Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- tumor free survival
研究概览
简要总结
The purpose of this study is to show the tumor free long term survival of patients with isolated non-resectable liver metastases of neuroendocrine tumors after neo-adjuvant radio receptor treatment and following liver transplantation.
详细描述
Matching patient will be treated neo-adjuvant at the hospital with 177 Lutetium peptide receptor radiotherapy in two following courses. After this treatment it will follow the liver transplantation within 9 month as postmortal or living donor liver transplantation.
Under certain conditions concerning the evaluation examinations patients can be included in the study.
Most important factors are no evidence of disease outside the liver, removed primary tumor, patients between 18 and 60 years, no curative surgical resection of the liver metastasis possible.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 60 years
- •neuroendocrine Tumor with low or intermediate malignant histological appearance
- •primary tumor removed, no extrahepatic tumor
- •liver metastasis not resectable
- •positive evaluation for liver transplantation
- •primary tumor drained by vena porta
- •tumor load within the liver < 50%
- •stable disease after receptor therapy with 177 Lutetium for 6 month
排除标准
- •prognostic relevant second tumor disease
- •pregnancy
- •undifferentiated neuroendocrine carcinoma (WHO II, G3)
- •renal insufficiency > second degree
- •progressive carcinoid conditioned heart disease (>NYHA II)
- •Karnofsky-Index < 60
结局指标
主要结局
tumor free survival
时间窗: 5 years
次要结局
- quality of life(5 years)