SURGICAL DEBULKING PLUS OCTREOTIDE VERSUS OCTREOTIDE ALONE IN ACROMEGALY

肢端肥大症手术减瘤联合奥曲肽与单独奥曲肽的比较

• 批准号: 7378336
• 负责人: DAVID L KLEINBERG
• 金额: $ 0.61万
• 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/7378336
• 关键词: SURGICAL; DEBULKING; PLUS; OCTREOTIDE; VERSUS

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 multicenter, investigator-initiated randomized study of long-acting octreotide (Sandostatin) alone vs. surgical debulking plus octreotide in acromegaly to determine if surgical debulking improves treatment effect. Data on currently available treatments (surgery, somatostatin analogs) are often difficult to compare, and no randomized trials have been completed. Subjects will be randomized to Arm A or B (1:2 ratio). Arm A begins with medical treatment alone: Patients are followed for 3 doses on Sandostatin. Arm B begins with surgical treatment alone. If after surgery the patient is not cured, the patient will go on Sandostatin for 3 doses (over 3 months). Endpoints are functional measures (IGF-I) and tumor size (MRI). The study may lead to a change in the initial management of patients, because surgery of macroadenomas of this sort is not initial treatment.

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。这是一项多中心、由医生发起的随机研究，比较长效奥曲肽（善得定）单药与手术减积加奥曲肽治疗肢端肥大症，以确定手术减积是否能改善治疗效果。目前可用的治疗（手术，生长抑素类似物）的数据往往很难比较，没有随机试验已经完成。受试者将随机分配至A组或B组（1：2比例）。A组从单独的药物治疗开始：对患者进行3次Sandostatin剂量的随访。B组开始时仅进行手术治疗。如果手术后患者未治愈，患者将继续服用善得定3剂（超过3个月）。终点是功能测量（IGF-I）和肿瘤大小（MRI）。这项研究可能会导致患者初始治疗的改变，因为这种大腺瘤的手术不是初始治疗。