Trial Outcomes & Findings for Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation (NCT NCT00571987)

Results Overview

A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

107 participants

Primary outcome timeframe

Margins assessed at Final Pathology, approximately 1 week post-RF surgery

Results posted on

2015-11-24

Participant Flow

The first subject was consented to the study in September 2004. The final subject was consented in March 2010. A total of 107 subjects were consented.

As part of this non-blinded and non-randomized study all participants receive ablation.

Participant milestones

Participant milestones
Measure	Subjects Received RFA Treatment AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
Overall Study STARTED	107
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RFA Treatment n=107 Participants AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
Age, Continuous	65.02 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Margins assessed at Final Pathology, approximately 1 week post-RF surgery

A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.

Outcome measures

Outcome measures
Measure	Margin Status n=100 Participants AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
Number of Patients Requiring 2nd Surgery for Close or Positive Margins	22 participants

SECONDARY outcome

Timeframe: Until study end (2 years)

Population: During the 68-month median follow-up in patients not treated with XRT, there were 2 in-site tumor recurrences treated with AI, 3 biopsy entrance site recurrences treated with excision and XRT to conserve the breast, and 2 recurrences elsewhere and 1 contralateral recurrence; all 3 treated with mastectomy.

Outcome measures

Outcome measures
Measure	Margin Status n=100 Participants AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
Recurrence of Breast Cancer at Prior Site of Disease	2 participants

Adverse Events

RFA Treatment

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RFA Treatment n=107 participants at risk AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
Skin and subcutaneous tissue disorders Wound complication	8.4% 9/107 • Number of events 9 • 2 years

Additional Information

Dr. Suzanne Klimberg

UAMS

Phone: 501-686-6504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place