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Prone Breast Irradiation for Pendulous Breasts

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Maastricht Radiation Oncology.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Maastricht University Medical Center
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00181363
First received: September 9, 2005
Last updated: April 25, 2007
Last verified: April 2007
  Purpose

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 and normal tissues in prone position versus supine position.


Condition Intervention
Breast Cancer
Device: Mamma board

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • In 10 patients a conventional simulation will be done in supine and prone position. A planning CT-scan will be obtained in both positions. A lead wire will be placed around the palpable breast tissue as an aid in the delineation.

Secondary Outcome Measures:
  • Volume of the CTV (cc),Maximum dose delivered in at least 1 cc,Minimum dose in PTV, delivered in at least 1% of the PTV
  • PTV coverage (% of PTV < 95% of prescribed dose),Doses in organs at risk (heart: V30, V40, V50, lung: V20, MLD)

Estimated Enrollment: 10
Study Start Date: December 2003
Estimated Study Completion Date: January 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients should have had breast-conserving surgery for breast cancer or DCIS
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181363

Locations
Netherlands
Maastricht Radiation Oncology
Heerlen, Limburg, Netherlands, 6419 PC
Sponsors and Collaborators
Maastricht Radiation Oncology
Maastricht University Medical Center
Investigators
Principal Investigator: Jeroen Buijsen, MD Maastricht Radiation Oncology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00181363     History of Changes
Other Study ID Numbers: P03.1446L
Study First Received: September 9, 2005
Last Updated: April 25, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
Breast cancer
Breast conserving surgery
Radiotherapy
Pendulous breasts

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014