Clinical trial NCT01767935: Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases
Official title: A Pilot Study of The Tandem Treatment of Painful Osseous Metastases With Cryoablation Followed by Radiation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bone Metastases
Pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Endocare, Inc.
First posted: 2013-01-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot clinical trial studies cryosurgery and radiation therapy in treating patients with painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Giving cryosurgery together with radiation therapy may kill more tumor cells

Detailed description: PRIMARY OBJECTIVES:

I. To assess the potential for efficacy and safety of combining percutaneous computed tomography (CT)-guided cryoablation and radiotherapy for the palliation of osseous metastases.

OUTLINE:

Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 24 hours and weeks 1-2, 4, 12, 18, and 24.

Eligibility criteria: Inclusion Criteria:

* Pathologically (histologically or cytologically) confirmed metastatic disease with a new tumor involving or abutting bone that has the clinical and imaging features of metastatic disease

  * If the nature of the metastatic disease has been previously documented, index tumor to be treated does not require further documentation (i.e., biopsy)
* Current analgesic therapies have failed (worst pain of 4 or above as measured by Brief Pain Inventory \[BPI\], despite analgesic therapy) OR the subject is experiencing intolerable side effects that preclude analgesic use (resulting in pain of 4 or above, as measured by BPI)
* Pain must be from one or two painful metastatic sites in the bone (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, magnetic resonance imaging (MRI), or ultrasound (US) imaging
  * Metastatic tumors must be amenable to cryoablation with CT or MRI
* If the index tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots
* Patients must have stable use of hormonal therapy for two weeks prior to study registration and two weeks prior to cryoablation procedure)
* Stable use of pain medications (no changes within two weeks of cryoablation procedure)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy \>= 2 months
* Platelets \> 50,000/mm\^3
* International normalized ratio (INR) \>= 1.5
* Patients may not have any debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
* Patients who are taking antiplatelet or anticoagulation medication (e.g., aspirin, ibuprofen, low molecular weight heparin \[LMWH\] preparations) must be able to discontinue such treatment prior to the cryoablation procedure for an appropriate amount of time; at least 5 days should be allowed after discontinuation of aspirin, Coumadin, clopidogrel, and dipyridamole; at least 12 hours should be allowed after discontinuation of LMWH preparations
* Patients must be clinically suitable for cryoablation therapy
* Patients must be clinically suitable for radiation therapy
* Patients must be able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* Patients with a diagnosis of leukemia, lymphoma, or myeloma
* Patients with a tumor involving a weight-bearing long bone of the lower extremity with the tumor causing \> 50% loss of cortical bone
* Patients who have undergone prior ablation treatment or radiation therapy of the index tumor
* Patients who have received chemotherapy within 14 days prior to and 14 days after cryoablation procedure
* Index tumor(s) causing clinical or radiographic evidence of spinal cord or cauda equine 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 (IVC), bowel, or bladder
* Any prior surgery at the proposed treatment site OR any prior surgery involving the cryoablation-treated tumor
* Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
* Patients with uncontrolled coagulopathy or bleeding disorders
* Patients who are pregnant, nursing, or who wish to become pregnant during the study
* Patients with active, uncontrolled infection
* Patients with serious medical illnesses, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within six months prior to study entry
* Patients who are concurrently participating in any other experimental studies that could affect the primary endpoint of this study

Primary outcomes:
measure: Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Medication Level, Assessed by Changes in Narcotic Medication Usage
timeFrame: Baseline to 24 weeks
measure: Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
timeFrame: Up to 24 weeks
measure: Pain After Cryosurgery, as Measured by the BPI
timeFrame: Up to 24 weeks
measure: Number of Participants Who Survived
timeFrame: Up to 24 weeks post-cryosurgery
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: David Childs
role: PRINCIPAL_INVESTIGATOR
References: