Trial results for a study investigating Targeted Intra-Operative Radiotherapy for Ductal Carcinoma In-Situ of the Breast were posted on 2025-11-06. The trial, which enrolled 36 participants, was terminated.
Background
Ductal Carcinoma In-Situ (DCIS) of the breast is a non-invasive form of breast cancer. Standard treatment often involves surgical resection, sometimes followed by additional radiotherapy to reduce recurrence risk. The trial hypothesized that combining mammography and CE-MRI could improve the ability of surgeons and radiologists to define the extent of the disease before surgery, thereby improving the chances of obtaining clear surgical margins. The aim was to increase the efficacy of intra-operative radiotherapy (IORT) delivered immediately after initial surgical resection, potentially allowing patients deemed eligible for 'immediate' IORT to be successfully treated without the need for re-excision or additional radiotherapy due to inadequate surgical margins.
Trial design
This study, with a phase designated as NA, enrolled 36 participants diagnosed with Breast Cancer. The trial investigated targeted intra-operative radiotherapy for the management of Ductal Carcinoma In-Situ of the Breast. The overall status of the trial is TERMINATED.
Key results
The study collected key measurements related to reoperation rates and adverse events:
- For the outcome of Reoperation (Re-excision or Mastectomy) Rates Following WLE or IORT in the Intraoperative Radiotherapy group, 8 participants required reoperation.
- The Number of Serious Adverse Events in the Intraoperative Radiotherapy group was reported as 0 events.
What this means
The termination of this trial, which aimed to reduce the need for re-excision or additional radiotherapy, indicates that the intervention may not have met its intended goals. A significant finding is that 8 out of 36 participants in the Intraoperative Radiotherapy group still required reoperation (re-excision or mastectomy). This suggests that the targeted intra-operative radiotherapy strategy, as implemented in this study, did not consistently achieve clear surgical margins or prevent the need for further surgical intervention in a notable proportion of patients. However, it is also notable that 0 serious adverse events were reported, suggesting the intervention itself did not lead to severe complications in the enrolled participants.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT00556907, titled "Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast," were posted on 2025-11-06 on clinicaltrials.gov.