Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Osteosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Hematinics

All Drugs and Chemicals

Liver Extracts

* 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)

* 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.

Microwave ablation

* 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.

Cryoablation

-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.

Radiofrequency ablation

-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

BPI-Short form

FACT-G7

Brian Van Tine, M.D., Ph.D.

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.

Cryoablation, Radiofrequency Ablation, or Microwave Ablation in Treating Patients With Metastatic Sarcoma Stable on Chemotherapy

Tumor Ablation in Metastatic Sarcoma Stable on Chemotherapy

Defined as the percentage of patients with no progression (local recurrence of an ablated lesion or the appearance of a new lesion) after ablation.

-Defined as time from diagnosis of metastatic disease to the time of death

* 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.

* 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.

* 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.

* 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.

* 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.

* 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.

* 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.

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.

Washington University School of Medicine

Treatment (Ablation)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Brian Van Tine, M.D.

Progression-free Rate

Overall Survival (OS)

Pre-treatment

Post-Treatment

Disease Progression

-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.

Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy

Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea

Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse

-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.

Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life

-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.

Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well

Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life

Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain

The data for this outcome measure was not collected as participant's pain was collected via the Fact G7 questionnaire.

Spots Global Cancer Trial Database for Cryoablation, Radiofrequency Ablation, or Microwave Ablation in Treating Patients With Metastatic Sarcoma Stable on Chemotherapy

Trial Identification

Conditions

Interventions

Study Description

Keywords

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