Clinical trial · Interventional
Exclusive Intraoperative Radiation Therapy for Breast Cancer
Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment
NCT01276938CI-TRIAL-00027784completedPhase 2 / Phase 3ClinicalTrials.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)
Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18 Gy radiation | Radiation | — | UNRESOLVED |
| 21 Gy radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- IORT 21 Gy
- description
- Single fraction 21 Gy Intraoperative Radiation Therapy for breast tumors with diameter between 10 and 25 mm
- interventionNames
- Radiation: 21 Gy radiation
- type
- EXPERIMENTAL
- label
- IORT 18 Gy
- description
- Single fraction 18 Gy Intra Operative Radiation Therapy in breast tumors smaller than 10 mm.
- interventionNames
- Radiation: 18 Gy radiation
Primary outcomes (3)
- measure
- Early toxicity
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Non lobular epithelial breast carcinoma, excised with standard quadrantectomy * Age ≥ 45 and \< 85 * Tumor major diameter ≤ 2.5 cm * Negative surgical margins (≥ 5 mm) * Willingness to undergo follow up examinations * Willingness to undergo imaging examinations (MRI, mammograms, ultrasonography) * Signed informed consent Exclusion Criteria: * Ductal carcinoma in situ or lobular carcinoma * Extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion * Serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements * Pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device) * Collagen vascular disorders
References
Publications (2)
- BACKGROUNDGuenzi M, Fozza A, Timon G, Belgioia L, Vidano G, Cavagnetto F, Agostinelli S, Gusinu M, Carli F, Cafiero F, Friedman D, Canavese G, Corvo R. A two-step selection of breast cancer patients candidates for exclusive IORT with electrons: a mono-institutional experience. Anticancer Res. 2012 Apr;32(4):1533-6. PMID 22493397
- DERIVEDBonzano E, Belgioia L, Fregatti P, Friedman D, Agostinelli S, Cavagnetto F, Bevegni M, Corvo R, Guenzi M. Tumor Size-driven Dose of Intraoperative Radiotherapy for Breast Cancer: 18 Gy Versus 21 Gy. Anticancer Res. 2018 Sep;38(9):5475-5479. doi: 10.21873/anticanres.12880. PMID 30194205