Clinical trial NCT02511678: Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases
Official title: Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Neoplasm Metastasis
Bone Metastasis of Diverse Origins
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2015-07-30
Enrollment: 73
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 study will evaluate the efficacy of cryoablation for palliation of painful metastases in participants with metastatic lesions involving bone who have failed, are not candidates for, or are not experiencing adequate pain relief from current pain therapies (for example, radiation, analgesics).

Detailed description: Participants with painful metastatic lesions involving bone who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy were offered enrollment into the study. Participants agreeing to participate will read and sign an informed consent form and thus become participants in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Participants will have one cryoablation procedure and will be followed for up to 6 months for palliation of pain, quality of life, and analgesic usage. Baseline and follow-up data will be collected for each participant via a web-based electronic data collection tool.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Metastatic disease involving bone with metastatic disease previously confirmed by prior biopsy; or Metastatic disease involving bone previously confirmed on imaging (for example, computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) with known (biopsied) primary disease (primary bone cancer is excluded)
* Current analgesic therapies have failed, the participant is not a candidate for, or the participant is not experiencing adequate pain relief from current pain therapies (for example, radiation, analgesics)
* 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 participant can imagine)
* Pain must be from one painful metastatic lesion involving the bone that is amenable to cryoablation with CT (additional less painful metastatic sites may be present)
* Cryoablation should be performed within 14 days of screening visit
* If taking hormonal therapy, use should be stable (no changes within 4 weeks prior to the cryoablation procedure)
* Karnofsky Performance Scale (KPS) score ≥60
* Life expectancy ≥3 months
* No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
* Known coagulopathy or bleeding disorders are controlled

Exclusion Criteria:

* Primary cancer is leukemia, lymphoma, or myeloma
* Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing \>50% loss of cortical bone
* Has undergone prior surgery at the tumor site or the index tumor has undergone previous surgery or ablation treatment
* Prior radiation therapy of the index tumor \<3 weeks prior to the screening visit
* 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 0.5 centimeters (cm) of the spinal cord, brain, other critical nerve structure, or large abdominal vessel (possibly achieved with additional maneuvers such as hydrodissection)
* Index tumor involves the skull
* Currently pregnant, nursing, or wishing to become pregnant during the study
* Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, or cerebrovascular event within 6 months prior to the screening visit
* Concurrent participation in other studies that could affect the primary endpoint

Primary outcomes:
measure: Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants Who Respond to the Cryoablation Therapy
timeFrame: Baseline and Week 8
measure: Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
timeFrame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
measure: Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
timeFrame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
measure: Number of Participants With Additional Pain Therapies
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
measure: Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
timeFrame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
measure: Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
timeFrame: Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24
measure: Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
timeFrame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
measure: Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
measure: Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects
timeFrame: Baseline up to 30 days post-cryoablation
Locations:
city: Los Angeles
country: United States
facility: UCLA Ronald Reagan Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Crittenton Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Bordeaux
country: France
facility: Institut Bergonié
city: Lyon
country: France
facility: Centre Léon Bérard
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Washington University Saint Louis
name: Jack Jennings, MD
role: PRINCIPAL_INVESTIGATOR
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