Clinical trial · Observational
Modulated Accelerated RAdiotherapy in Early Breast Cancer
Postoperative Modulated Accelerated RAdiotherapy (MARA-1) for Early Stage Breast Cancer: a Retrospective Analysis
NCT03461224CI-TRIAL-00032028completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| accelerated hypofractionated RT | Radiation | — | UNRESOLVED |
| conventional fractionated RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- MARA-1: accelerated hypofractionated RT
- description
- 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.
- interventionNames
- Radiation: accelerated hypofractionated RT
- label
- CG: conventional fractionated RT
- description
- 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
- interventionNames
- Radiation: conventional fractionated RT
Primary outcomes (1)
- measure
- Incidence of treatment-related late adverse events
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDigesu 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. PMID 30323658