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



Status:Terminated
Healthy:No
Age Range:18 - Any
Updated:12/29/2017
Start Date:December 2014
End Date:October 2016

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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 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"

Inclusion Criteria:

1. Male or female patient is ≥ 18 years old,

2. One to two painful vertebrae (T1-L5) with evidence of osteolytic or mixed lytic and
blastic metastatic lesion by cross sectional imaging and pathologic fracture (presence
of non-painful vertebrae with metastatic lesions in addition to the painful index
vertebrae are allowed)

3. Never received radiation therapy at index level(s) (following consult with radiation
oncologist re: conventional treatment options) OR Received radiation therapy without
adequate relief from metastatic bone pain as determined by the patient and treating
physician, their treating physician would not prescribe additional radiation
treatments, or refuse additional radiation therapy,

4. Brief Pain Inventory (BPI) worst pain score of ≥ 4 (irrespective of medication),

5. Woman of potential childbearing age agrees to a medically effective birth control
method,

6. Life expectancy of ≥ 2 months,

7. Sufficient mental capacity to comply with the protocol requirements,

8. Understands the potential risks and benefits of study participation and is willing to
provide written informed consent.

Exclusion Criteria:

1. Primary tumors of the bone (e.g., osteosarcoma) at site of index vertebra(e),

2. Benign tumors of the bone (e.g. osteoid osteoma) at site of index vertebra (e),

3. Lesions due to hematologic malignancy (e.g. multiple myeloma at site of the index
vertebra (e),

4. Compromise in the posterior column of the vertebral body or walls of pedicles.

5. Extra-osseous extension of metastatic lesion is >10mm,

6. Nonreversible or uncorrectable coagulopathy. INR should not be >1.5,

7. Platelet count of < 50,000 ,

8. Radiation therapy was completed on the index vertebra(e) ≤ 28 days before enrollment,

9. Change in chemotherapy agent is planned 7 days before or after enrollment (change in
dose(s) permitted),

10. Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty,

11. Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index
vertebra(e),

12. Spinal cord compression or canal compromise requiring decompression,

13. Major surgery of the spine in same region as the index vertebra(e) was performed
within 3 months before enrollment,

14. Major elective surgery to the spine in same region as the index vertebra(e) is planned
within 1 month following the ablation and cement procedure,

15. Requires upper and lower limb surgery that will affect functional outcomes,

16. Significant clinical morbidities (aside from the index vertebra(e) and recurrent
cancer) that may interfere with data collection that affects pain and functional
results,

17. Medical/surgical conditions contrary to the kyphoplasty procedure (e.g., presence of
active or incompletely treated local infection, severe pulmonary insufficiency),

18. Bedridden due to paralysis or neurological decline,

19. Currently pregnant or nursing, or planning pregnancy (in the period up to 6 months)
following the index procedure(s),

20. Known allergy to bone cement,

21. Has a heart pacemaker or other electronic device implants

22. Concurrent participation or participation within the last 30 days prior to enrollment
in any clinical trial with an investigational medicinal drug/chemotherapeutic or
biologic or medical product.
We found this trial at
14
sites
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-805-2077
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Alexandria, Virginia 22304
Phone: 703-504-7760
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Phone: 312-926-4251
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Dallas, Texas 75390
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-945-7420
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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La Grange, Illinois 60439
Phone: 708-245-8161
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USC
Los Angeles, California 90033
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Rochester, Minnesota 55905
Phone: 507-293-0988
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4960 Childrens Place
Saint Louis, Missouri 63110
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Salt Lake City, Utah 84124
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Spokane, Washington 99204
Phone: 509-474-4302
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Tampa, Florida 33612
Phone: 813-745-1689
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Torrance, California 90505
Phone: 310-257-5781
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Winston-Salem, North Carolina 27157
Phone: 336-716-0170
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