NCT02237469

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
9.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

2.6 years

First QC Date

September 7, 2014

Last Update Submit

December 18, 2022

Conditions

Breast Cancer Female

Keywords

Breast cancerBreast conserving surgery.Radiotherapy.Treatment planning.Prone.

Outcome Measures

Primary Outcomes (1)

  • Radiation dose to heart and lungs

    Computations of doses and verification of physics charts.

    4 months

Secondary Outcomes (1)

  • Radiation dose to tumor bed and ipsilateral breast

    4 months

Other Outcomes (1)

  • Numbers of patients with dosimetry gain in prone position

    2 years

Study Arms (1)

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

Prone and supine simulationRADIATION

Treatment planning in the two positions.

Prone and supine simulation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Simulation in only one position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

Location

Related Publications (6)

  • 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.

    PMID: 27178144BACKGROUND

  • 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.

    PMID: 30322819BACKGROUND

  • 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.

    PMID: 32940569BACKGROUND

  • 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.

    PMID: 31757715BACKGROUND

  • 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.

    PMID: 33416915RESULT

  • 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.

    PMID: 35017568RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Vincent Vinh-Hung, MD, PhD

    University of Genova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 7, 2014

First Posted

September 11, 2014

Study Start

September 1, 2010

Primary Completion

April 1, 2013

Study Completion

December 1, 2023

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations

CH(1)