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Completed

NCT Number: NCT05179161

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

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.

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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Setup error

    Time frame: During the intervention

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

Secondary outcomes

  1. Patient comfort

    Time frame: immediately after the intervention

    Patient comfort as assessed by questionnaire

  2. Setup Time

    Time frame: During the intervention

    Time taken for setting up the patient for each fraction

  3. Reproducibility of DIBH

    Time frame: 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.

  4. Acute toxicity

    Time frame: 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)

  5. Dose to target and dose to organs at risk

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 5, 2022
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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