Breast Cancer, Radiation Toxicity
Conditions
Keywords
breast cancer, radiotherapy, cutaneous toxicity, subcutaneous toxicity, IMRT
Brief summary
This trial was a retrospective study on postoperative accelerated hypofractionated IMRT (MARA-1) in patients with early stage breast carcinoma, to compare late toxicity after this treatment and standard fractionated RT delivered with 3D-CRT.
Detailed description
The aim of this study was to evaluate the clinical results in terms of late skin and subcutaneous toxicity of accelerated hypofractionated forward-planned IMRT in patients with early stage BC. Results were compared with a historical control group (CG) of patients treated with 3D-conformal postoperative RT delivered with conventional fractionation.
Interventions
RADIATIONaccelerated hypofractionated RT
RADIATIONconventional fractionated RT
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* confirmed histologic evidence of pTis-pT3 breast cancer * breast conservative surgery * post menopausal status * clear surgical margin
Exclusion criteria
* pT4 * positive or close resection margins * 3 or more metastatic axillary nodes * nodal irradiation * M1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-related late adverse events | 5 years | late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-related acute adverse events | 6 months | acute toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients |
| local control | 5 years | absence of locoregional relapse |
| overall survival | 5 years | defined as the time from diagnosis to death |
Outcome results
None listed