Breast Cancer Female Clinical Trial
Official title:
Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery
Verified date | October 2021 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 29, 2017 |
Est. primary completion date | September 29, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University Hospital, Ghent |
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 br — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Setup error | Setup errors are analyzed using Van Herk parameters obtained by rigid coregistration of treatment imaging with simulation imaging | During the intervention | |
Secondary | Patient comfort | Patient comfort as assessed by questionnaire | immediately after the intervention | |
Secondary | Setup Time | Time taken for setting up the patient for each fraction | During the intervention | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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