This study will evaluate the safety and efficacy of cryoablation therapy combined with
radiation therapy for the relief of pain associated with metastatic bone tumors.
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Full eligibility criteria for NCT01461252
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
18 years of age or older
Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging [e.g. computed tomography
(CT) or magnetic resonance imaging (MRI)] with known (biopsied) primary disease
(primary bone cancer is excluded)
Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10
(pain as bad as subject can imagine) despite pharmaceutical pain management
Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (additional less painful metastatic sites may be present)
• Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, MRI, or ultrasound (US) imaging
Tumors must be suitable for cryoablation
If the primary tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots
Cryoablation should be performed within 14 days of baseline evaluations
Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3
Life expectancy ≥ 2 months
Platelet count >50,000/mm³ within 6 weeks of screening
INR (International Normalized Ratio) <1.5 within 6 weeks of screening
No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
Clinically suitable for cryoablation therapy
Clinically suitable for radiation therapy
Leukemia, lymphoma, and myeloma
Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
Has undergone prior ablation treatment of the index tumor
Has undergone prior radiation therapy of the index tumor < 3 weeks prior to screening
Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava, bowel, or bladder
Surgery at the tumor site or surgery involving the cryoablation-treated tumor
Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
ANC (absolute neutrophil count) <1000 mm3 within 6 weeks of screening
Uncontrolled coagulopathy or bleeding disorders
Currently pregnant, nursing, or wishing to become pregnant during the study
Active, uncontrolled infection
Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to study entry
Concurrent participation in other experimental studies that could affect the primary endpoint
All locations for NCT01461252
View full eligibility
Tris trial is registered with FDA with number: NCT01461252. The sponsor of the trial is Galil Medical and it is looking for 0 volunteers for the current phase.
Official trial title: Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases
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