Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment mamma board
Sponsor Maastricht Radiation Oncology
Collaborator Maastricht University Medical Center
Start date December 2003
End date January 2010
Trial size 10 participants
Trial identifier NCT00181363, P03.1446L

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 and normal tissues in prone position versus supine position.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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.
time frame:

Secondary Outcomes

Measure
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
time frame:
PTV coverage (% of PTV < 95% of prescribed dose),Doses in organs at risk (heart: V30, V40, V50, lung: V20, MLD)
time frame:

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts
Principal investigator Jeroen Buijsen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Maastricht Radiation Oncology.