Trial Outcomes & Findings for Single Dose Partial Breast Radiotherapy (NCT NCT00944528)
NCT ID: NCT00944528
Last Updated: 2023-10-27
Results Overview
As measured by the incidence of acute toxicity and wound healing complications
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
30 days
Results posted on
2023-10-27
Participant Flow
Participant milestones
| Measure |
Single Dose Radiosurgery: Dose Level 1
A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
Single Dose Radiosurgery: Dose Level 2
A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
Single Dose Radiosurgery: Dose Level 3
A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
16
|
|
Overall Study
COMPLETED
|
8
|
8
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Dose Partial Breast Radiotherapy
Baseline characteristics by cohort
| Measure |
Single Dose Radiosurgery: Dose Level 1
n=8 Participants
A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
Single Dose Radiosurgery: Dose Level 2
n=8 Participants
A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
Single Dose Radiosurgery: Dose Level 3
n=16 Participants
A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
67.2 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Participants receiving all dose levels (8 at 15Gy/Dose level 1, 8 at 18Gy/Dose level 2, 16 at 21Gy/Dose level 3)
As measured by the incidence of acute toxicity and wound healing complications
Outcome measures
| Measure |
Single Dose Radiosurgery: All Dose Levels
n=32 Participants
A single dose of radiation in 15Gy (dose level 1), 18Gy (dose level 2) or 21Gy (dose level 3) given in radiosurgery technique about 10 days before lumpectomy.
|
Single Dose Radiosurgery: Dose Level 2
A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
Single Dose Radiosurgery: Dose Level 3
A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
|---|---|---|---|
|
Maximum Tolerated Dose
|
21 Gray (Gy)
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Participants with a physician's assessment available.
Percent of patients with excellent or good cosmetic outcome at 3 years based on physician's assessment. EXCELLENT is defined as: when compared to the untreated breast or the original appearance of the treated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or seroma within the breast but not enough to change the appearance. GOOD is defined as: there is mild asymmetry between the breasts, which means that there is some acceptable difference in the size or shape of the treated breast as compared to the opposite breast or the appearance of the breast before treatment. There may be some mild reddening or darkening of the breast. The thickening or scar tissue within the breast causes a mild change in its shape or size.
Outcome measures
| Measure |
Single Dose Radiosurgery: All Dose Levels
n=7 Participants
A single dose of radiation in 15Gy (dose level 1), 18Gy (dose level 2) or 21Gy (dose level 3) given in radiosurgery technique about 10 days before lumpectomy.
|
Single Dose Radiosurgery: Dose Level 2
n=6 Participants
A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
Single Dose Radiosurgery: Dose Level 3
n=14 Participants
A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
|---|---|---|---|
|
Cosmetic Outcome
|
71 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Data not collected.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre and post SRS radiosurgeryPre and post-radiotherapy for exploratory analysis of radiation response
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre and post SRS radiosurgeryPre and post-radiotherapy for exploratory analysis of radiation response.
Outcome measures
Outcome data not reported
Adverse Events
Single Dose Radiosurgery: Dose Level 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Single Dose Radiosurgery: Dose Level 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 1 deaths
Single Dose Radiosurgery: Dose Level 3
Serious events: 0 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Dose Radiosurgery: Dose Level 1
n=8 participants at risk
A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
Single Dose Radiosurgery: Dose Level 2
n=8 participants at risk
A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
Note: One participant in dose level 2 was killed in an unrelated motor vehicle accident and was not considered in all-cause mortality.
|
Single Dose Radiosurgery: Dose Level 3
n=16 participants at risk
A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy
|
|---|---|---|---|
|
Cardiac disorders
Chest pain -cardiac
|
0.00%
0/8 • 4 weeks
|
0.00%
0/8 • 4 weeks
|
6.2%
1/16 • 4 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
12.5%
1/8 • 4 weeks
|
12.5%
1/8 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
General disorders
Fatigue
|
0.00%
0/8 • 4 weeks
|
25.0%
2/8 • 4 weeks
|
12.5%
2/16 • 4 weeks
|
|
Infections and infestations
Breast infection
|
0.00%
0/8 • 4 weeks
|
25.0%
2/8 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
Infections and infestations
Infections and infestations-Other
|
0.00%
0/8 • 4 weeks
|
12.5%
1/8 • 4 weeks
|
6.2%
1/16 • 4 weeks
|
|
Infections and infestations
Rash pustular
|
0.00%
0/8 • 4 weeks
|
12.5%
1/8 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
Infections and infestations
Skin infection
|
0.00%
0/8 • 4 weeks
|
12.5%
1/8 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
25.0%
2/8 • 4 weeks
|
50.0%
4/8 • 4 weeks
|
56.2%
9/16 • 4 weeks
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/8 • 4 weeks
|
50.0%
4/8 • 4 weeks
|
50.0%
8/16 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
87.5%
7/8 • 4 weeks
|
87.5%
7/8 • 4 weeks
|
81.2%
13/16 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
12.5%
1/8 • 4 weeks
|
12.5%
1/8 • 4 weeks
|
12.5%
2/16 • 4 weeks
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • 4 weeks
|
0.00%
0/8 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
Reproductive system and breast disorders
Breast atrophy
|
25.0%
2/8 • 4 weeks
|
12.5%
1/8 • 4 weeks
|
18.8%
3/16 • 4 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
50.0%
4/8 • 4 weeks
|
62.5%
5/8 • 4 weeks
|
50.0%
8/16 • 4 weeks
|
|
Reproductive system and breast disorders
Nipple deformity
|
12.5%
1/8 • 4 weeks
|
0.00%
0/8 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders-Other
|
25.0%
2/8 • 4 weeks
|
25.0%
2/8 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • 4 weeks
|
0.00%
0/8 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • 4 weeks
|
0.00%
0/8 • 4 weeks
|
6.2%
1/16 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
12.5%
1/8 • 4 weeks
|
0.00%
0/8 • 4 weeks
|
12.5%
2/16 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
25.0%
2/8 • 4 weeks
|
37.5%
3/8 • 4 weeks
|
25.0%
4/16 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
37.5%
3/8 • 4 weeks
|
12.5%
1/8 • 4 weeks
|
31.2%
5/16 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/8 • 4 weeks
|
25.0%
2/8 • 4 weeks
|
25.0%
4/16 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/8 • 4 weeks
|
12.5%
1/8 • 4 weeks
|
6.2%
1/16 • 4 weeks
|
|
Vascular disorders
Hematoma
|
0.00%
0/8 • 4 weeks
|
0.00%
0/8 • 4 weeks
|
6.2%
1/16 • 4 weeks
|
|
Vascular disorders
Lymphedema
|
25.0%
2/8 • 4 weeks
|
25.0%
2/8 • 4 weeks
|
0.00%
0/16 • 4 weeks
|
Additional Information
Jennifer Mewshaw, MS RN
Assistant Research Practice Manager
Phone: (919) 668-5211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place