Clinical trial · Interventional
Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery
NCT05179161CI-TRIAL-00055796completedN/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)
The aim of this study is to validate the obtained results of setup precision, comfort and setup time. The possibility of using breath hold for heart sparing in combination with prone crawl position will be tested. Forty patients (20 with left-sided and 20 with right-sided breast carcinoma) presenting for WBI without LNI after breast-conserving surgery will be included after signing informed consent.
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 Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prone crawl positioning | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prone crawl position
- description
- Patients are placed in the prone crawl position for whole breast irradiation and are treated with 15 x 2,67 Gy (± boost treatment if required as per international guidelines)
- interventionNames
- Device: Prone crawl positioning
Primary outcomes (1)
- measure
- Setup error
- timeFrame
- During the intervention
- description
- Setup errors are analyzed using Van Herk parameters obtained by rigid coregistration of treatment imaging with simulation imaging
Secondary outcomes (5)
- measure
- Patient comfort
- timeFrame
- immediately after the intervention
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients * Non-metastasized breast carcinoma * Multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer * Prone WBI without LNI indicated according to the department's guidelines, treatment schedule of at least 15 fractions * Age ≥ 18 years * Informed consent obtained, signed and dated before specific protocol procedures Exclusion Criteria: * \< 18 years old * Mastectomy * Need for LNI * Bilateral breast irradiation * Partial breast irradiation * Unable to be treated in prone position * Less than 15 treatment fractions planned * Situs inversus * Pregnant or breastfeeding * 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 (2)
- RESULTDeseyne P, Speleers B, De Neve W, Boute B, Paelinck L, Vakaet V, Van Hulle H, Schoepen M, Stouthandel M, Van Greveling A, Post G, Detand J, Monten C, Depypere H, Veldeman L. Crawl positioning improves set-up precision and patient comfort in prone whole breast irradiation. Sci Rep. 2020 Oct 2;10(1):16376. doi: 10.1038/s41598-020-72702-3. PMID 33009448
- DERIVEDDeseyne P, Speleers B, Paelinck L, De Gersem W, De Neve W, Schoepen M, Van Greveling A, Van Hulle H, Vakaet V, Post G, Monten C, Depypere H, Veldeman L. Reproducibility of repeated breathhold and impact of breathhold failure in whole breast and regional nodal irradiation in prone crawl position. Sci Rep. 2022 Feb 3;12(1):1887. doi: 10.1038/s41598-022-05957-7. PMID 35115610