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Prone Breast Irradiation for Pendulous Breasts

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ClinicalTrials.gov Identifier: NCT00181363
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
Maastricht University
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Mamma board Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts
Study Start Date : December 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : January 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Mamma board
use of the mamma board during radiotherapy
 Device: Mamma board
use of mamma board during radiotherapy
Other Name: radiation, prone breast, mammaboard


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. PTV Coverage in Organs at Risk: MLD (Gy) [ Time Frame: during treatment planning ]
    Doses in organs at risk: lung MLD (Mean Lung Dose)

  2. PTV Coverage in Organs at Risk: Heart V30 [ Time Frame: during treatment planning ]
    Doses in organs at risk: heart V30: the volumes (%) of the heart that received >= 30Gy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181363


Locations
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Netherlands
Maastricht Radiation Oncology
Heerlen, Limburg, Netherlands, 6419 PC
Sponsors and Collaborators
Maastricht Radiation Oncology
Maastricht University
Investigators
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Principal Investigator: Jeroen Buijsen, MD Maastricht Radiation Oncology
More Information
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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT00181363    
Other Study ID Numbers: P03.1446L
First Posted: September 16, 2005    Key Record Dates
Results First Posted: January 28, 2020
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maastricht Radiation Oncology:
Breast cancer
Breast conserving surgery
Radiotherapy
Pendulous breasts
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases