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NCT04745091 Clinical Trial

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

Rectum Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04745091
Other study ID # 0201372
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date June 30, 2022

Study information
Verified date January 2021
Source Alexandria University
Contact Khaled Madbouly, MD, PhD
Phone +2034802375
Email khaled.madbouly@alexmed.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date June 30, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: middle and low rectal cancer Exclusion Criteria: - Distant metastasis

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• total mesorectal excision
excision of the rectum with complete excision of the mesorectum

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alexandria University

Outcome
Type Measure Description Time frame Safety issue
Primary Complete pathologic response disappearance of tumor from resected specimen after surgical excision with follow up of an average of 1 year
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