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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MARA-1: accelerated hypofractionated RT | A forward planned IMRT technique was used and the prescribed dose to the breast was 40 Gy in 16 fx with a concomitant boost of 4 Gy. |
| |
| CG: conventional fractionated RT | In the CG, the whole breast received 50.4 Gy in 28 fractions (fx) delivered with 3D-RT, followed by a sequential boost on the tumour bed of 10 Gy in 4 fx delivered with electrons |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| accelerated hypofractionated RT | Radiation |
| ||
| conventional fractionated RT |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related late adverse events | late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related acute adverse events | acute toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients | 6 months |
| local control | absence of locoregional relapse |
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Inclusion Criteria:
Exclusion Criteria:
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From 2003, all women fullfilling the inclusion criteria were treated with MARA-1 scheme
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| Name | Affiliation | Role |
|---|---|---|
| Alessio G. Morganti, MD | Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30323658 | Derived | Digesu C, Deodato F, Macchia G, Cilla S, Pieri M, Zamagni A, Farioli A, Buwenge M, Ferrandina G, Morganti AG. Hypofractionated radiotherapy after conservative surgery may increase low-intermediate grade late fibrosis in breast cancer patients. Breast Cancer (Dove Med Press). 2018 Oct 3;10:143-151. doi: 10.2147/BCTT.S167914. eCollection 2018. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Radiation |
|
| 5 years |
| overall survival | defined as the time from diagnosis to death | 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |