Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response

April 13, 2023 updated by: Yuan-hong Gao

Watch-and-wait Approach Versus Surgical Resection for Rectal Cancer Patients With Complete Clinical Response After Chemoradiotherapy: a Multi-center Cohort Study

This was a propensity-score matched observational analysis, comparing the oncological outcome of surgical resection vs watch and wait apporach for rectal cancer patients with a cCR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response from the year 2010 to 2018 were included. Sequential subjects were identified from a prospective maintained database in the Sun Yat-sen University Cancer Center. Clinical experts on rectal cancer from other 5 regional medical centers in China were also invited to participate, and provided data of cCR patients. Standardized forms for data collection were sanded to researchers in each center. Patients received radical resection will constituted our surgery group. Those refused surgery constituted the observation group who went on with the watch and wait approach. A propensity-score matched observational analysis will be used to compare the oncological outcome of these two groups.

Study Type

Observational

Enrollment (Actual)

513

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center

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

16 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response were included and divided into two groups according to the treatment followed.

Description

Inclusion Criteria:

  • Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response

Exclusion Criteria:

  • history of a second primary malignancy.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
observation group
Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response, and refused surgery but went on with the watch and wait approach.
surgery group
Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response, and received radical resection.
Procedure: standard TME surgery
radical resection for rectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: the time from the date of treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
progression-free survival
the time from the date of treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: Overall survival was calculated from the date of first treatment until death from any cause or was censored at last follow-up, assessed up to 60 months
overall survival
Overall survival was calculated from the date of first treatment until death from any cause or was censored at last follow-up, assessed up to 60 months

Collaborators and Investigators

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

Sponsor

Yuan-hong Gao

Collaborators

Fujian Cancer Hospital
Tongji Hospital
Peking University Cancer Hospital & Institute
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sixth Affiliated Hospital, Sun Yat-sen University
Fujian Medical University Union Hospital

Investigators

  • Principal Investigator: Yuan-hong Gao, MD, Sun Yat-sen University

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, 2018

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2018-174-01

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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