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
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ClinicalTrials.gov Identifier: NCT00887523 |
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was: Recruiting
First Posted : April 24, 2009
Last Update Posted : June 3, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Carcinoma | Behavioral: radiation in prone position Behavioral: radiation in supine position | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | July 2009 |
Estimated Primary Completion Date : | December 2015 |
Estimated Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
prone intensity-modulated radiotherapy
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Behavioral: radiation in prone position
radiation in prone position |
Active Comparator: 2
supine intensity-modulated radiotherapy
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Behavioral: radiation in supine position
radiation in supine position |
- acute moist desquamation [ Time Frame: weekly during radiotherapy and 1 month after radiotherapy ]
- Acute skin toxicity other than moist desquamation [ Time Frame: weekly during radiotherapy and 1 month after radiotherapy ]
- Late skin toxicity [ Time Frame: 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 ]
- Quality of life [ Time Frame: at 1 year and 2 years after radiotherpay ]
- dose-volume parameters [ Time Frame: of planning ]
- time of treatment delivery [ Time Frame: daily during radiotherapy ]
- single nucleotide polymorphisms associated with skin toxicity and breast fibrosis [ Time Frame: 1 blood sample before radiotherapy ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887523
Contact: Liv Veldeman | liv.veldeman@uzgent.be |
Belgium | |
University Hospital Ghent | Recruiting |
Ghent, Belgium, 9000 | |
Contact: Wilfried De Neve, MD, PhD wilfried.deneve@uzgent.be |
Principal Investigator: | Wilfried De Neve, MD, PhD | University Hospital, Ghent |
Responsible Party: | University Hospital, Ghent |
ClinicalTrials.gov Identifier: | NCT00887523 |
Other Study ID Numbers: |
2009/184 |
First Posted: | April 24, 2009 Key Record Dates |
Last Update Posted: | June 3, 2015 |
Last Verified: | June 2015 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |