Clinical trial · Interventional
Accelerated Partial Breast Irradiation With 3D-CRT and IMRT
Accelerated Partial Breast Irradiation After Breast Conserving Surgery for Low-risk Invasive Breast Cancer: 3D Conformal Radiotherapy (3D-CRT) and Intensity Modulated Radiotherapy (IMRT) - Prospective Phase II Study
- 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)
The purpose of this study is to determine in a phase II clinical trial whether accelerated partial breast irradiation after breast conserving surgery using 3 dimensional external beam radiotherapy (3D-CRT) and intensity modulated radiotherapy (IMRT) for low-risk invasive breast cancer patients is safe without causing serious late radiation side-effects.
Conditions
Conditions (3)
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 | — |
| Side Effects | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| accelerated partial breast irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Accelerated partial breast irradiation
- description
- Accelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy
- interventionNames
- Radiation: accelerated partial breast irradiation
Primary outcomes (1)
- measure
- late radiation side-effect
- timeFrame
- 5 years
- description
- Late radiation side-effects at 5 years scored by the RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer) late radiation morbidity scoring scheme
Secondary outcomes (6)
- measure
- cosmetic results
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * previous breast conserving surgery within 12 weeks (in case of adjuvant chemotherapy within 28 days after completion of chemotherapy) * patient age \> 40 years * ECOG performance status: 0-1 * life expectancy \>5 years * invasive ductal, papillary, mucinous, medullary or tubular carcinoma * unifocal tumor * pathological tumor size \< or = 30 mm * pathological negative axillary nodal status with axillary dissection or sentinel lymph node biopsy * surgical clips in the tumor bed * pathological surgical free margins of at least 2 mm * written informed consent of patients Exclusion Criteria: * Stage III-IV * multifocal tumor * extensive intraductal component (EIC) * ductal or lobular carcinoma in situ (DCIS or LCIS) * invasive lobular cancer (ILC) * lymph-vascular invasion (LVI) * contralateral breast cancer * history of treatment for previous breast cancer * lactation or breast feeding women * Paget-disease of the nipple * psychiatric disorder * increased radiosensitivity (e.g. collagen vascular disease)
References
Publications (1)
- DERIVEDMozsa E, Meszaros N, Major T, Frohlich G, Stelczer G, Sulyok Z, Fodor J, Polgar C. Accelerated partial breast irradiation with external beam three-dimensional conformal radiotherapy. Five-year results of a prospective phase II clinical study. Strahlenther Onkol. 2014 May;190(5):444-50. doi: 10.1007/s00066-014-0633-1. Epub 2014 Mar 12. PMID 24619017