Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Pain

Neoplastic Processes

Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only

SRT with Vertebral Augmentation Procedure Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure

Stereotactic Radiation Therapy

SRT with Vertebral Augmentation Procedure

Shiao Y Woo, MD

The purpose of this study is 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.

Eligible Vertebral Metastatic Lesion/s-\> randomized-\> SRT versus SRT+ VAP Stereotactic Radiation Therapy(SRT): 16 Gy X 1 Evaluation: prior to treatment; 1 month, 2-4 months, 5-6 months and 1 year post-treatment

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

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

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

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

To estimate the quality of life using the Oswestry Disability Questionnaire

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

To estimate the toxicities of the treatment

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

James Graham Brown Cancer Center

University of Louisville

Chair-Radiation Oncology

Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only

Stereotactic Radiation Therapy: SRT only

Control 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

Treatment Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Trial did not meet enrollment goal. Investigator did not analyze data due to low enrollment and early termination of trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis	NCT01527292	Vertebral Metas...	Stereotactic Ra... SRT with Verteb...	18 Years -	University of Louisville
Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis	NCT01527292	Vertebral Metas...	Stereotactic Ra... SRT with Verteb...	18 Years -	University of Louisville

Spots Global Cancer Trial Database for srt with vertebral augmentation procedure