Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
Prospective single arm, single center observational study to evaluate Quality of Life (Qol) after stereotactic body radiotherapy for patients with hepatocellular cancer. Patients will receive work-up, treatment and follow-up exclusively as routinely done except additional quality of life measurements. Qol will be measured by standardized and validated EORTC questionaires at different time points during routine follow-up.
详细描述
Prospective single arm, single center observational study to evaluate Quality of Life (Qol) after stereotactic body radiotherapy (SBRT) for patients with hepatocellular cancer (HCC). Patients will receive work-up, treatment and follow-up exclusively as routinely done except additional quality of life measurements. This will include contrast-enhanced liver MRI or CT and placement of fiducials if necessary. Radiation treatment planning will be based on contrast-enhanced fourdimensional computed tomography (4D-CT) with abdominal compression. Target volume definition will use an internal target volume (ITV) concept. Dose prescription and fractionation will be prescribed individually based on lesion size, localisation, movement and liver function according to institutional standards. Qol will be measured by standardized and validated EORTC questionaires (QLQ C-30 and HCC 18) at baseline, at the end of SBRT, during follow up at 6 weeks, 3,6,12,24,36,48 and 60 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically or radiologically proven hepatocellular carcinoma
- •1-3 lesions suitable for stereotactic radiation therapy
- •indication for SBRT according to multidisciplinary board evaluation
- •age >= 18 years
- •written informed consent for study participation
- •mental and verbal ability to complete standardized questionaires according to assessment by investigator (physician)
排除标准
- •age < 18 years
- •prior HCC specific systemic therapy
- •concurrent oncological systemic treatment
- •distant metastases
- •inadequate ability tobe compliant with the protocol or to complete standardizes questionaires
- •inability to receive contrast-enhanced planning CT
- •missing ability to give informed consent
- •legal custody
结局指标
主要结局
Quality of life
时间窗: 60 months
Quality of life
次要结局
- correlation Qol with late toxicity(6, 12, 24, 36, 48, 60 months)
- hepatic control(60 months)
- overall survival(60 months)
- acute toxicity(3 months)
- late toxicity(6, 12, 24, 36, 48, 60 months)
- freedom from treatment failure(60 months)
- response(3 months)
- local control(60 months)
- pattern of recurrence(60 months)
- distant control(60 months)
- correlation Qol with acute toxicity(3 months)
研究者
Falk Roeder
Consultant Radiation Oncology
Ludwig-Maximilians - University of Munich