Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,499
- 试验地点
- 1
- 主要终点
- Response
研究概览
简要总结
The investigators aim to explore the efficacy of [90Y-DOTA]-TOC and [177LuDOTA]-TOC therapy in advanced neuroendocrine cancer. Therefore, the investigators assess response, survival and long-term safety profile of systemic [90Y-DOTA]-TOC and [177LuDOTA]-TOC treatment in metastasized neuroendocrine cancer patients. Adverse events are assessed according to the criteria of the National Cancer Institute. Survival analyses are performed using multiple regression models.
详细描述
Background: Systemic treatment with the 90Yttrium (90Y) labeled, tetraazacyclododecanetetraacetic acid (DOTA) modified somatostatin analog Tyr3-octreotide (TOC) was introduced in 1998 (Otte et al. Lancet 1998). [90Y-DOTA]-TOC is administered intravenously and binds to the somatostatin receptor subtype 2, located on the surface of the tumor cell, and exerts its cytotoxic effects by β-irradiation. The treatment has moderate acute hematologic and nephrologic toxicity and has developed into a promising therapeutic tool for tumors expressing its target receptor (Iten et al. Clin Cancer Res 2007, Iten et al. Cancer 2009).
Study Aim: To explore the efficacy of [90Y-DOTA]-TOC and [177LuDOTA]-TOC therapy in advanced neuroendocrine cancer.
Study Hypothesis: Response to DOTA-TOC is correlated with prolonged survival.
Study Type: Clinical phase II, single-center, open-label trial
Patients: 1500 patients
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed neuroendocrine cancer
- •stage IVc disease by definition of the American Joint Committee on Cancer, i.e. occurrence of distant metastases
- •visible tumor uptake in the pretherapeutic somatostatin receptor subtype 2 scintigraphy (111In-Octreoscan)
排除标准
- •concurrent anti-tumor treatment
- •secondary malignancies
- •pregnancy
- •breast-feeding
- •incontinence
- •severe concomitant illness including severe psychiatric disorders
研究组 & 干预措施
DOTA-TOC
Treatment arm
干预措施: DOTA-TOC Treatment (Drug)
结局指标
主要结局
Response
时间窗: 3 months
次要结局
- Toxicity(3 months)
- Survival(life-long)