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| ID | Type | Description | Link |
|---|---|---|---|
| B670201628048 | Registry Identifier | Belgian Registration Number |
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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.
This is a phase II non-randomized trial, where 40 patients will be treated for breast cancer requiring whole breast irradiation as per standard of care. Patients will be simulated and treated using the novel prone crawl position to a total dose of 40.05 Gy in 15 fractions of 2.67 Gy.
The trial aims to evaluate setup precision, patient comfort and setup time in the prone crawl positioning. Feasibility of deep inspiration breathhold will be tested and dosimetric parameters evaluated.
This is done through registration of setup errors at the time of treatment, questionnaires for comfort/discomfort scoring, time registration, toxicity scoring, and dosimetric analysis in treatment planning systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prone crawl position | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prone crawl positioning | Device | Breast cancer patients are placed in a prone position with the ipsilateral arm besides the body rather than extended besides the head on a dedicated couch that provides the required support for maintaining this position. |
| Measure | Description | Time Frame |
|---|---|---|
| Setup error | Setup errors are analyzed using Van Herk parameters obtained by rigid coregistration of treatment imaging with simulation imaging | During the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient comfort | Patient comfort as assessed by questionnaire | immediately after the intervention |
| Setup Time | Time taken for setting up the patient for each fraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liv Veldeman, MD, PhD | University Hospital, Ghent | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33009448 | Result | Deseyne 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. | |
| 35115610 |
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Sharing patient data is not planned
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| During the intervention |
| Reproducibility of DIBH | The reproducibility and stability of deep inspiration breathhold is investigated by performing multiple breathhold manoevres during CT imaging at baseline, and comparing the relative geometric position of organs between on the acquired images for each patient. This will be evaluated by calculating the overlap index and dice similarity coefficien between these images. | At baseline |
| Acute toxicity | Acute side effects due to radiotherapy using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 toxicity scoring system, scoring toxicities from grade 0 (no toxicity) to grade 5 (death) | 6 months after treatment end |
| Dose to target and dose to organs at risk | Analysis is dose using the Dose-volume histogram (DVH) of targets and organs at risk, as obtained on CT simulation images. These DVH's are used to assess amount of radiation received by each organ and treatment target and assess the risk of treatment failure or treatment harm. | Before treatment initiation after CT simulation |
| Deseyne 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. |