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Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IORT 21 Gy | Active Comparator | Single fraction 21 Gy Intraoperative Radiation Therapy for breast tumors with diameter between 10 and 25 mm |
|
| IORT 18 Gy | Experimental | Single fraction 18 Gy Intra Operative Radiation Therapy in breast tumors smaller than 10 mm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 21 Gy radiation | Radiation | 21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early toxicity | Assessment of early toxicity using modified RTOG scale | 6 months |
| Late toxicity | Assessment of late toxicity using modified LENT scale | 5 years |
| Cosmetic outcome | Assessment of cosmetic outcome according to semi-objective criteria | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local Relapse Free Survival (LRFS) | Local recurrence rate will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data | 10 years |
| Disease Free Survival (DFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina Guenzi, MD | IRCCS AOU SanMartino IST | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS AOU San Martino- IST | Genoa | 16132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22493397 | Background | Guenzi 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. | |
| 30194205 | Derived |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 18 Gy radiation | Radiation | 18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV) |
|
Disease Free Survival will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data
| 10 years |
| Bonzano 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. |
| D017437 |
| Skin and Connective Tissue Diseases |