Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

NCT04789889 | Terminated DMC

• 1 other identifier: JTU-6H-20210227001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Quality of Life

Keywords

intraoperative radiotherapy; breast-conserving surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Rate of acute and chronic postoperative complications（CTCAE 3.0)

  1-month, 6-month after surgery

• DFS

  2-3 years after surgery

• OS

  2-3 years after surgery

Study Arms (2)

IORT

EXPERIMENTAL

intraoperative radiotherapy(IORT) in BCS.

Radiation: intraoperative radiotherapy

PORT

ACTIVE COMPARATOR

traditional postoperative radiotherapy following BCS.

Radiation: postoperative radiotherapy

Interventions

intraoperative radiotherapy RADIATION

intraoperative radiotherapy

IORT

postoperative radiotherapy RADIATION

postoperative radiotherapy

PORT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangyun Zong: lead

Study Sites (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Related Publications (12)

• 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.

  PMID: 32494808 BACKGROUND

• 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.

  PMID: 32943994 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.

  PMID: 32487184 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.

  PMID: 33224829 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.

  PMID: 31660047 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.

  PMID: 32030446 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.

  PMID: 33087894 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.

  PMID: 33495552 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.

  PMID: 32816842 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.

  PMID: 33224814 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.

  PMID: 33531693 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.

  PMID: 32774999 BACKGROUND

Study Officials

• ZONG, MD, PhD

  Shanghai Jiao Tong University affiliated 6th Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Breast Cancer

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 10, 2021
• Study Start: March 1, 2021
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: June 2, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)