High Dose Radiotherapy for the Treatment of Rectal Cancer

April 13, 2023 updated by: Yuan-hong Gao, Sun Yat-sen University

Efficacy and Toxicity of High Dose Radiotherapy Wich Concurrent Chemotherapy for the Treatment of Rectal Cancer

While surgery remains the standard treatment for rectal cancer, some patients still firmly refuse surgery for various reasons. Here, we conducted this retrospective observation study to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating rectal cancer We retrospectively collect data of rectal cancer patients who were treated with high-dose radiotherapy plus chemotherapy in Sun Yat-sen University Cancer Center from April 1st, 2006 to July 30th, 2017. Patients gave up surgery before any treatment would have received one course of high dose radiotherapy (GTV60-70Gy/30-35f). Patients with tumor residual after neoadjuvant chemoradiotherapy but insisted non-operative treatment would have received 2 courses of radiotherapy (1st: GTV 45-50Gy/25f, 2nd: GTV 30/15f). The chemotherapy regimens included Capox, FOLFOX, or capecitabine at the discretion of the treating physician.

After treatment, patients were followed every 3 months for the first two years, at least every 6 months in the year thereafter. Recurrence, early and late toxicity were recorded.

Analyses were performed using SPSS software, version 19.0 (SPSS, Chicago, IL). Local recurrence and distant metastasis rate, progression free survival, and overall survival were calculated using the Kaplan Meier Method and were compared by log-rank test.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

48

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This retrospective study included subjects identified from the database of the Sun Yat-sen University Cancer Center in the period of April 2006 to July 2017.

Description

Inclusion Criteria:

  1. pathologically confirmed diagnosis of rectal adenocarcinoma located within 15cm from the anal verge;
  2. pelvic radiation with a total dose ≥60Gy for the treatment of rectal cancer;
  3. refused surgery as the initial treatment;
  4. a complete set of clinical information and follow-up data.

Exclusion Criteria:

  1. patients with terminal cancer who received palliative treatment;
  2. patients received any treatment before admission to Sun Yat-sen University Cancer Center;
  3. patients with second primary cancer.

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-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical response rate
Time Frame: evaluate 5 weeks after radiotherapy
the rate of clinical response in the whole group
evaluate 5 weeks after radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
short term and long term side effects
Time Frame: from the complete to 3 years after treatment
short term and long term toxicity related to high dose radiotherapy
from the complete to 3 years after treatment
progression free survival
Time Frame: 3 years
defined as the time from the date of trial entry until disease progression, relapse, or death from any cause.
3 years
overall survival
Time Frame: 3 years
calculated from the date of trial entry until death from any cause or was censored at last follow-up
3 years

Collaborators and Investigators

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

Sponsor

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, 2017

Primary Completion (Actual)

March 16, 2019

Study Completion (Actual)

December 16, 2021

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria

May 18, 2018

First Posted (Actual)

May 30, 2018

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

  • 2018-FXY-079

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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