Trial Outcomes & Findings for Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer (NCT NCT01045187)

NCT ID: NCT01045187

Last Updated: 2012-08-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: through completion of radiation therapy
• Results posted on: 2012-08-01

Participant Flow

Recruitment was from September 2008 through October 2009. The centers were at Hospitals and free-standing radiation oncology clinics.

Patients who were candidates for vaginal brachytherapy post TAH-BSO with or without EBRT were enrolled. Patient participation was voluntary for this data collection study.

Participant milestones

Measure	Endometrial Cancer Patients are treated with electronic brachytherapy for an FDA cleared indication.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer

Baseline characteristics by cohort

Measure	Endometrial Cancer n=15 Participants Patients are treated with electronic brachytherapy for an FDA cleared indication.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age Continuous	63.2 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: through completion of radiation therapy

Outcome measures

Measure	Endometrial Cancer n=15 Participants Patients are treated with electronic brachytherapy for an FDA cleared indication.
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System	15 Participants

SECONDARY outcome

Timeframe: through 3 month post treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through 3 month follow up post treatment

Outcome measures

Outcome data not reported

Adverse Events

Endometrial Cancer

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	Endometrial Cancer n=15 participants at risk Patients are treated with electronic brachytherapy for an FDA cleared indication.
Renal and urinary disorders Dysuria	13.3% 2/15 • Number of events 2 • Procedure through 3 month follow-up to report acute toxicities.
Reproductive system and breast disorders Pain	6.7% 1/15 • Number of events 1 • Procedure through 3 month follow-up to report acute toxicities.
Reproductive system and breast disorders Mucosal Atrophy	6.7% 1/15 • Number of events 1 • Procedure through 3 month follow-up to report acute toxicities.
Gastrointestinal disorders Rectal bleeding	6.7% 1/15 • Number of events 1 • Procedure through 3 month follow-up to report acute toxicities.
Reproductive system and breast disorders Vaginal drying	6.7% 1/15 • Number of events 1 • Procedure through 3 month follow-up to report acute toxicities.

Additional Information

Kelly W Elliott RN, MS

Xoft, Inc.

Phone: 408-419-2428

Email: Kelliott@xoftinc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place