Trial Information
Randomized Controlled 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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
acute moist desquamation
Outcome Time Frame:
weekly during radiotherapy and 1 month after radiotherapy
Safety Issue:
Yes
Principal Investigator
Wilfried De Neve, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Ghent
Authority:
Belgium: Institutional Review Board
Study ID:
2009/184
NCT ID:
NCT00887523
Start Date:
July 2009
Completion Date:
March 2013
Related Keywords:
- Breast Carcinoma
- Breast Neoplasms
- Carcinoma
- Fibrosis
