Outcomes of Neoadjuvant Therapy for Rectal Cancer in a Tertiary Asian Institute

October 31, 2022 updated by: Singapore General Hospital

Outcomes of Neoadjuvant Therapy for Rectal Cancer in a Tertiary Asian

This is a retrospective cohort study that aims to evaluate the correlation of magnetic resonance tumour regression grade (mrTRG) and pathological TRG (pTRG) of locally advanced rectal cancer after neoadjuvant long course chemoradiotherapy as well as the prognostic value of mrTRG on survival.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

59

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with locally advanced rectal cancer were recruited from the Department of Colorectal Surgery, Singapore General Hospital

Description

Inclusion Criteria:

  • Rectal cancer
  • At least 1 high risk feature on MRI
  • Undergo long course neoadjuvant chemoradiotherapy (LCCRT)

Exclusion Criteria:

  • metastatic disease
  • Patients who undergo short course radiotherapy
  • Patients without a repeat MRI after completion of LCCRT

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: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between mrTRG and pTRG
Time Frame: Between 1 Jan 2011 to 31 Dec 2016
Between 1 Jan 2011 to 31 Dec 2016

Secondary Outcome Measures

Outcome Measure
Time Frame
Prognostic value of mrTRG on survival outcomes of rectal cancer patients
Time Frame: Between 1 Jan 2011 to 31 Dec 2016
Between 1 Jan 2011 to 31 Dec 2016

Collaborators and Investigators

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

Sponsor

Singapore General Hospital

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 (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/2342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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