Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Device: Prone crawl positioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prone crawl position<br>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) | Device: Prone crawl positioning<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prone positioning, Prone crawl position, Radiotherapy, Whole breast irradiation, Setup errors, Patient comfort, Setup time, Deep inspiration breathhold, Dosimetry