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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05179161
• Other study ID #: EC-UZ-2016/0351
• Secondary ID: B670201628048
• Status: Completed
• Phase: N/A
• Start date: May 31, 2016
• Est. completion date: March 29, 2017

Study information

• Verified date: October 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer Female

Intervention

Device:
• Prone crawl positioning
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

References & Publications (1)

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

Outcome

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