Clinical trial NCT05179161: Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery
Official title: Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: Prone positioning
Prone crawl position
Radiotherapy
Whole breast irradiation
Setup errors
Patient comfort
Setup time
Deep inspiration breathhold
Dosimetry
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Setup error
timeFrame: During the intervention
Secondary outcomes:
measure: Patient comfort
timeFrame: immediately after the intervention
measure: Setup Time
timeFrame: During the intervention
measure: Reproducibility of DIBH
timeFrame: At baseline
measure: Acute toxicity
timeFrame: 6 months after treatment end
measure: Dose to target and dose to organs at risk
timeFrame: Before treatment initiation after CT simulation
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Ghent
name: Liv Veldeman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.