Comparison of the Clinical Response of Total nEoadjuvant Treatment of Two Methods of Long-term or Short-term cHemoRadiotherapy Followed by Consolidation Chemotherapy in Patients With Locally Advanced rectAl Cancer (TEHRAN) , a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 114
- 主要终点
- Clinical complete response
研究概览
简要总结
Rectal cancer is one of the most prevalent malignancies in the world, and its prevalence is rising. In more advanced cases neoadjuvant therapy is advised before to surgery, and radiotherapy is one of its cornerstones. For the treatment of rectal cancer, there are primarily two radiation techniques. Long-term radiotherapy is 50.4 Gy delivered in 28 fractions, while short-term radiotherapy is 25 Gy delivered in 5 parts. In earlier studies, these two radiation techniques were combined with various chemotherapy drugs, and a relative comparison was established. Total neoadjuvant treatment, or TNT, has been linked to a better outcome because of the significance of organ preservation. The aim of this research is to compare two TNT radiation techniques with the same regimen of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced (T3-4, N+)adenocarcinoma of rectum that is located 5 to 15 cm from anal verge .
排除标准
- •Familial syndromes e.g. lynch Previous history of cancer Previous history of chemotherapy Recurrent disease Metastatic disease Inability to perform MRI (Claustrophobia or prosthetic valve)
结局指标
主要结局
Clinical complete response
时间窗: Week
At the 18th week following the start of the treatment, the patient will be assessed. The evaluation consist of an MRI and a colonoscopy, with a PET scan being optional.
次要结局
未报告次要终点
