CClinicalTrials.gg
Sign In
TerminatedNCT04789889Updated Jun 2, 2025

Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

An interventional study of intraoperative radiotherapy and postoperative radiotherapy in Quality of Life, sponsored by Xiangyun Zong. Terminated at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-02.

Sponsored by Xiangyun Zong · Not applicable, Interventional, and Treatment

Why this study was terminated
The intraoperative radiotherapy machine was out of order and could not be used.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

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).

02

Conditions studied

  • Quality of Life

Keywords

  • intraoperative radiotherapy
  • breast-conserving surgery
03

In context

Lead sponsor

Xiangyun Zong is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    IORT

    intraoperative radiotherapy(IORT) in BCS.

    Radiation: intraoperative radiotherapy

  • Active comparator
    PORT

    traditional postoperative radiotherapy following BCS.

    Radiation: postoperative radiotherapy

Interventions

  • Radiationintraoperative radiotherapy

    intraoperative radiotherapy

  • Radiationpostoperative radiotherapy

    postoperative radiotherapy

06

What researchers measure

Primary outcomes

  1. Rate of successful surgical procedure

    the rate of successful breast conserving surgery

    Time frame: immediately after surgery

  2. satisfaction with conserved breast

    the patients' satisfaction to postoperative breast including shape and feeling(Harvard/NSABP/RTOG BREAST COSMETIC SCALE: excellent, good, fair, poor)

    Time frame: 1 month after surgery

Secondary outcomes

  1. Rate of acute and chronic postoperative complications（CTCAE 3.0)

    The incidence of adverse reactions at 1 and 6 months after operation

    Time frame: 1-month, 6-month after surgery

  2. DFS

    long-term postoperative disease-free survival

    Time frame: 2-3 years after surgery

  3. OS

    long-term postoperative overall survival

    Time frame: 2-3 years after surgery

07

Study locations

1 site
  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
    Shanghai, Shanghai 200233, China
08

References and documents

Publications

  • 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. PubMed 32494808 ↗
  • 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. PubMed 32943994 ↗
  • 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. PubMed 32487184 ↗
  • 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. PubMed 33224829 ↗
  • 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. PubMed 31660047 ↗
  • 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. PubMed 32030446 ↗
  • 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. PubMed 33087894 ↗
  • 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. PubMed 33495552 ↗
  • 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. PubMed 32816842 ↗
  • 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. PubMed 33224814 ↗
  • 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. PubMed 33531693 ↗
  • 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. PubMed 32774999 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04789889
Lead sponsor
Xiangyun Zong
Responsible party
Xiangyun Zong (Director of Breast Cancer, Shanghai Jiao Tong University Affiliated Sixth People's Hospital) — Sponsor-investigator
First posted
Mar 10, 2021
Start date
Mar 1, 2021
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025
Last update
Jun 2, 2025

Study contacts

ZONG, MD, PhD
study director · Shanghai Jiao Tong University affiliated 6th Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Xiangyun Zong

Start the discussion