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

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ClinicalTrials.gov Identifier: NCT04745091
Recruitment Status : Not yet recruiting
First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Khaled Madbouly, Alexandria University

Study Description
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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

Condition or disease Intervention/treatment
Rectum Cancer Procedure: total mesorectal excision

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
Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Complete Clinical Response With MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Groups and Cohorts
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Intervention Details:
  • Procedure: total mesorectal excision
    excision of the rectum with complete excision of the mesorectum

Outcome Measures
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Primary Outcome Measures :
  1. Complete pathologic response [ Time Frame: after surgical excision with follow up of an average of 1 year ]
    disappearance of tumor from resected specimen


Biospecimen Retention:   Samples Without DNA
rectal cancer specimens

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
locally advance middle and low rectal cancer
Criteria

Inclusion Criteria:

middle and low rectal cancer

Exclusion Criteria:

  • Distant metastasis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745091


Contacts
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Contact: Khaled Madbouly, MD, PhD +2034802375 khaled.madbouly@alexmed.edu.eg

Sponsors and Collaborators
Alexandria University
Investigators
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Principal Investigator: Khaled Madbouly, MD, PhD University of Alexandria
More Information
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Responsible Party: Khaled Madbouly, Professor of Surgery, Alexandria University
ClinicalTrials.gov Identifier: NCT04745091    
Other Study ID Numbers: 0201372
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: no approval yet from ethical committee to share data. Not written in patients' consent yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases