Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis
Conditions
Breast Carcinoma
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: radiation in prone position Type: Behavioral
Name: radiation in supine position Type: Behavioral
Overall Status
Recruiting
Summary
84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- female patients

- multidisciplinary decision of adjuvant whole-breast irradiation (WBI) after lumpectomy for breast cancer

- minimum 18 years

- informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

- mastectomy

- need for axillary irradiation

- bilateral breast irradiation

- previous irradiation at the same time

- mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study

- patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Location
University Hospital Ghent
Ghent, Belgium
Status: Recruiting
Contact: Wilfried De Neve, MD, PhD - wilfried.deneve@uzgent.be
Start Date
July 2009
Completion Date
December 2015
Sponsors
University Hospital, Ghent
Source
University Hospital, Ghent
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page