Trial Outcomes & Findings for Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis (NCT NCT01527292)

NCT ID: NCT01527292

Last Updated: 2019-02-05

Results Overview

To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

For 6 months post treatment

Results posted on

2019-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only Stereotactic Radiation Therapy: SRT only	Treatment Group Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure SRT with Vertebral Augmentation Procedure: SRT with VAP
Overall Study STARTED	0	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only Stereotactic Radiation Therapy: SRT only	Treatment Group Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure SRT with Vertebral Augmentation Procedure: SRT with VAP
Overall Study Physician Decision	0	3

Baseline Characteristics

Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only Stereotactic Radiation Therapy: SRT only	Treatment Group n=3 Participants Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure SRT with Vertebral Augmentation Procedure: SRT with VAP	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	—	61 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	—	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	3 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: For 6 months post treatment

Population: Data not analyzed due to low enrollment and early termination of study

To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: For 1 year post treatment

Population: Data not analyzed due to low enrollment and early termination of study

To estimate the relative quantitative reduction of pain from baseline in patients in each arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: For 1 year post treatment

Population: Data not analyzed due to low enrollment and early termination of study

To estimate the quality of life using the Oswestry Disability Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: For 1 year post treatment

Population: Data not analyzed due to low enrollment and early termination of study

To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: For 1 year post treatment

Population: Data not analyzed due to low enrollment and early termination of study

To estimate the toxicities of the treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: For 1 year post treatment

Population: Data not analyzed due to low enrollment and early termination of study

To measure the dimensions of the treated vertebra(e) at 1 year

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shiao Woo

University of Louisville, James Graham Brown Cancer Center

Phone: 502-561-2700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place