DRKS00025800招募中未知
HePro-TrialIntensity-modulated, hypofractionated radiotherapy with protons for hepatocellular carcinomas - a pilot study - HePro
niversitätsklinikum Essen, Klinik für Partikeltherapie, Westdeutsches Protonentherapiezentrum Essen (WPE)0 个研究点目标入组 50 人开始时间: 2021年7月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. HCC stage BCLC A or B confirmed histologically or by imaging
- •a. For definitive irradiation; or
- •b. As a bridging measure to transplantation.
- •2. Age = 18 years.
- •3. Surgery has been ruled out or patient admitted for transplant with expected waiting time for donor organ.
- •4. Activity status according to ECOG /WHO < 2.
- •5. Written informed consent to participate in the study.
- •6. Patients with portal hypertension or previously known esophageal varices: endoscopic examination and adequate therapy 3 months before study entry.
排除标准
- •1. Pre-irradiation in the area of the liver or SIRT.
- •2. Possibility of curative resection
- •3. Tumor stage BCLC C and D
- •4. Medical or psychiatric limitations that prevent the delivery of radiation treatment or affect compliance for treatment and follow-up
- •5. Pregnancy or unwillingness to use contraception
- •6. Ability to adequately spare surrounding gastrointestinal organs
- •7. Patients with Child-Pugh score B8-9 or C
- •8. Life expectancy < 3 months
- •9. Critical tumor to residual liver ratio (CTV liver >700cc)
- •10. Inadequate liver function defined as:
- •- Bilirubin > 3 mg/dl
- •- Albumin < 2.5 g/dl
- •11. Age < 18 years
- •12. No written consent to participate in the study
研究者
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