Trial Information
Comparison of Set-up Reproducibility Between Prone and Supine Intensity Modulated Radiotherapy (IMRT) for the Adjuvant Treatment of Breast Carcinoma After Lumpectomy
Inclusion Criteria:
- female patients
- multidisciplinary decision of adjuvant radiotherapy 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
- pregnant or breastfeeding
- 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:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Random set-up error
Outcome Time Frame:
daily during radiotherapy
Safety Issue:
No
Principal Investigator
Wilfried De Neve, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Ghent
Authority:
Belgium: Institutional Review Board
Study ID:
2009/185
NCT ID:
NCT00887692
Start Date:
July 2009
Completion Date:
October 2010
Related Keywords:
- Breast Carcinoma
- Breast Neoplasms
- Carcinoma