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The intraoperative radiotherapy machine was out of order and could not be used.
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To compare the satisfaction with conserved breast, acute and chronic postoperative complications and tumor control between intraoperative radiotherapy(IORT) and traditional postoperative radiotherapy following breast-conserving surgery (BCS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IORT | Experimental | intraoperative radiotherapy(IORT) in BCS. |
|
| PORT | Active Comparator | traditional postoperative radiotherapy following BCS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraoperative radiotherapy | Radiation | intraoperative radiotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful surgical procedure | the rate of successful breast conserving surgery | immediately after surgery |
| satisfaction with conserved breast | the patients' satisfaction to postoperative breast including shape and feeling(Harvard/NSABP/RTOG BREAST COSMETIC SCALE: excellent, good, fair, poor) | 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute and chronic postoperative complications（CTCAE 3.0) | The incidence of adverse reactions at 1 and 6 months after operation | 1-month, 6-month after surgery |
| DFS | long-term postoperative disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ZONG, MD, PhD | Shanghai Jiao Tong University affiliated 6th Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32494808 | Background | Kawamura M, Itoh Y, Kamomae T, Sawaki M, Kikumori T, Tsunoda N, Ito J, Shimoyama Y, Satake H, Naganawa S. A phase I/II trial of intraoperative breast radiotherapy in an Asian population: 10-year results with critical evaluation. J Radiat Res. 2020 Jul 6;61(4):602-607. doi: 10.1093/jrr/rraa029. | |
| 32943994 | Background |
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| postoperative radiotherapy |
| Radiation |
postoperative radiotherapy |
|
| 2-3 years after surgery |
| OS | long-term postoperative overall survival | 2-3 years after surgery |
| Wang L, Zhu M, Cui Y, Zhang X, Li G. Efficacy analysis of intraoperative radiotherapy in patients with early-stage breast cancer. Cancer Cell Int. 2020 Sep 11;20:446. doi: 10.1186/s12935-020-01533-z. eCollection 2020. |
| 32487184 | Background | Forster T, Jakel C, Akbaba S, Krug D, Krempien R, Uhl M, Hafner MF, Konig L, Koerber SA, Harrabi S, Bernhardt D, Behnisch R, Krisam J, Hennigs A, Sohn C, Heil J, Debus J, Horner-Rieber J. Fatigue following radiotherapy of low-risk early breast cancer - a randomized controlled trial of intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy: the COSMOPOLITAN trial (NCT03838419). Radiat Oncol. 2020 Jun 1;15(1):134. doi: 10.1186/s13014-020-01581-9. |
| 33224829 | Background | Hu X, He Y, Chen X, Xia T, Cao T, Jia H, Zhang L. Impact of intraoperative radiotherapy on the perioperative period of patients after breast-conserving surgery. Gland Surg. 2020 Oct;9(5):1535-1542. doi: 10.21037/gs-20-727. |
| 31660047 | Background | Gondim GRM, Makdissi FBA, Fogaroli RC, Collins JBD, Iyeyasu H, de Castro DG, Silva MLG, Chen MJ, Coelho TM, Ramos H, Pellizzon ACA. Intraoperative breast radiotherapy: survival, local control and risk factors for recurrence. Rep Pract Oncol Radiother. 2019 Nov-Dec;24(6):551-555. doi: 10.1016/j.rpor.2019.09.004. Epub 2019 Oct 16. |
| 32030446 | Background | Uhlig S, Wuhrer A, Berlit S, Tuschy B, Sutterlin M, Bieback K. Intraoperative radiotherapy for breast cancer treatment efficiently targets the tumor bed preventing breast adipose stromal cell outgrowth. Strahlenther Onkol. 2020 Apr;196(4):398-404. doi: 10.1007/s00066-020-01586-z. Epub 2020 Feb 6. |
| 33087894 | Background | Sasieni PD, Sawyer EJ. Intraoperative radiotherapy for early breast cancer - insufficient evidence to change practice. Nat Rev Clin Oncol. 2020 Dec;17(12):723-724. doi: 10.1038/s41571-020-00444-2. |
| 33495552 | Background | Vaidya JS, Bulsara M, Baum M, Alvarado M, Bernstein M, Massarut S, Saunders C, Sperk E, Wenz F, Tobias JS; TARGIT-A investigators. Intraoperative radiotherapy for breast cancer: powerful evidence to change practice. Nat Rev Clin Oncol. 2021 Mar;18(3):187-188. doi: 10.1038/s41571-021-00471-7. No abstract available. |
| 32816842 | Background | Vaidya JS, Bulsara M, Baum M, Wenz F, Massarut S, Pigorsch S, Alvarado M, Douek M, Saunders C, Flyger HL, Eiermann W, Brew-Graves C, Williams NR, Potyka I, Roberts N, Bernstein M, Brown D, Sperk E, Laws S, Sutterlin M, Corica T, Lundgren S, Holmes D, Vinante L, Bozza F, Pazos M, Le Blanc-Onfroy M, Gruber G, Polkowski W, Dedes KJ, Niewald M, Blohmer J, McCready D, Hoefer R, Kelemen P, Petralia G, Falzon M, Joseph DJ, Tobias JS. Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial. BMJ. 2020 Aug 19;370:m2836. doi: 10.1136/bmj.m2836. |
| 33224814 | Background | Onthong K, Chakkabat C, Nantavithya C, Shotelersuk K, Denariyakoon S, Vongsaisuwon M, Chulakadabbav A, Chatamra K, Saksornchai K. Results of intraoperative radiotherapy given as a boost after breast conserving-surgery. Gland Surg. 2020 Oct;9(5):1389-1395. doi: 10.21037/gs-20-249. |
| 33531693 | Background | Vaidya JS, Bulsara M, Baum M, Tobias JS; TARGIT-A trial authors. Single-dose intraoperative radiotherapy during lumpectomy for breast cancer: an innovative patient-centred treatment. Br J Cancer. 2021 Apr;124(9):1469-1474. doi: 10.1038/s41416-020-01233-5. Epub 2021 Feb 2. |
| 32774999 | Background | Feng K, Meng X, Liu J, Xing Z, Zhang M, Wang X, Feng Q, Wang X. Update on intraoperative radiotherapy for early-stage breast cancer. Am J Cancer Res. 2020 Jul 1;10(7):2032-2042. eCollection 2020. |