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临床试验/NCT04814784
NCT04814784Unknown不适用

Retrospective Study Comparing Neoadjuvent Short Course of Radiotherapy to Conventional Chemoradiation in Cancer Rectum

Amany sayed Abass1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年3月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
48
试验地点
1
主要终点
Effect of neoadjuvent radiotherapy in treatment of locally advanced cancer rectum

研究概览

简要总结

This is a retrospective study comparing neoadjuvent short course radiotherapy to conventional chemoradiation in locally advanced cancer rectum and the effect of both regimens in overall survival and disease free survival

详细描述

Colorectal cancer is the third most common cancer diagnosed in the western world. In 2019 there were approximately 44180 new cases of rectal cancer diagnosed in the United states.

Due to the close proximity of the rectum to pelvic structures and organs, the absence of a serious membrane surrounding the rectum and the restriction of the surgical view and access by the pelvic cavity, the locoregional recurrence rate in rectal cancer is relatively high after surgery alone.

Neoadjuvent therapy rather than surgery followed by adjuvent therap has been the preferred approach world wide in treatment of rectal cancer since the 2004 publication of the seminal German CAO/ARO/AIO-94 study ,which compared preoperative with postoperative chemoradiation in 823 patients The use of neoadjuvent therapy is recommended for all newly diagnosed rectal adenocarcinoma with a clinical stage T3 or T4 based on trans rectal endoscopic ultrasound or pelvic MRI .Neoadjuvent therapy may comprise of either radiotherapy alone or in combination with chemotherapy, commonly prescribed chemotherapy agents include 5-fluorouracil and Oxaloplatin.

Both short course radiotherapy (25 Gy in 5 fractions) and long course radiotherapy (50.4Gy in 28 fractions, conventionally fractionated therapy)can be applied as neoadjuvent radiotherapy.

Several phase lll RCTs,including three large well-designed international RCTs have reported that short course neoadjuvent radiation treatment improves local control compared with surgery alone in patients with respectable rectal cancer.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • histologically proved adenocarcinoma of the rectum
  • Age between 18 and 70 yrs
  • T3 and T4 N1,N2 respectable tumor
  • The WHO performance score 0-2
  • have a free metastatic work up excluded by chest x-ray , abdominal ultrasonography or CT pelviabdomen

排除标准

  • patients with locally advanced inoperable disease locally recurrent rectal cancer
  • had a history of malignant tumor within 5 years except the skin cancer
  • pregnant or lactating women
  • previous irradiation in pelvis
  • there was contraindication for neoadjuvent radiotherapy or surgery
  • known metastatic disease
  • mental disorder

结局指标

主要结局

Effect of neoadjuvent radiotherapy in treatment of locally advanced cancer rectum

时间窗: 4 years

Disease free survival.

次要结局

未报告次要终点

研究者

发起方
Amany sayed Abass
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amany sayed Abass

Physician Dr

Assiut University

研究点 (1)

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