Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis

December 15, 2022 updated by: University Hospital, Ghent

Randomized Controlled Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis

84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female patients
  • multidisciplinary decision of adjuvant whole-breast irradiation (WBI) after lumpectomy for breast cancer
  • minimum 18 years
  • informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

  • mastectomy
  • need for axillary irradiation
  • bilateral breast irradiation
  • previous irradiation at the same time
  • mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
  • patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete 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
Experimental: 1
prone intensity-modulated radiotherapy
Behavioral: radiation in prone position
radiation in prone position
Active Comparator: 2
supine intensity-modulated radiotherapy
Behavioral: radiation in supine position
radiation in supine position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
acute moist desquamation
Time Frame: weekly during radiotherapy and 1 month after radiotherapy
weekly during radiotherapy and 1 month after radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute skin toxicity other than moist desquamation
Time Frame: weekly during radiotherapy and 1 month after radiotherapy
weekly during radiotherapy and 1 month after radiotherapy
Late skin toxicity
Time Frame: at 6, 12, 18 and 24 months after radiotherapy
at 6, 12, 18 and 24 months after radiotherapy
skin and lung fibrosis assessed with computed tomography
Time Frame: before radiotherapy and 1 month and 1 year after radiotherapy
before radiotherapy and 1 month and 1 year after radiotherapy
Quality of life
Time Frame: at 1 year and 2 years after radiotherpay
at 1 year and 2 years after radiotherpay
dose-volume parameters
Time Frame: of planning
of planning
time of treatment delivery
Time Frame: daily during radiotherapy
daily during radiotherapy
single nucleotide polymorphisms associated with skin toxicity and breast fibrosis
Time Frame: 1 blood sample before radiotherapy
1 blood sample before radiotherapy

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Collaborators

National Cancer Plan, France

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

Helpful Links

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)

July 1, 2009

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

March 8, 2021

Study Registration Dates

First Submitted

April 23, 2009

First Submitted That Met QC Criteria

April 23, 2009

First Posted (Estimate)

April 24, 2009

Study Record Updates

Last Update Posted (Estimate)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/184

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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