Prone Breast Irradiation for Pendulous Breasts

Breast Cancer Clinical Trial

Official title:

Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181363
• Other study ID #: P03.1446L
• Status: Completed
• Phase: N/A
• Start date: December 2003
• Est. completion date: January 2007

Study information

• Verified date: January 2020
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Local excision followed by adjuvant radiotherapy has become standard treatment for women with early-stage breast cancer. Adjuvant radiotherapy may encounter technical difficulties in patients with pendulous breasts when treated in supine position.

Based upon literature and our own preliminary experiences, 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. However, no quantitative data are yet available to test this hypothesis. Therefore, the aim of our study is to compare the 3-D dose distribution in PTV and normal tissues in prone position versus supine position. For treatment in prone-position an in-house developed device, the "mammaboard" was used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2007
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Regional radiotherapy is indicated

• Unable to lie in prone position

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Mamma board
use of mamma board during radiotherapy

Locations

Country	Name	City	State
Netherlands	Maastricht Radiation Oncology	Heerlen	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Dose Homogeneity 3: V95 %	PTV coverage (% of PTV < 95% of prescribed dose) in prone position versus supine position	1 day after treatment planning
Secondary	PTV Coverage in Organs at Risk: MLD (Gy)	Doses in organs at risk: lung MLD (Mean Lung Dose)	during treatment planning
Secondary	PTV Coverage in Organs at Risk: Heart V30	Doses in organs at risk: heart V30: the volumes (%) of the heart that received >= 30Gy	during treatment planning