Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Response to therapy
研究概览
简要总结
The TNTRect trial is a prospective observational study that will evaluate the outcome of MR-guided stereotactic body radiotherapy (SBRT) with a simultaneous integrated boost in a hypofractionated treatment of rectum cancer. Patients will be treated in 5 daily fractions of 5 Gy within an overall treatment time (OTT) of 5 days. A simultaneous integrated boost (SIB) till 30Gy will be delivered to the gross tumor volume. Patients will be treated with daily adaptive radiotherapy and online tumor gating on the MRIdian system (ViewRay Inc.). The aim of the study is to improve the complete clinical response rate to offer more patients an organ preserving approach.
The primary endpoint is patient response to the treatment, assessed by endoscopy and MRI, or by medical pathology reports after potential resection was performed. As secondary endpoints local control, disease-free survival, overall survival and the patient's quality of life & hospital anxiety and depression will be measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Locally advanced rectal cancer
排除标准
- •Patients with unresectable metastatic disease at diagnosis
- •Patients with an ECOG performance status > 2
- •Patients not deemed fit for radiotherapy, chemotherapy or surgery
结局指标
主要结局
Response to therapy
时间窗: up to 25 weeks after start of radiotherapy
After radiotherapy and chemotherapy are administered, the patient will be evaluated for a potential watchful-waiting approach where, together with the patient, can be opted too not perform a TME (total mesorectal excision). This outcome measure registers if the therapy works.
次要结局
- Quality of life assessment via QLQ-C30(from the start of radiotherapy until 5 years after treatment)
- Colorectal specific quality of life assessment via QLQ-CR29(from the start of radiotherapy until 5 years after treatment)
- Bowel functioning specific quality of life assessment via LARS score(from the start of radiotherapy until 5 years after treatment)
- Anxiety and depression state via HADS(from the start of radiotherapy until 5 years after treatment)
研究者
Mark De Ridder
Principal Investigator, Prof.
Universitair Ziekenhuis Brussel