Treatment of Patients With Hepatic Neuroendocrine Metastases Using Drug-Eluting Bead Embolization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Infusing doxorubicin beads into the liver, and blocking blood flow to the tumor, may keep doxorubicin near the tumor and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects of doxorubicin beads and to see how well they work in treating patients with unresectable liver metastases from neuroendocrine tumors.
详细描述
OBJECTIVES:
Primary
- To gather preliminary data and determine the feasibility of a randomized study of patients with unresectable hepatic neuroendocrine metastases using PVA microporous hydrospheres/doxorubicin hydrochloride.
OUTLINE: A catheter is placed into the right or left hepatic artery. Patients with unifocal tumors will have the catheter or microcatheter placed more selectively into the 2nd or 3rd order branch off the right or left hepatic artery in closer proximity to the tumor. Polyvinyl alcohol (PVA) microporous hydrospheres/doxorubicin hydrochloride mixture is injected into the delivery area.
Patients with less than 75% necrosis at 1 month undergo a second (and possibly a third a month later) chemoembolization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DEB-TACE
PVA microporous hydrospheres loaded with doxorubicin hydrochloride used for the treatment of unresectable liver metastases from neuroendocrine tumors.
干预措施: PVA microporous hydrospheres/doxorubicin hydrochloride (Drug)
结局指标
主要结局
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
时间窗: 1 month after initial DEB-TACE treatment
Safety was assessed at each DEB-TACE procedure and at every follow-up thereafter according to National Cancer Institute Common Toxicity Criteria (CTCAE) v3.0. The study was prematurely terminated due to high incidence of biloma and liver abscess. Safety data below is based off of 13 patients enrolled on protocol at 1 month post initial treatment.
次要结局
- Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria(12 months)
- Survival(overall survival)
- Biochemical Response - Time to Progression(Time to progression, 12 months)
- Symptomatic Response by Assessing Symptom Severity in Patients(Duration of study participation, average of 12 months)
研究者
Jeff Geschwind
Professor of Radiology and Oncology
Yale University