MRI for Selection of Complete Responders After Chemoradiation for Locally Advanced Rectal Cancer

January 18, 2022 updated by: Ahmed Yehia Hefz Abd El.wanis, Assiut University

MRI for Response Evaluation After Chemoradiation for Locally Advanced Rectal Cancer

The purpose of our study is to evaluate the accuracy of MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The current standard of care for patients with T3 or T4 and/or node-positive rectal adenocarcinoma is to offer preoperative concomitant chemoradiotherapy(CRT) followed by total mesorectal excision (TME). 1 In 10-24% of patients, no residual tumor is found at histology after surgery.2 These complete responders are known to have a very good prognosis, in terms of overall and disease-free survival.2 A complete response also raises the hotly debated question of whether surgery is still necessary for these patients, especially because total mesorectal excision (TME) may have associated morbidity and even mortality and has the potential risk of a permanent colostomy.

Recently, a more conservative treatment is advocated in patients who show a good or complete response to neoadjuvant treatment. In 2006, Habr-Gama et al. Presented the long-term results of a prospective trial that investigated a "wait-and-see" policy in a carefully selected group of patients with clinical and radiological evidence of a complete response after neoadjuvant CRT. Results at 5-year follow-up were favorable for the nonsurgical group, with an overall and disease-free survival of 93% and 85%, respectively 3.

Recently, A watch and wait policy avoids the morbidity associated with radical surgery and preserves oncologic outcomes. It could be considered a therapeutic option in patients with locally advanced rectal cancer following chemoradiotherapy with a complete clinical response.4 To safely omit surgery, it is essential to select accurately the right candidates, i.e., the true complete responders. This selection is mainly performed using digital examination, endoscopy, and biopsy, but these methods are not infallible.

High-resolution magnetic resonance imaging (MRI) has been used to assess tumor response before surgical resection. By applying the principals of histopathologic TRG and by exploiting the characteristic MRI low-signal-intensity appearances of fibrosis, it has been possible to develop a similar MRI-based TRG system. The MRI-assessed TRG (mrTRG) was found to be an independent prognostic factor for overall survival (OS) and DFS.5 Complete pathologic response (pCR) after CRT has led to the proposal of a nonoperative approach as an alternate treatment for highly selected patients with a complete clinical response (CR). Habr-Gama et al reported findings from 99 patients with a clinical CR who were treated with observation alone. The 5-year OS and DFS rates were 93% and 85%, respectively.6 In a recent study, MRI-assessed complete tumor response was strongly correlated with pathologic complete response and, therefore, can be used as a surrogate marker to predict absence of viable tumor cells.7 Recently, Diffusion-weighted MRI (DWI) could be useful for response evaluation after chemoradiation treatment (8-10) In 2009, Kim et al. showed in a study of 40 patients that DWI in addition to standard MRI significantly improved the performance of radiologists to select complete responders compared with standard MRI only

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohamed Elbaroudy, Lecturer
  • Phone Number: +20106220029

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assuit university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

18 years old with locally advanced rectal adenocarcinoma (T3c-T4 N any, CRM+ M0) treated with neoadjuvant chemoradiotherapy

Description

Inclusion Criteria:

  • Patients >18 years old with locally advanced rectal adenocarcinoma (T3c-T4 N any, CRM+ M0) treated with neoadjuvant chemoradiotherapy

    • Baseline and post treatment MRI scans required for each patient;
    • Clinical assessment including digital rectal examination, and endoscopy are needed for each patient

Exclusion Criteria:

  • - Patient who is not fit for preoperative CRT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI for selection of chemoradiation response evaluation for cancer rectum
Time Frame: Baseline

The purpose of our study is to evaluate the accuracy of MRI for response evaluation

after chemoradiation for locally advanced rectal cancer . Primary outcome includes Tumor site, size, volume, extension, T2, DWI signal intensity.

Secondary outcome after chemo-radiotherapy in T2, DWI signal intensity changes
Baseline
Secondary outcome after chemo-radiotherapy
Time Frame: 2 months
in T2, DWI signal intensity changes T2, DWI signal intensity changes
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Shymaa Abdallah, Lecturer, Assiut University
  • Study Chair: Hossam Eldin Galal, Proffesor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRI Rectum

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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