CClinicalTrials.gg
Status unknownNCT02237469HUGProneUpdated Dec 21, 2022

Prone Breast Radiotherapy Treatment Planning Observational Study

An observational study in Breast Cancer Female, sponsored by Vincent Vinh-Hung. Status unknown at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-21.

Sponsored by Vincent Vinh-Hung · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
280
Ages
18 Years and older
Sex
Female
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Study summary

The study purpose is to evaluate whether or not clinical characteristics of women with breast cancer can predict which position for radiation treatment, prone or supine, will be associated with a dosimetry gain. Dosimetry gain in this study means the lowest radiation dose to non-target organs (heart, lungs, contralateral breast), while giving the prescribed dose to tumor bed and ipsilateral breast.

Read the detailed description

Retrospectively identify women who received curative radiation treatment after breast conserving cancer surgery, in whom simulation in prone and in supine position was performed. Compare the treatment plans for doses to targets and to non-target organs, according to clinical parameters of body mass index, size of breast, location of tumor and side. Furthermore, evaluate whether a single CT slide is enough or not to predict a dosimetry advantage.

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Conditions studied

  • Breast Cancer Female

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Keywords

  • Breast cancer
  • Breast conserving surgery.
  • Radiotherapy.
  • Treatment planning.
  • Prone.
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 280 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with Vincent Vinh-Hung as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive patients addressed for adjuvant radiation treatment after breast conserving surgery for breast cancer, in whom simulation was done prone and supine.

Inclusion criteria

  • Breast conserving surgery
  • Adjuvant radiation treatment
  • Simulation done prone and supine

Exclusion criteria

Exclusion Criteria:

  • Simulation in only one position
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
280 participants (estimated)
Patient registry
No

Groups and cohorts

  • Prone and supine simulation

    Women with breast cancer receiving simulation in prone and in supine position for adjuvant radiation treatment.

    Radiation: Prone and supine simulation

Interventions

  • RadiationProne and supine simulation

    Treatment planning in the two positions.

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What researchers measure

Primary outcomes

  1. Radiation dose to heart and lungs

    Computations of doses and verification of physics charts.

    Time frame: 4 months

Secondary outcomes

  1. Radiation dose to tumor bed and ipsilateral breast

    Computations of doses and verification of physics charts.

    Time frame: 4 months

Other outcomes

  1. Numbers of patients with dosimetry gain in prone position

    Evaluate the dosimetry gain in subgroups classified according to body mass index, size of breast, side and location of tumor.

    Time frame: 2 years

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Study locations

1 site
  • Geneva University Hospitals
    Geneva, 1205, Switzerland
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References and documents

Publications

  • Dipasquale G, Wang X, Chatelain-Fontanella V, Vinh-Hung V, Miralbell R. Automatic segmentation of breast in prone position: Correlation of similarity indexes and breast pendulousness with dose/volume parameters. Radiother Oncol. 2016 Jul;120(1):124-7. doi: 10.1016/j.radonc.2016.04.041. Epub 2016 May 10. PubMed 27178144 ↗
  • Andrianarison VA, Laouiti M, Fargier-Bochaton O, Dipasquale G, Wang X, Nguyen NP, Miralbell R, Vinh-Hung V. Contouring workload in adjuvant breast cancer radiotherapy. Cancer Radiother. 2018 Dec;22(8):747-753. doi: 10.1016/j.canrad.2018.01.008. Epub 2018 Oct 12. PubMed 30322819 ↗
  • Heymann S, Dipasquale G, Nguyen NP, San M, Gorobets O, Leduc N, Verellen D, Storme G, Van Parijs H, De Ridder M, Vinh-Hung V. Two-Level Factorial Pre-TomoBreast Pilot Study of Tomotherapy and Conventional Radiotherapy in Breast Cancer: Post Hoc Utility of a Mean Absolute Dose Deviation Penalty Score. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820947759. doi: 10.1177/1533033820947759. PubMed 32940569 ↗
  • Vinh-Hung V, Leduc N, Verellen D, Verschraegen C, Dipasquale G, Nguyen NP. The mean absolute dose deviation-A common metric for the evaluation of dose-volume histograms in radiation therapy. Med Dosim. 2020 Summer;45(2):186-189. doi: 10.1016/j.meddos.2019.10.004. Epub 2019 Nov 19. PubMed 31757715 ↗
  • Wang X, Fargier-Bochaton O, Dipasquale G, Laouiti M, Kountouri M, Gorobets O, Nguyen NP, Miralbell R, Vinh-Hung V. Is prone free breathing better than supine deep inspiration breath-hold for left whole-breast radiotherapy? A dosimetric analysis. Strahlenther Onkol. 2021 Apr;197(4):317-331. doi: 10.1007/s00066-020-01731-8. Epub 2021 Jan 8. PubMed 33416915 ↗
  • Fargier-Bochaton O, Wang X, Dipasquale G, Laouiti M, Kountouri M, Gorobets O, Nguyen NP, Miralbell R, Vinh-Hung V. Prone versus supine free-breathing for right-sided whole breast radiotherapy. Sci Rep. 2022 Jan 11;12(1):525. doi: 10.1038/s41598-021-04385-3. PubMed 35017568 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02237469
Lead sponsor
Vincent Vinh-Hung
Collaborators
Varian Medical Systems
Responsible party
Vincent Vinh-Hung (MD, PhD, University Hospital, Geneva) — Sponsor-investigator
First posted
Sep 11, 2014
Start date
Sep 2010
Primary completion
Apr 2013
Completion
Dec 2023 (estimated)
Last update
Dec 21, 2022

Study contacts

Vincent Vinh-Hung, MD, PhD
principal investigator · University of Genova

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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