Trial Outcomes & Findings for Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer (NCT NCT01851772)

NCT ID: NCT01851772

Last Updated: 2021-01-12

Results Overview

Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3 participants
• Primary outcome timeframe: Study Exit (90 days)
• Results posted on: 2021-01-12

Participant Flow

Participant milestones

Measure	Treatment Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer

Baseline characteristics by cohort

Measure	Treatment n=3 Participants Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45.67 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Study Exit (90 days)

Population: Diagnosis of locally advanced cervical cancer (Stages Ib2-IVA).

Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.

Outcome measures

Measure	Treatment n=3 Participants Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
Safety - Adverse Event Rate and Severity diarrhea-mild	100 percentage of participants and severity
Safety - Adverse Event Rate and Severity fatigue-mild	100 percentage of participants and severity
Safety - Adverse Event Rate and Severity hot flashes-moderate	100 percentage of participants and severity
Safety - Adverse Event Rate and Severity urinary track infection-mild	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity vaginal bleeding-mild	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity decreased neutrophils-mild	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity insomnia-mild	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity loss of appetite-mild	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity extremity weakness-mild	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity mucositis-mild	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity urinary frequency-mild	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity weight loss-mild	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity headache-moderate	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity chest pressure-moderate	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity light headed-moderate	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity mild skin erythema-mild	33.3 percentage of participants and severity
Safety - Adverse Event Rate and Severity occasional burning with urination-mild	33.3 percentage of participants and severity

SECONDARY outcome

Timeframe: Study Exit (90 days)

Number of subjects who received complete delivery of the brachytherapy treatment using the Xoft Electronic Brachytherapy System with the cervical applicator.

Outcome measures

Measure	Treatment n=3 Participants Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
Device Performance	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months post-Study Exit

To assess occurrence rate of radiation toxicities through three (3) months of follow-up.

Outcome measures

Measure	Treatment n=3 Participants Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
Frequency of Adverse Events in Participants (i.e.Safety)	3 participants

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=3 participants at risk Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
Gastrointestinal disorders Diarrhea	100.0% 3/3 • Number of events 3 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
General disorders Fatigue	100.0% 3/3 • Number of events 3 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
General disorders Hoareseness	33.3% 1/3 • Number of events 1 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
General disorders Hot Flashes	100.0% 3/3 • Number of events 3 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
Infections and infestations Infection	33.3% 1/3 • Number of events 1 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
Reproductive system and breast disorders Vaginal Bleeding	33.3% 1/3 • Number of events 1 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • Number of events 1 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
General disorders Fever	66.7% 2/3 • Number of events 2 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
General disorders Insomnia	33.3% 1/3 • Number of events 1 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
Infections and infestations Mucositis	33.3% 1/3 • Number of events 1 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
Cardiac disorders Chest Pressure	33.3% 1/3 • Number of events 1 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • Number of events 1 • The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.

Additional Information

Crystal Leonard, CCRP

Xoft, Inc.

Phone: 9375038588

Email: cleonard@icadmed.com

Results disclosure agreements

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

Restriction type: LTE60