NCT00181363

Brief Summary

We hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the PTV, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart.The purpose of this study is to compare the 3-D dose distribution in PTV(Planning Target Volume) and normal tissues in prone position versus supine position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2003

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
13.1 years until next milestone

Results Posted

Study results publicly available

January 28, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

September 9, 2005

Results QC Date

April 12, 2011

Last Update Submit

January 15, 2020

Conditions

Breast Cancer

Keywords

Breast cancerBreast conserving surgeryRadiotherapyPendulous breasts

Outcome Measures

Primary Outcomes (3)

  • Dose Homogeneity 1: PTV

    Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position

    1 day after treatment planning

  • Dose Homogeneity 2: V105% and V107%

    Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) in prone position versus supine position

    1 day after treatment planning

  • Dose Homogeneity 3: V95 %

    PTV coverage (% of PTV \< 95% of prescribed dose) in prone position versus supine position

    1 day after treatment planning

Secondary Outcomes (2)

  • PTV Coverage in Organs at Risk: MLD (Gy)

    during treatment planning

  • PTV Coverage in Organs at Risk: Heart V30

    during treatment planning

Study Arms (1)

Mamma board

EXPERIMENTAL

use of the mamma board during radiotherapy

Device: Mamma board

Interventions

Mamma boardDEVICE

use of mamma board during radiotherapy

Also known as: radiation, prone breast, mammaboard
Mamma board

Eligibility Criteria

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

You may qualify if:

  • Patients should have had breast-conserving surgery for breast cancer or DCIS (Ductal Carcinoma in Situ)
  • No indication for radiotherapy of regional nodes
  • Large, pendulous breasts (bra size D and over)

You may not qualify if:

  • Regional radiotherapy is indicated
  • Unable to lie in prone position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht Radiation Oncology

Heerlen, Limburg, 6419 PC, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
J. Buijsen,
Organization
Maastro Radiation Oncology
jeroen.buijsen@maastro.nl
+31 (0)88-44-55-666

Study Officials

  • Jeroen Buijsen, MD

    Maastricht Radiation Oncology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

December 1, 2003

Primary Completion

July 1, 2006

Study Completion

January 1, 2007

Last Updated

January 28, 2020

Results First Posted

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)