Clinical trial · Interventional
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
NCT04789889CI-TRIAL-00090452terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The intraoperative radiotherapy machine was out of order and could not be used.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraoperative radiotherapy | Radiation | — | UNRESOLVED |
| postoperative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IORT
- description
- intraoperative radiotherapy(IORT) in BCS.
- interventionNames
- Radiation: intraoperative radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- PORT
- description
- traditional postoperative radiotherapy following BCS.
- interventionNames
- Radiation: postoperative radiotherapy
Primary outcomes (2)
- measure
- Rate of successful surgical procedure
- timeFrame
- immediately after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (12)
- BACKGROUNDKawamura 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
- BACKGROUNDWang 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
- BACKGROUNDForster 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
- BACKGROUNDHu 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
- BACKGROUNDGondim 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
- BACKGROUNDUhlig 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.