Prone Breast Irradiation for Pendulous Breasts

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Mamma board

• Registration Number: NCT00181363
• Lead Sponsor: Maastricht Radiation Oncology

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.

Detailed 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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-16
• Primary Completion: 2006-07
• Study Completion: 2007-01
• Results First Submitted: 2011-04-12
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-15
• Last Update Submitted: 2020-01-15
• Results First Posted: 2020-01-28
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mamma board	Mamma board	use of the mamma board during radiotherapy

Primary Outcome Measures

Name	Time	Method
Dose Homogeneity 1: PTV	1 day after treatment planning	Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position
Dose Homogeneity 3: V95 %	1 day after treatment planning	PTV coverage (% of PTV \< 95% of prescribed dose) in prone position versus supine position
Dose Homogeneity 2: V105% and V107%	1 day after treatment planning	Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) in prone position versus supine position

Secondary Outcome Measures

Name	Time	Method
PTV Coverage in Organs at Risk: Heart V30	during treatment planning	Doses in organs at risk: heart V30: the volumes (%) of the heart that received \>= 30Gy
PTV Coverage in Organs at Risk: MLD (Gy)	during treatment planning	Doses in organs at risk: lung MLD (Mean Lung Dose)

Trial Locations

Locations (1)

Maastricht Radiation Oncology; 🇳🇱 Heerlen, Limburg, Netherlands