Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

Comparison of Satisfaction With Conserved Breast, Postoperative Complications and Tumor Control Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

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).

Study Overview

• Status: Terminated
• Conditions: Quality of Life
• Intervention / Treatment: Radiation: intraoperative radiotherapy; Radiation: postoperative radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary invasive breast cancer confirmed by pathology.
• 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:

• Previous history of breast cancer or other malignant tumors.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IORT; intraoperative radiotherapy(IORT) in BCS.	Radiation: intraoperative radiotherapy; intraoperative radiotherapy
Active Comparator: PORT; traditional postoperative radiotherapy following BCS.	Radiation: postoperative radiotherapy; postoperative radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	2-3 years after surgery
OS	long-term postoperative overall survival	2-3 years after surgery

Collaborators and Investigators

• Sponsor: Xiangyun Zong
• Investigators: Study Director: ZONG, MD, PhD, Shanghai Jiao Tong University affiliated 6th Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: intraoperative radiotherapy; breast-conserving surgery
• Other Study ID Numbers: JTU-6H-20210227001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No