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This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer
Patients enrolled for the study, according to eligibility criteria, undergo breast conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk adapted simultaneous-integrated boost dose at the level of the tumour bed according to clinical and pathological risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simultaneous integrated boost to 40 Gy (SIB 40) | Active Comparator | Patients with the following clinico-pathological characteristics
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| Simultaneous integrated boost to 43 Gy (SIB 43) | Active Comparator | Patients with the following clinico-pathological characteristics:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost | Radiation | Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 40 Gy |
| Measure | Description | Time Frame |
|---|---|---|
| Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale | Incidence of grade 2-3 late toxicity in terms of skin toxicity | From the end of treatment at 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of local tumor relapse, distant metastasis and assessment of overall survival | Identification of local tumor relapse in the breast parenchyma within boost volume, breast parenchyma within volume receiving 34Gy; identification of distant metastasis and analysis of overall survival | Time from the date of the diagnosis of primary breast cancer to the date of diagnosis of local relapse, distant metastasis or death from any cause, assessed up to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regina Elena Cancer Institute | Rome | Lazio | 00144 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37302395 | Result | Coles CE, Haviland JS, Kirby AM, Griffin CL, Sydenham MA, Titley JC, Bhattacharya I, Brunt AM, Chan HYC, Donovan EM, Eaton DJ, Emson M, Hopwood P, Jefford ML, Lightowlers SV, Sawyer EJ, Syndikus I, Tsang YM, Twyman NI, Yarnold JR, Bliss JM; IMPORT Trial Management Group. Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): a multicentre, phase 3, non-inferiority, open-label, randomised controlled trial. Lancet. 2023 Jun 24;401(10394):2124-2137. doi: 10.1016/S0140-6736(23)00619-0. Epub 2023 Jun 8. | |
| 29282078 |
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Two test groups. Phase 2 study because of 2 test groups with 2 types of SIB. A Simultaneous integrated boost to 40 Gy (SIB 40): 34 Gy to the ipsilateral breast with concomitant boost to 40 Gy to the tumor bed. A Simultaneous integrated boost to 43 Gy (SIB 43): 34 Gy to the ipsilateral breast with concomitant boost to 43 Gy to the tumor bed
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| Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost | Radiation | Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy |
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| Result |
| Pinnaro P, Giordano C, Farneti A, Faiella A, Iaccarino G, Landoni V, Giannarelli D, Vici P, Strigari L, Sanguineti G. Short course hypofractionated whole breast irradiation after conservative surgery: a single institution phase II study. J Exp Clin Cancer Res. 2017 Dec 27;36(1):191. doi: 10.1186/s13046-017-0640-z. |
| 20100335 | Result | Pinnaro P, Soriani A, Landoni V, Giordano C, Papale M, Marsella A, Marucci L, Arcangeli G, Strigari L. Accelerated hypofractionated radiotherapy as adjuvant regimen after conserving surgery for early breast cancer: interim report of toxicity after a minimum follow up of 3 years. J Exp Clin Cancer Res. 2010 Jan 25;29(1):9. doi: 10.1186/1756-9966-29-9. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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