Prone Breast Radiotherapy Treatment Planning Observational Study

Breast Cancer Female Clinical Trial

— HUGProne  

Official title:

Retrospective Dosimetric Study of Prone Radiotherapy for Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02237469
• Other study ID #: HUG 13-184R
• Status: Active, not recruiting
• Start date: September 2010
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: December 2023
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Breast conserving surgery

• Adjuvant radiation treatment

• Simulation done prone and supine

Exclusion Criteria:

• Simulation in only one position

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Radiation:
• Prone and supine simulation
Treatment planning in the two positions.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Vincent Vinh-Hung	Varian Medical Systems

Country where clinical trial is conducted

Switzerland, 

References & Publications (6)

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. — View Citation

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. — View Citation

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- — View Citation

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. — View Citation

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. — View Citation

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. Strahlent — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Radiation dose to heart and lungs	Computations of doses and verification of physics charts.	4 months
Secondary	Radiation dose to tumor bed and ipsilateral breast	Computations of doses and verification of physics charts.	4 months