Clinical trial · Interventional
Intraoperative Radiotherapy for Korean Patients With Breast Cancer
A Phase II Trial Investigating Acute Local Toxicities of Intraoperative Radiotherapy as a Boost Dose in Korean Breast Cancer Patients Undergoing Breast Conserving Surgery
NCT02213991CI-TRIAL-00031701unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate acute local toxicity of IORT at the dose of 20 Gy for the replacement of boost-external beam radiotherapy in Korean women who are candidates for breast-conserving treatment.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative radiotherapy using Intrabeam® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative Radiotherapy
- description
- Intervention: Intraoperative Radiotherapy \* Operation day * Breast conservative surgery + Intraoperative radiotherapy 20 Gy Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity. Purse string suture pulles up tissues and wraps up the applicator. IORT with 20Gy is followed. After IORT, applicator was out of the operative field, and usual wound closure will be done. \* Postoperative period * ± Chemotherapy * WBRT (46 Gy) for 4\~5 weeks * ± Endocrine therapy or target therapy
- interventionNames
- Device: Intraoperative radiotherapy using Intrabeam®
Primary outcomes (1)
- measure
- Acute local toxicity in breast receiving IORT
- timeFrame
- Up to 6 months
- description
- Acute local toxicities of ipsilateral breast occurred within 6 months after IORT Local toxicity checklist * Hematoma needing surgical evacuation * Seroma needing more than three aspirations * Skin breakdown or delayed wound healing * Any complication needing surgical intervention * Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other. * Any complication of RTOG toxicity grade more than 2 Expected number of patients with acute local toxicites associated with IORT-booster treatement is 32. Considering a drop-out rate of 10%, the trial would need to enroll 215 patients in total.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed and newly diagnosed non-metastatic operable primary breast cancer * Primary tumor \<5cm, measured by ultrasonography - N0-3 (any N if resectable) and no evidence of distant metastasis (M) (isolated supraclavicular node involvement allowed) * Age ≥18-years women with good performance status (ECOG 0-1) * No breast operation is allowed except diagnostic biopsy * Women with ductal carcinoma in situ diagnosed by preoperative biopsy are allowed Exclusion Criteria: * Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential. * Patients who received prior chemotherapy or radiotherapy for breast cancer * Patients who have history of cancer other than in situ uterine cervix cancer or non-melanoma skin cancer * The depth of tumor from skin measured by ultrasonography is less than 1cm. * Contraindications to breast conservative surgery * Multicentric breast cancer (tumors in more than one quadrant) * Diffuse malignant appearing microcalcification * Prior therapeutic radiation to the breast region * Small breast, which is not possible to achieve clear margins in relation to a cosmetically acceptable result * History of collagen vascular disease, such as active scleroderma and active lupus * Postoperative exclusion * Patients who require re-excision due to positive resection margin * The depth of cavity from skin after lumpectomy is less than 0.5cm
References
Publications (2)
- DERIVEDBaek SH, Bae SJ, Kook Y, Cho Y, Ahn SG, Kim JW, Lee IJ, Jeong J. Long-term oncologic outcome of intraoperative radiotherapy (IORT) with low-energy X-rays as a tumor-bed boost in Korean patients with breast cancer. Cancer Treat Res Commun. 2025;43:100925. doi: 10.1016/j.ctarc.2025.100925. Epub 2025 Apr 14. PMID 40252397
- DERIVEDAhn SG, Bae SJ, Lee HW, Yoon CI, Kim JW, Lee IJ, Jeong J. A phase II study investigating the acute toxicity of targeted intraoperative radiotherapy as tumor-bed boost plus whole breast irradiation after breast-conserving surgery in Korean patients. Breast Cancer Res Treat. 2019 Feb;174(1):157-163. doi: 10.1007/s10549-018-5038-x. Epub 2018 Nov 22. PMID 30467660