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

Not Applicable

Completed

• Conditions: Breast Cancer Female
• Interventions: Device: Prone crawl positioning

• Registration Number: NCT05179161
• Lead Sponsor: University Hospital, Ghent

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.

Study Timeline

• Study Start: 2016-05-31
• Primary Completion: 2016-09-29
• Study Completion: 2017-03-29
• Status Verified: 2021-10
• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Study First Posted: 2022-01-05
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prone crawl position	Prone crawl positioning	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)

Primary Outcome Measures

Name	Time	Method
Setup error	During the intervention	Setup errors are analyzed using Van Herk parameters obtained by rigid coregistration of treatment imaging with simulation imaging

Secondary Outcome Measures

Name	Time	Method
Setup Time	During the intervention	Time taken for setting up the patient for each fraction
Reproducibility of DIBH	At baseline	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.
Patient comfort	immediately after the intervention	Patient comfort as assessed by questionnaire
Acute toxicity	6 months after treatment end	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)
Dose to target and dose to organs at risk	Before treatment initiation after CT simulation	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.