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

NCT05179161 | Completed

• 2 other identifiers: EC-UZ-2016/0351B670201628048
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer Female

Keywords

Prone positioning; Prone crawl position; Radiotherapy; Whole breast irradiation; Setup errors; Patient comfort; Setup time; Deep inspiration breathhold; Dosimetry

Outcome Measures

Primary Outcomes (1)

• Setup error

  Setup errors are analyzed using Van Herk parameters obtained by rigid coregistration of treatment imaging with simulation imaging

  During the intervention

Secondary Outcomes (5)

• Patient comfort

  immediately after the intervention

• Setup Time

  During the intervention

• Reproducibility of DIBH

  At baseline

• Acute toxicity

  6 months after treatment end

• Dose to target and dose to organs at risk

  Before treatment initiation after CT simulation

Study Arms (1)

Prone crawl position

EXPERIMENTAL

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

Interventions

Prone crawl positioning DEVICE

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.

Prone crawl position

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Related Publications (2)

• 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.

  PMID: 33009448 RESULT

• 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.

  PMID: 35115610 DERIVED

Study Officials

• Liv Veldeman, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: January 5, 2022
• Study Start: May 31, 2016
• Primary Completion: September 29, 2016
• Study Completion: March 29, 2017
• Last Updated: January 5, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share