NCT01582750Unknown不适用
Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values
研究概览
简要总结
The purpose of this study is to determine the role of endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values in predicting the tumor regression after concurrent chemoradiotherapy for rectal cancer.
详细描述
We use endoscopic ultrasound to measure the primary tumor maximum diameter changes to predict the tumor regression after concurrent chemoradiotherapy for rectal cancer
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically confirmed rectal cancer, preoperative stage II / III (T3-4N0 or T1-4N + M0).
- •tumor distance from anus less than 12 cm.
- •KPS score not less than 70
- •can be tolerated chemotherapy and radiotherapy.
- •pelvic who had no history of radiation therapy.
- •Non-allergic history of fluorouracil or platinum-based chemotherapy drugs.
- •a full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent.
排除标准
- •other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous).
- •pregnant or lactating patients.
- •fertility but did not use contraceptive measures.
- •existing active infection.
- •merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension.
- •concurrent treatment with other anticancer drugs.
- •can not complete treatment or follow-up.
结局指标
主要结局
Endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values
时间窗: 3 months
次要结局
未报告次要终点
研究者
Jing Jin, M.D.
Director of Abdomen Division, Radiation Oncology Department
Chinese Academy of Medical Sciences
研究点 (1)
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