Prone Breast Irradiation for Pendulous Breasts

NCT ID: NCT00181363

Last Updated: 2020-01-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mamma board

use of the mamma board during radiotherapy

Group Type EXPERIMENTAL

Mamma board

Intervention Type DEVICE

use of mamma board during radiotherapy

Interventions

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Mamma board

use of mamma board during radiotherapy

Intervention Type DEVICE

Other Intervention Names

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radiation, prone breast, mammaboard

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University

OTHER

Sponsor Role collaborator

Maastricht Radiation Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeroen Buijsen, MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht Radiation Oncology

Locations

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Maastricht Radiation Oncology

Heerlen, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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P03.1446L

Identifier Type: -

Identifier Source: org_study_id

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