Best Therapy for Patients With Neuroendocrine Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
A prospective observational study containing three arms comprising different therapeutic measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor radiotherapy.
详细描述
Study design:
Prospective observational study comparing ablative measures as TACE or SIRT with surgery/RFA and with peptide receptor radio-therapy in patients with advanced well-differentiated neuroendocrine tumors with lymph node or distant metastases (N1, M1) Prospective evaluation Primary end points: time to progression Secondary end points: survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index) Non-randomized cohort study Number of patients needed in all groups: 70 per group, 210 overall Evaluation of response to therapy every 3-6 months by imaging, clinical status, weight, quality of life, Karnofsky-index Cross-over allowed if therapy changes
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven neuroendocrine tumor (WHO class I-II, TNM grading 1-2)
- •Advanced disease with lymph node or distant metastases (N1, M1) undergoing cytoreduction by surgery/local ablative therapy or peptide receptor radiotherapy
- •curative intent of all therapies possible
排除标准
- •Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3)
- •secondary tumor
- •advanced carcinoid heart disease requiring surgery
结局指标
主要结局
progression-free survival
时间窗: 2 years
次要结局
- overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index(2 years)
研究者
Dieter Hoersch MD
Senior consultant
Zentralklinik Bad Berka