Trial Outcomes & Findings for Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer (NCT NCT00182728)
NCT ID: NCT00182728
Last Updated: 2024-10-01
Results Overview
Rates of good/excellent cosmesis was evaluated using the following criteria: Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance. Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
COMPLETED
NA
89 participants
1 year follow up visit
2024-10-01
Participant Flow
March 2003 to July 2007
89 patients consented. Of those 89, 18 were not treated for the following reasons: tumor not seen on ultrasound (2), tumor too close to chest wall (7), tumor too large (1), ineligible pathology (1), ineligible nodal status (1), operating room logistical errors (3), patients withdrew (2), not eligible for anesthesia (1).
Participant milestones
| Measure |
Intraoperative Radiation Arm
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
COMPLETED
|
71
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer
Baseline characteristics by cohort
| Measure |
Intraoperative Radiation Arm
n=71 Participants
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy
|
|---|---|
|
Age, Continuous
|
64.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 Participants
n=5 Participants
|
|
Clinical Staging
cT1a
|
2 Participants
n=5 Participants
|
|
Clinical Staging
cT1b
|
18 Participants
n=5 Participants
|
|
Clinical Staging
cT1c
|
35 Participants
n=5 Participants
|
|
Clinical Staging
cT2 (<3 cm)
|
16 Participants
n=5 Participants
|
|
Clinical Staging
cN0
|
71 Participants
n=5 Participants
|
|
Grade
I
|
25 Participants
n=5 Participants
|
|
Grade
II
|
24 Participants
n=5 Participants
|
|
Grade
III
|
22 Participants
n=5 Participants
|
|
Markers
Estrogen Receptor (ER) positive
|
54 Participants
n=5 Participants
|
|
Markers
Progesterone Receptor (PR) positive
|
50 Participants
n=5 Participants
|
|
Markers
Human Epidermal Growth Factor receptor (HER) 2 pos
|
8 Participants
n=5 Participants
|
|
Markers
ER+, PR+, HER2-
|
46 Participants
n=5 Participants
|
|
Markers
"triple negative"
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year follow up visitPopulation: Patients who received intraoperative radiation therapy (IORT) alone. 56 patients were assessed.
Rates of good/excellent cosmesis was evaluated using the following criteria: Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance. Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
Outcome measures
| Measure |
Intraoperative Radiation Arm
n=56 Participants
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy
|
|---|---|
|
Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician
|
45 Participants
|
PRIMARY outcome
Timeframe: 1 year follow up visitPopulation: Patients who received IORT alone. 42 patients assessed their cosmetic outcome.
Rates of good/excellent cosmesis was evaluated using the following criteria: Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance. Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
Outcome measures
| Measure |
Intraoperative Radiation Arm
n=42 Participants
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy
|
|---|---|
|
Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Patients
|
32 Participants
|
PRIMARY outcome
Timeframe: 3 monthsSkin and subcutaneous toxicity were graded by a radiation oncologist according to the common terminology criteria for adverse events version 3.0. Toxicities directly, probably, or possibly related to the radiation were included. Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event (AE) based on this general guideline: Grade 1 Mild Adverse Event Grade 2 Moderate Adverse Event Grade 3 Severe Adverse Event Grade 4 Life-threatening or disabling Adverse Event Grade 5 Death related to Adverse Event
Outcome measures
| Measure |
Intraoperative Radiation Arm
n=71 Participants
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy
|
|---|---|
|
Incidence of Grade 3/4 Toxicity
|
0 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: There were 71 patients who received IORT. Of those 71 patients, 18 received further local therapy due to "high risk" pathology. The results include the 53 patients who received IORT without further local therapy.
Percentage of participants who experienced a ipsilateral breast event (tumor bed recurrence versus elsewhere in breast).
Outcome measures
| Measure |
Intraoperative Radiation Arm
n=53 Participants
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy
|
|---|---|
|
Ipsilateral Breast Recurrence
|
13 percentage of participants
Interval 6.0 to 26.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: No data were collected for any of these biomarkers. Although samples were obtained from patients, they were never processed and analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: No data were collected for this biomarker. Although samples were obtained from patients, they were never processed and analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: No data were collected for this biomarker. Although samples were obtained from patients, they were never processed and analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Intraoperative Radiation Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intraoperative Radiation Arm
n=71 participants at risk
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
surgery: conventional
therapy: neoadjuvant
radiation therapy: intraoperative radiation therapy
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Blood and lymphatic system disorders
Low blood counts
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Reproductive system and breast disorders
Breast pain
|
2.8%
2/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Cardiac disorders
Congestive heart failure (CHF)
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Injury, poisoning and procedural complications
Seroma
|
2.8%
2/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
General disorders
Edema: limb
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
2.8%
2/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Injury, poisoning and procedural complications
Fracture
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Injury, poisoning and procedural complications
Intraoperative breast injury
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Gastrointestinal disorders
Nausea
|
4.2%
3/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Eye disorders
Changes in vision
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Nervous system disorders
Pain - Head/headache
|
1.4%
1/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
|
Infections and infestations
Skin (cellulitis)
|
2.8%
2/71 • Acute toxicity was evaluated 1 week and 3 months after IORT
|
Additional Information
Robin V Johnson
University of North Carolina Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place