DRKS00027117招募中不适用
Prospective evaluation of the safety and efficacy of MR-guided single-fraction stereotactic ablative radiotherapy for unresectable primary or secondary liver tumors - SINGLE SHOT LIVER - SINGLE SHOT LIVER
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU München0 个研究点目标入组 35 人开始时间: 2021年11月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. 1-3 unresectable liver tumors (primary and secondary liver tumors); not immediately adjacent to high-risk organs of the gastrointestinal tract (stomach, duodenum, jejunum/ileum, colon, etc.). Imaging diagnosis of HCC is sufficient with no need for additional biopsy
- •2. 1-3 liver metastases in patients with previously histologically confirmed carcinomas (no hematologic or germ cell tumors); not immediately adjacent to high-risk organs of the gastrointestinal tract (stomach, duodenum, jejunum/ileum, colon, etc.). Biopsy of metastases for histologically confirmed primarary tumor is not required
- •3. Maximum diameter of a single metastasis = 5cm
- •4. Non-resectable metastases; patient is not eligible for or refuses surgery
- •5. Age = 18 years
- •6. ECOG Performance Status = 2
- •7. Indication for radiotherapy (SBRT) confirmed at the multidisciplinary tumor board
- •8. Previous surgery, systemic and local ablative therapies (RFA, SBRT, brachytherapy etc.) are allowed
- •9. Convalescence from previous therapy (such as surgery, systemic therapy or radiotherapy in other regions) with an appropriate interval
- •10. Adequate liver function
- •11. Patients are able to understand and willing to sign an IRB-approved informed consent document and adhere to the conditions of the study
排除标准
- •1. Known contraindications for radiotherapy e.g. severe comorbidities
- •2. Significant overlap with a previously treated radiation volume - prior radiotherapy is generally allowed as long as all dose requirements are met in the composite plan (biologically effective doses are calculated for this purpose).
- •3. Pregnant and/or breastfeeding
- •4. Medical or psychological impairments that do not allow proper informed consent or trial participation
- •5. Lack of legal capacity
研究者
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