Osteosarcoma, Sarcoma
Conditions
Brief summary
This phase II trial studies how well cryoablation, radiofrequency ablation, or microwave ablation works in treating patients with metastatic sarcoma stable on chemotherapy. Cryoablation kills tumor cells by freezing them. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Microwave ablation kills tumor cells by heating them to several degrees above body temperature.
Interventions
DEVICEMicrowave ablation
* Microwave ablation will be predominantly used on metastatic soft tissue lesions and will include use of Covidien's Evident™ MWA System. Microwave ablation is performed under ultrasound, CT, and occasional fluoroscopic guidance with CT fluoroscopy available for intermittent use in probe placement and CT monitoring of ablation. * Microwave antennae from Covidien (Mansfield, MA) are either introduced into the lesion co-axially through a bone biopsy needle or directly into the lesions that are amenable to such, i.e., soft tissue, lung, liver, and large lytic lesions with extensive bone destruction.
DEVICECryoablation
* Cryoablation is performed under ultrasound, CT and occasional fluoroscopic guidance with CT fluoroscopy available for intermittent use in cyroprobe placement and CT monitoring of ablation. * Cryoprobes from Endocare Inc. (Irvine CA) or Galil Medical (Arden Hills MN) are either introduced into the lesion co-axially through a bone biopsy needle or directly into the lesions that are amenable to such, i.e., soft tissue, lung, liver, and large lytic lesions with extensive bone destruction.
DEVICERadiofrequency ablation
-Radiofrequency ablation will be predominantly used on metastatic spine lesions and will include use of the Dfine STAR ablation probe. This probe will be placed coaxially through an introducer needle into the spinal metastatic lesion.
OTHERBPI-Short form
-Prior to ablation, 1 day post-ablation, 1 month post-ablation (from first procedure if more than 1 is done), and time of disease progression
OTHERFACT-G7
-Prior to ablation, 1 day post-ablation, 1 month post-ablation (from first procedure if more than 1 is done), and time of disease progression
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed high-grade metastatic sarcoma that has been stable on 6-12 cycles of one chemotherapeutic regimen (cytotoxic or biologic) although a change in chemotherapy is allowed if it is a result of toxicity/tolerability rather than progression. A patient must not have evidence of progression at any time while on chemotherapy in order to be eligible for this trial. * Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with CT scan, PET CT, or MRI exam. * At least 18 years of age. * ECOG performance status ≤ 2 (Karnofsky ≥60%) * Normal bone marrow and organ function as defined below: * Leukocytes ≥ 3,000/mcL * Absolute neutrophil count ≥ 1,500/mcl * Platelets ≥ 100,000/mcl * Total bilirubin ≤ 1.5 x IULN or 3x IULN with normal ALT and AST in patients with Gilbert's disease * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN * Creatinine less than the institutional upper limit of normal OR creatinine clearance ≥ 50 mL/min/1.73 m2 * INR\<1.5 or patient off Coumadin at the time of ablation * No more than 10 treatable lesions as evaluated by an experienced interventional oncologic radiologist for eligibility and lesion accessibility as the ablation of more than 10 lesions becomes technically infeasible. These lesions must be treated in a two- to three-week time period from initial interventional radiology evaluation. Lung and liver lesions can range from 1 cm to 7 cm for a single lesion and no greater than 5 cm for multiple lesions. There are no size criteria for the osseous lesions. * The lesions will be amenable to a safe, ultrasound/computed tomographic/fluoroscopic guided percutaneous approach. The targeted metastases must be sufficiently separable from the central nervous system, major peripheral motor nerves, bowel, and bladder. All lesions must be amenable to treatment. * If patients have received radiation therapy, there must be a one-month washout period. * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of ablation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Patient (or legally authorized representative if applicable) must be able to understand and willing to sign an IRB approved written informed consent document.
Exclusion criteria
* History of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only, carcinoma in situ of the cervix, or localized prostate cancer. * Receiving any other investigational agents simultaneously or within 3 weeks following ablation procedure. * Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant and/or breastfeeding. * Patients whose treatment plans include continuing chemotherapy after ablation as per the treating physician, as ablation therapy is meant to serve as maintenance therapy in lieu of chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Rate | 3 months | Defined as the percentage of patients with no progression (local recurrence of an ablated lesion or the appearance of a new lesion) after ablation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation) | * Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I have a lack of energy * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small. |
| Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation) | * Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I have nausea * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small. |
| Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation) | * Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I worry that my condition will get worse * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small. |
| Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation) | * Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I am able to enjoy life * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small. |
| Overall Survival (OS) | Assessed up to 5 years | -Defined as time from diagnosis of metastatic disease to the time of death |
| Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation) | * Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I am content with the quality of my life right now * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small. |
| Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation) | * Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I have pain * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small. |
| Change in Pain Following Ablation Procedure | Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation) | Measured using the Brief Pain Inventory. Final assessment at time of disease progression. Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean BPI scores between any two times. All analyses will be two-sided at a significance level of 0.05. |
| Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation) | * Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I am sleeping well * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small. |
Countries
United States
Participant flow
Recruitment details
The study opened to participant enrollment on 02/03/2014 and closed to participant enrollment on 06/19/2017.
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Ablation) * Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion.
* Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7) | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Treatment (Ablation) |
|---|---|
| Age, Continuous | 56 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 9 |
| other Total, other adverse events | 1 / 9 |
| serious Total, serious adverse events | 3 / 9 |
Outcome results
Primary
Progression-free Rate
Defined as the percentage of patients with no progression (local recurrence of an ablated lesion or the appearance of a new lesion) after ablation.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Ablation) | Progression-free Rate | 6 Participants |
Secondary
Change in Pain Following Ablation Procedure
Measured using the Brief Pain Inventory. Final assessment at time of disease progression. Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean BPI scores between any two times. All analyses will be two-sided at a significance level of 0.05.
Time frame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
Population: The data for this outcome measure was not collected as participant's pain was collected via the Fact G7 questionnaire.
Secondary
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I am able to enjoy life * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Time frame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
Population: -2 participants were not evaluable for the outcome measure as they did not complete the surveys. 1 participant did not complete this question on the survey at pre-treatment. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Quite a bit (score = 3) | 1 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Somewhat (score = 2) | 3 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Not at all (score = 0) | 0 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | A little bit (score = 1) | 0 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Very much (score = 4) | 2 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Somewhat (score = 2) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Not at all (score = 0) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | A little bit (score = 1) | 2 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Quite a bit (score = 3) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Very much (score = 4) | 5 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Very much (score = 4) | 2 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Quite a bit (score = 3) | 2 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Not at all (score = 0) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | Somewhat (score = 2) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life | A little bit (score = 1) | 0 Participants |
Secondary
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I am sleeping well * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Time frame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
Population: -2 participants were not evaluable for the outcome measure as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Quite a bit (score = 3) | 1 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Somewhat (score = 2) | 2 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Not at all (score = 0) | 0 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | A little bit (score = 1) | 2 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Very much (score = 4) | 2 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Somewhat (score = 2) | 3 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Not at all (score = 0) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | A little bit (score = 1) | 2 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Quite a bit (score = 3) | 1 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Very much (score = 4) | 1 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Very much (score = 4) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Quite a bit (score = 3) | 1 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Not at all (score = 0) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | Somewhat (score = 2) | 1 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well | A little bit (score = 1) | 2 Participants |
Secondary
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I am content with the quality of my life right now * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Time frame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
Population: -2 participants were not evaluable for the outcome measure as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Quite a bit (score = 3) | 5 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Somewhat (score = 2) | 1 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Not at all (score = 0) | 0 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | A little bit (score = 1) | 1 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Very much (score = 4) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Somewhat (score = 2) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Not at all (score = 0) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | A little bit (score = 1) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Quite a bit (score = 3) | 4 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Very much (score = 4) | 3 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Very much (score = 4) | 1 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Quite a bit (score = 3) | 3 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Not at all (score = 0) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | Somewhat (score = 2) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life | A little bit (score = 1) | 0 Participants |
Secondary
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I have a lack of energy * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Time frame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
Population: -2 participants were not evaluable for the outcome measures as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Quite a bit (score = 3) | 1 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Somewhat (score = 2) | 2 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Not at all (score = 0) | 0 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | A little bit (score = 1) | 2 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Very much (score = 4) | 2 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Somewhat (score = 2) | 3 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Not at all (score = 0) | 2 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | A little bit (score = 1) | 1 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Quite a bit (score = 3) | 1 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Very much (score = 4) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Very much (score = 4) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Quite a bit (score = 3) | 1 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Not at all (score = 0) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | Somewhat (score = 2) | 1 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy | A little bit (score = 1) | 2 Participants |
Secondary
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I have nausea * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Time frame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
Population: -2 participants were not evaluable for the outcome measures as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Quite a bit (score = 3) | 0 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Somewhat (score = 2) | 1 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Not at all (score = 0) | 5 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | A little bit (score = 1) | 1 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Very much (score = 4) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Somewhat (score = 2) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Not at all (score = 0) | 6 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | A little bit (score = 1) | 1 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Quite a bit (score = 3) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Very much (score = 4) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Very much (score = 4) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Quite a bit (score = 3) | 1 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Not at all (score = 0) | 2 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | Somewhat (score = 2) | 1 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea | A little bit (score = 1) | 0 Participants |
Secondary
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I have pain * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Time frame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
Population: -2 participants were not evaluable for the outcome measure as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Not at all (score = 0) | 2 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Quite a bit (score = 3) | 0 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Somewhat (score = 2) | 0 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Very much (score = 4) | 0 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | A little bit (score = 1) | 5 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Very much (score = 4) | 2 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Not at all (score = 0) | 2 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | A little bit (score = 1) | 1 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Somewhat (score = 2) | 2 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Quite a bit (score = 3) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | A little bit (score = 1) | 3 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Very much (score = 4) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Quite a bit (score = 3) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Not at all (score = 0) | 1 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain | Somewhat (score = 2) | 0 Participants |
Secondary
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse
* Measured with the FACT-G7 validated survey. Final assessment at time of disease progression. * The question participant was asked was I worry that my condition will get worse * 7 questions about quality of life with answers that range from 0=not at all to 4 = very much * Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small.
Time frame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
Population: -2 participants were not evaluable for the outcome measures as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Quite a bit (score = 3) | 0 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Somewhat (score = 2) | 1 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Not at all (score = 0) | 3 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | A little bit (score = 1) | 2 Participants |
| Treatment (Ablation) | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Very much (score = 4) | 1 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Somewhat (score = 2) | 0 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Not at all (score = 0) | 2 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | A little bit (score = 1) | 4 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Quite a bit (score = 3) | 1 Participants |
| Post-Treatment | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Very much (score = 4) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Very much (score = 4) | 1 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Quite a bit (score = 3) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Not at all (score = 0) | 0 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | Somewhat (score = 2) | 1 Participants |
| Disease Progression | Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse | A little bit (score = 1) | 2 Participants |
Secondary
Overall Survival (OS)
-Defined as time from diagnosis of metastatic disease to the time of death
Time frame: Assessed up to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Ablation) | Overall Survival (OS) | 23.6 months |