Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer

April 19, 2019 updated by: Sung-Bum Kang, Seoul National University Hospital

Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer: a Multicenter Comparative Study With Rectal Preservation as Supported by Surgeon

Though refusal of radical surgery was often happened in rectal cancer patient after neoadjuvant chemoradiotherapy, little is currently known about the actual oncologic outcome of it. Thus the investigators designed this study to compare the oncologic outcome of unintended rectal preservation with intended rectal preservation by surgeon.

Study Overview

Status

Completed

Conditions

Detailed Description

The investigators identified patients whose organ were preserved by non-operative management or local excision after neoadjuvant chemoradiotherapy for mid to low rectal cancer. Then, the patients were categorized into two groups according to the agreement on omitting radical surgery (rectal preservation). When treatment decision was agreed by their surgeon, the patients were categorized as intended rectal preservation. When there was disagreement by surgeon on rectal preservation, then the patients categorized as unintended rectal preservation. Oncologic outcome was compared between two groups.

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
    • GyeongGi
      • SeongNam, GyeongGi, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of
        • National Cancer Center, Korea

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intended organ preservation

  • non-operative management or local excision selected by surgeon

Unintended organ preservation

  • non-operative management or local excision persisted by patient and disagreed by surgeon

Description

Inclusion Criteria:

  • biopsy proven rectal cancer (anal verge ≤ 10cm)
  • neoadjuvant radiotherapy or chemoradiotherapy
  • no radical surgery after neoadjuvant therapy

Exclusion Criteria:

  • other malignant disease
  • other fatel disease
  • incompletion of half of radiotherapy course
  • metastasis on initial presentation

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: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intended rectal preservation
When rectal preservation (non-operative management or local excision) was agreed by their surgeon.
Unintended rectal preservation
When rectal preservation (non-operative management or local excision) was disagreed by their surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year overall survival
Time Frame: from date of completion of chemoradiotherapy until the date of death from any cause, whichever came first, assessed at 31th December 2017 by checking expire date of a resident registration number
Overall survival rate at 3-year after completion of chemoradiotherapy
from date of completion of chemoradiotherapy until the date of death from any cause, whichever came first, assessed at 31th December 2017 by checking expire date of a resident registration number

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

National Cancer Center, Korea
Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Jae-Hwan Oh, Ph.D., National Cancer Center, Korea
  • Principal Investigator: Kyu Joo Park, Ph.D., Seoul National University Hospital

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 (Actual)

May 1, 2016

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (Actual)

April 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1711/433-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The row data generated during and/or analysed during the current study couldn't be shared to public or other researcher because of institutional policy.

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.

Clinical Trials on Chemoradiation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe