NCT01379612已完成不适用
Ultrasound Elastography of Rectal Cancer Patients Treated With Preoperative Chemoradiation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Tumor regression grade
研究概览
简要总结
The aim of this study is to recruit 50 rectal cancer patients planned to receive standard radiochemotherapy. A baseline ultrasonic elastography is performed prior to radiochemotherapy and followed by re-scans two and six weeks after initiation of treatment. The objective quantitative elastography findings are compared with the TRG score.
The purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after operation.
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
- •Patients with biopsy verified adenocarcinoma in the rectum ≤ 10 cm from the anal verge.
- •T3/4 tumor assessed by transrectal ultrasound and MR, and CRMMR < 5 mm.
- •Life expectancy of more than 3 months.
- •Age ≥18 years.
- •Performance status ≤ 2 according to WHO.
- •Patient able to observe protocol guidelines.
- •Signed informed consent.
排除标准
- •Previous radiation treatment for the pelvis.
- •Known distant metastases.
- •Serious disease contraindicating treatment, including cardiovascular disease.
- •Other malignant disease apart from curativly treated non-melanotic skin cancer and previously treated carcinoma in situ cervicis uteri.
- •other disease making the patient unfit for study participation as assessed by investigator
结局指标
主要结局
Tumor regression grade
时间窗: 8 weeks after operation
次要结局
未报告次要终点
研究者
研究点 (2)
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