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临床试验/NCT04745091
NCT04745091Unknown不适用

Complete Clinical Response With MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer

Alexandria University0 个研究点目标入组 20 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Complete pathologic response

研究概览

简要总结

Patients with middle or low rectal cancer who receive neoadjuvant chemoradiation and achieve complete clinical response while their pelvic MRI have split scar sign are included. Patients will have total mesorectal excision and pathologic complete response will be assessed

详细描述

Patients with middle or low rectal cancer who have T3-4 and/ or N+ will be included. Patients will receive neoadjuvant chemoradiation in the form of pelvic irradiation by 50.4 thousands grays together with radio sensitization by 5-FU or oxaliplatin, 8 months after completion of neoadjuvant chemoradiation patients will be assessed clinically and radiologically. Complete clinical response is diagnosed if clinically no tumor is felt or just small scar and no tumor appears in MRI. Of these patients who achieve complete clinical response we will pick up cases who have split scar sign in the pelvic MRI. Patients will have total mesorectal excision 8-11 weeks after completion of neoadjuvant chemoradiation and pathologic complete response will be assessed. Correlation will be done between preoperative clinical response and postoperative pathologic response

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • middle and low rectal cancer

排除标准

  • Distant metastasis

结局指标

主要结局

Complete pathologic response

时间窗: after surgical excision with follow up of an average of 1 year

disappearance of tumor from resected specimen

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Madbouly

Professor of Surgery

Alexandria University

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