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

Sarcoma Clinical Trial

Official title:

Tumor Ablation in Metastatic Sarcoma Stable on Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01986829
• Other study ID #: 201309108
• Status: Terminated
• Phase: Phase 2
• Start date: February 3, 2014
• Est. completion date: August 8, 2017

Study information

• Verified date: August 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 8, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteosarcoma
• Sarcoma

Intervention

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.
• 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.
• 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
• 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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 months
Secondary	Overall Survival (OS)	-Defined as time from diagnosis of metastatic disease to the time of death	Assessed up to 5 years
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.	Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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.	Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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.	Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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.	Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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.	Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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.	Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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.	Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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.	Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine