Trial Information
Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated Intensity Modulated Radiotherapy (IMRT) in Treatment of Breast Cancer: The KOSIMA Trial
Inclusion Criteria:
- Histologically confirmed invasive or in situ breast cancer, tumor stage pTis-pT3,
pN0-1a, M0
- Age ≥ 60 years
- signed informed consent from the patient
Exclusion Criteria:
- Stage pN1b-PN3, pT4 and / or M1
- incomplete surgical resection
- after mastectomy of the ipsilateral or contralateral breast
- breast reconstruction with implant or expander insert
- bilateral breast cancer
- Lack of compliance or consent
- Indications for irradiation of the axillary, supraclavicular or parasternal lymph
nodes
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
acute and chronic cosmetic outcome
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Frederik Wenz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UMM
Authority:
Germany: Ethics Commission
Study ID:
MA-KOSIMA-01
NCT ID:
NCT01403779
Start Date:
July 2010
Completion Date:
July 2012
Related Keywords:
- Tumors
- Breast Cancer
- Intensity-Modulated Radiation Therapy (IMRT)
- Breast cancer
- Hypofractionation
- Breast Neoplasms