Trial Outcomes & Findings for Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast (NCT NCT00556907)
NCT ID: NCT00556907
Last Updated: 2025-11-06
Results Overview
These are the rates of reoperation for re-excision or mastectomy following Wide Local Excision (WLE) or Intraoperative Radiation Therapy (IORT). The number of patients who required reoperation were reported below.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
30 days
Results posted on
2025-11-06
Participant Flow
Participant milestones
| Measure |
Intraoperative Radiotherapy
Patients will receive IORT
Intraoperative radiotherapy: 20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
Intraoperative radiotherapy: 20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast
Baseline characteristics by cohort
| Measure |
Intraoperative Radiotherapy
n=36 Participants
Patients will receive IORT
Intraoperative radiotherapy: 20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
Intraoperative radiotherapy: 20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed
|
|---|---|
|
Age, Continuous
|
57 Years
|
|
Sex: Female, Male
Female
|
36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
|
|
Region of Enrollment
United States
|
36 participants
|
PRIMARY outcome
Timeframe: 30 daysThese are the rates of reoperation for re-excision or mastectomy following Wide Local Excision (WLE) or Intraoperative Radiation Therapy (IORT). The number of patients who required reoperation were reported below.
Outcome measures
| Measure |
Intraoperative Radiotherapy
n=35 Participants
Patients will receive IORT
Intraoperative radiotherapy: 20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
Intraoperative radiotherapy: 20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed
|
|---|---|
|
Reoperation (Re-excision or Mastectomy) Rates Following WLE or IORT
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 yearsAssessment of the overall serious adverse event rate.
Outcome measures
| Measure |
Intraoperative Radiotherapy
n=36 Participants
Patients will receive IORT
Intraoperative radiotherapy: 20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
Intraoperative radiotherapy: 20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed
|
|---|---|
|
Number of Serious Adverse Events.
|
0 events
|
Adverse Events
Intraoperative Radiotherapy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intraoperative Radiotherapy
n=36 participants at risk
Patients will receive IORT
Intraoperative radiotherapy: 20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
Intraoperative radiotherapy: 20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed
|
|---|---|
|
Reproductive system and breast disorders
Breast Pain
|
5.6%
2/36 • Up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Breast infection/abscess
|
2.8%
1/36 • Up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Edema
|
5.6%
2/36 • Up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • Up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Fibrosis
|
2.8%
1/36 • Up to 2 years.
|
|
Skin and subcutaneous tissue disorders
hyperpigmentation
|
2.8%
1/36 • Up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Seroma
|
2.8%
1/36 • Up to 2 years.
|
|
Vascular disorders
Hematoma
|
2.8%
1/36 • Up to 2 years.
|
|
Renal and urinary disorders
urinary retention
|
2.8%
1/36 • Up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
2.8%
1/36 • Up to 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place