Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

February 13, 2023 updated by: Radoslaw Pach, MD, PhD, Jagiellonian University
The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with locally advanced rectal cancer operated on according to TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The treatment group comprises patients with locally advanced rectal cancer who were operated on in the 1st Department of General Surgery, Jagiellonian University, Cracow. The data on survival has been systematically collected using national census registry. Patients are qualified to preoperative radiotherapy 5x5 Gy and then randomly assigned to subgroups with different time interval between radiotherapy and surgery: one subgroup consists of patients operated on 7-10 days after the end of irradiation, the second subgroup consists of patients operated on after 4-5 weeks. Both should be homogenous in sex, age, cancer stage and localization, distal and circumferential resection margins, number of resected lymph nodes. 3D endorectal ultrasound and endorectal ultrasound with SonoVue are performed to assess the tumor before and after preoperative radiotherapy.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

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

  • Poland
    • Malopolska
      • Krakow, Malopolska, Poland, 31-501
        • First Department of Surgery

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • histologically confirmed rectal cancer
  • tumor localised in middle or lower rectum
  • age > 18 years
  • locally advanced cancer

Exclusion Criteria:

  • previous pelvis radiotherapy
  • lack of patient's consent
  • lack of possibility to begin radiotherapy during 14 days after inclusion to the study

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Short time interval
Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy.
Radiation: Preoperative radiotherapy
Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)
Other Names:
  • Neoadjuvant radiotherapy
Procedure: Surgery
Total mesorectal excision of rectal cancer
Other Names:
  • Operative treatment
Experimental: Long time interval
Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy.
Radiation: Preoperative radiotherapy
Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)
Other Names:
  • Neoadjuvant radiotherapy
Procedure: Surgery
Total mesorectal excision of rectal cancer
Other Names:
  • Operative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local and systemic recurrence rate
Time Frame: 5 years
Rate of local and sytemic recurrences in patients included to the protocol.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radical resections rate (R0)
Time Frame: 1 month
Rate of R0, R1 and R2 procedures according to Hermanek.
1 month
sphincter saving (sparing) procedures
Time Frame: 1 month
Rate of sphincter saving operations in both arms.
1 month
overall survival
Time Frame: 5 years
Overall survival and disease specific survival at 5 years follow-up
5 years
downstaging of rectal cancer
Time Frame: 1 month
Downstaging of the rectal cancer after preoprearite radiotherapy - assessed by comparison of preoperative ERUS, 3D ERUS, contrast enhanced ERUS and postoperative histologic staging
1 month

Collaborators and Investigators

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

Sponsor

Jagiellonian 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

January 1, 1999

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cracow Rectal Cancer Trial

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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