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Clinical Trials/NCT04745091
NCT04745091
Unknown
Not Applicable

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

Alexandria University0 sites20 target enrollmentFebruary 1, 2021
ConditionsRectum Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectum Cancer
Sponsor
Alexandria University
Enrollment
20
Primary Endpoint
Complete pathologic response
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
June 30, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Khaled Madbouly

Professor of Surgery

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • middle and low rectal cancer

Exclusion Criteria

  • Distant metastasis

Outcomes

Primary Outcomes

Complete pathologic response

Time Frame: after surgical excision with follow up of an average of 1 year

disappearance of tumor from resected specimen

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