Clinical trial · Interventional
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
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
NCT00887523CI-TRIAL-00062783completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation in prone position | Behavioral | — | UNRESOLVED |
| radiation in supine position | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- prone intensity-modulated radiotherapy
- interventionNames
- Behavioral: radiation in prone position
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- supine intensity-modulated radiotherapy
- interventionNames
- Behavioral: radiation in supine position
Primary outcomes (1)
- measure
- acute moist desquamation
- timeFrame
- weekly during radiotherapy and 1 month after radiotherapy
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDVakaet 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. PMID 33508375