期疾病T2 a和T2 b伴淋巴结受累以及T3-T4伴或不伴淋巴结受累，均无转移。单纯手术不能治愈，且局部复发。该IP治疗用于腹膜和腹腔内淋巴结受累和肝转移。本研究将测试IP FUDR加入放化疗时的毒性和疗效。25例患者将在2家机构接受为期2.5年的研究。如果成功，将启动第三阶段试验。将研究2个队列：1）IP FUDR+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已开始入组。目前还没有结果。