Prone Breast Radiotherapy Treatment Planning Observational Study (HUGProne)

Retrospective Dosimetric Study of Prone Radiotherapy for Breast Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Radiation: Prone and supine simulation

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.

• Study Type: Observational
• Enrollment (Anticipated): 280

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Geneva University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Simulation in only one position

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Treatment planning in the two positions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation dose to heart and lungs	Computations of doses and verification of physics charts.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation dose to tumor bed and ipsilateral breast	Computations of doses and verification of physics charts.	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Vincent Vinh-Hung
• Collaborators: Varian Medical Systems
• Investigators: Principal Investigator: Vincent Vinh-Hung, MD, PhD, University of Genova

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 7, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 18, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Breast cancer; Breast conserving surgery.; Radiotherapy.; Treatment planning.; Prone.
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HUG 13-184R