Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Musculoskeletal Diseases

Behaviors and Mental Disorders

Pain

Spinal Cord Neoplasms

Spinal Neoplasms

Quality of Life

Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.

STAR™ Tumor Ablation System

Radiofrequency-targeted vertebral augmentation (RF-TVA)

StabiliT® Vertebral Augmentation System

Jack Jennings, MD

The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.

Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT' and "No Previous RT"

Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)

Evaluation of Targeted Radiofrequency Ablation and Vertebral Augmentation Prior to or Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s) [The STARRT Study]

The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.

Measured by Brief Pain Inventory (BPI) Pain Q3, The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is measuring the mean change from baseline in BPI worst pain score prior to 6 weeks.

The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is the response to Q3 at Weeks 1, 2 and 6.

DFINE Inc.

Merit Medical Systems, Inc.

All cause mortality was collected. Of 35 enrolled subjects, 9 died due to disease progression and 2 died due to other reasons (one was listed as hospice and the other as "unknown"). There were 0 participants considered to have experienced Serious Adverse Events (SAEs) and the participants who died due to disease progression and other reasons are not considered SAEs.

Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.

STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)

StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)

No Previous Radiation Therapy

Failed/Refuse Further Radiation Therapy

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Breast Cancer

Prostate Cancer

Prostate Cancer and Other

Small Cell Lung Cancer

Non-Small Cell Lung Cancer

Thyroid Cancer

Other

Primary Cancer

The BPI asks subjects to rate pain by circling the one number that best describes pain at its worst in the last 24hrs. 0=no pain and 10=pain as bad as (you) can imagine. Results are presented in response to Q3 of the BPI only (i.e. pain at its worst in the last 24hrs). This was accomplished using the BPI short form.

Brief Pain Inventory (BPI -Short Form) - 24 hour worst pain

Study was terminated due to difficulty with enrollment. Analysis of data is limited due to early termination of study and incomplete enrollment and completion of study subjects.

Casey Holland

Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks

Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks

Week 1

Week 2

Week 6

Brief Pain Inventory Q3 Worst Pain Score by Visit

Overall Study

Neoplasm Metastasis

Neoplastic Processes

hypofractionated 12x3 Gy + integrated boost 12x4 Gy

hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT \& hfSRT

hypofractionated, homogeneous radiation (10x3 Gy)

hypofractionated 10x3 Gy

Sabine Semrau, MD

Rainer Fietkau, MD

Spinal metastases indicate for an incurable course of disease. Local tumor control after palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30% of patients, therapy fails locally within two years associated with further symptoms that are difficult to treat, because a further radiation of already radiated vertebra leads to a higher rate of myelitis. This trial aims to improve local tumor control and control of pain by radiotherapy with increase in total and single dose. Dose elevation is realized by simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (IGRT \& hfSRT) and by elevation of elective dose in vertebral body with 12x3 Gy (standard: 10x3 Gy). Primary endpoint is local tumor control (time up to progression). Secondary endpoints are pain control associated with quality of live, severity of acute and chronic adverse effects and overall survival. It is planned to recruit a total number of 155 patients.

Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost

Efficacy of Dose Intensified Radiotherapy of Spinal Metastases of Solid Tumors by Dose Increased, Homogeneous Radiation of Vertebral Body and Simultaneous Application of Stereotactic Boost.

by visual analog scala and questionnaires according pain

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)	NCT02225223	Metastatic Lesi...	STAR™ Tumor Abl... StabiliT® Verte...	18 Years -	Merit Medical Systems, Inc.
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost	NCT01849510	Spinal Metastas...	hypofractionate... hypofractionate...	18 Years -	University of Erlangen-Nürnberg Medical School
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)	NCT02225223	Metastatic Lesi...	STAR™ Tumor Abl... StabiliT® Verte...	18 Years -	Merit Medical Systems, Inc.

Spots Global Cancer Trial Database for vertebral body