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
NCT ID: NCT00887523
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2009-07-31
2021-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
prone intensity-modulated radiotherapy
radiation in prone position
radiation in prone position
2
supine intensity-modulated radiotherapy
radiation in supine position
radiation in supine position
Interventions
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radiation in prone position
radiation in prone position
radiation in supine position
radiation in supine position
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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National Cancer Plan, France
UNKNOWN
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Wilfried De Neve, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital Ghent
Ghent, , Belgium
Countries
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References
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Vakaet V, Van Hulle H, Vergotte M, Schoepen M, Deseyne P, Van Greveling A, Post G, Speleers B, Paelinck L, Monten C, De Neve W, Veldeman L. 5-Year Outcomes of a Randomized Trial Comparing Prone and Supine Whole Breast Irradiation in Large-Breasted Women. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):766-771. doi: 10.1016/j.ijrobp.2021.01.026. Epub 2021 Jan 27.
Related Links
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website of the University Hospital Ghent
Other Identifiers
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2009/184
Identifier Type: -
Identifier Source: org_study_id