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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986829
Recruitment Status : Terminated (Slow accrual)
First Posted : November 19, 2013
Results First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Osteosarcoma Sarcoma Device: Microwave ablation Device: Cryoablation Device: Radiofrequency ablation Other: BPI-Short form Other: FACT-G7 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tumor Ablation in Metastatic Sarcoma Stable on Chemotherapy
Actual Study Start Date : February 3, 2014
Actual Primary Completion Date : August 8, 2017
Actual Study Completion Date : August 8, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Device: Microwave 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.

Device: Cryoablation
  • 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.
Other Names:
  • Cryosurgery
  • Cryosurgical ablation

Device: Radiofrequency 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.

Other: BPI-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

Other: FACT-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




Primary Outcome Measures :
  1. Progression-free Rate [ Time Frame: 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 Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Assessed up to 5 years ]
    -Defined as time from diagnosis of metastatic disease to the time of death

  2. Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy [ Time Frame: 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.

  3. Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea [ Time Frame: 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.

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

  5. Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life [ Time Frame: 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.

  6. Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well [ Time Frame: 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.

  7. Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life [ Time Frame: 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.

  8. Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain [ Time Frame: 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.

  9. Change in Pain Following Ablation Procedure [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986829


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Brian Van Tine, M.D., Ph.D. Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01986829    
Other Study ID Numbers: 201309108
First Posted: November 19, 2013    Key Record Dates
Results First Posted: September 19, 2018
Last Update Posted: September 19, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sarcoma
Osteosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue