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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04745091
Enrollment
20
Registered
2021-02-09
Start date
2021-02-01
Completion date
2022-06-30
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectum Cancer

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

Interventions

PROCEDUREtotal mesorectal excision

excision of the rectum with complete excision of the mesorectum

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

middle and low rectal cancer

Exclusion criteria

* Distant metastasis

Design outcomes

Primary

MeasureTime frameDescription
Complete pathologic responseafter surgical excision with follow up of an average of 1 yeardisappearance of tumor from resected specimen

Contacts

Primary ContactKhaled Madbouly, MD, PhD
khaled.madbouly@alexmed.edu.eg+2034802375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026