Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery
NCT ID: NCT04789889
Last Updated: 2025-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
80 participants
INTERVENTIONAL
2021-03-01
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IORT
intraoperative radiotherapy(IORT) in BCS.
intraoperative radiotherapy
intraoperative radiotherapy
PORT
traditional postoperative radiotherapy following BCS.
postoperative radiotherapy
postoperative radiotherapy
Interventions
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intraoperative radiotherapy
intraoperative radiotherapy
postoperative radiotherapy
postoperative radiotherapy
Eligibility Criteria
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Inclusion Criteria
* Maximum tumor diameter ≤3.5cm.
* Clinical lymph nodes are negative.
* Single or multiple tumors are located on the same side of the nipple and in the same quadrant.
* ECOG status score ≤ 2.
* With informed Consents.
Exclusion Criteria
* Inflammatory breast cancer; 3. Previous radiotherapy history.
* Other diseases affecting radiotherapy, such as connective tissue disease, heart disease, lung disease and so on.
* Patients who are not going to have the axillary lymph node surgery (including SLN and ALND) were excluded.
18 Years
70 Years
FEMALE
No
Sponsors
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Xiangyun Zong
OTHER
Responsible Party
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Xiangyun Zong
Director of Breast Cancer
Principal Investigators
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ZONG, MD, PhD
Role: STUDY_DIRECTOR
Shanghai Jiao Tong University affiliated 6th Hospital
Locations
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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JTU-6H-20210227001
Identifier Type: -
Identifier Source: org_study_id
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