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Clinical Trials/NCT00181363
NCT00181363
Completed
Not Applicable

Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts

Maastricht Radiation Oncology1 site in 1 country10 target enrollmentDecember 2003
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Maastricht Radiation Oncology
Enrollment
10
Locations
1
Primary Endpoint
Dose Homogeneity 1: PTV
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2003
End Date
January 2007
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Maastricht Radiation Oncology
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Dose Homogeneity 1: PTV

Time Frame: 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 %

Time Frame: 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%

Time Frame: 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 Outcomes

  • PTV Coverage in Organs at Risk: Heart V30(during treatment planning)
  • PTV Coverage in Organs at Risk: MLD (Gy)(during treatment planning)

Study Sites (1)

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