Cryoablation, Radiofrequency Ablation, or Microwave Ablat... | NCT01986829

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment (ablation)	Experimental	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 Device: Cryoablation Device: Radiofrequency ablation Other: BPI-Short form Other: FACT-G7

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microwave ablation	Device	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.

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Overall Survival (OS)	-Defined as time from diagnosis of metastatic disease to the time of death	Assessed up to 5 years
Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy

Eligibility Module

Eligibility 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.

Name	Affiliation	Role
Brian Van Tine, M.D., Ph.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

PubMed Identifier	Type	Citation	Retractions
29487221	Derived	Hirbe AC, Jennings J, Saad N, Giardina JD, Tao Y, Luo J, Berry S, Toeniskoetter J, Van Tine BA. A Phase II Study of Tumor Ablation in Patients with Metastatic Sarcoma Stable on Chemotherapy. Oncologist. 2018 Jul;23(7):760-e76. doi: 10.1634/theoncologist.2017-0536. Epub 2018 Feb 27.

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 17, 2017

ID	Title	Description
BG000	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)

Units	Counts
Participants	BG0009

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Posted

Count of Participants

Participants

3 months

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG0008

Title

Denominators

Categories

Title	Measurements
	OG0006

Secondary

Overall Survival (OS)

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

Posted

Median

Full Range

months

Assessed up to 5 years

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG0009

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.

-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.

Posted

Count of Participants

Participants

Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

ID	Title	Description
OG000	Pre-treatment	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)
OG001	Post-Treatment	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)

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.

Posted

Count of Participants

Participants

Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

ID	Title	Description
OG000	Pre-treatment	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)
OG001	Post-Treatment	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)

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.

Posted

Count of Participants

Participants

Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

ID	Title	Description
OG000	Pre-treatment	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)
OG001	Post-Treatment

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.

-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.

Posted

Count of Participants

Participants

Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

ID	Title	Description
OG000	Pre-treatment	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)
OG001	Post-Treatment

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.

-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.

Posted

Count of Participants

Participants

Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

ID	Title	Description
OG000	Pre-treatment	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)
OG001	Post-Treatment	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)

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.

Posted

Count of Participants

Participants

Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

ID	Title	Description
OG000	Pre-treatment	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)
OG001	Post-Treatment

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.

Posted

Count of Participants

Participants

Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

ID	Title	Description
OG000	Pre-treatment	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)
OG001	Post-Treatment	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)

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.

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

Posted

Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

ID	Title	Description
OG000	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)

Units	Counts
Participants	OG000

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Intraoperative hemorrhage	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected9 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected9 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected9 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected9 at risk

ID	Term
D012516	Osteosarcoma
D012509	Sarcoma

ID	Term
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D003452	Cryosurgery
D000078703	Radiofrequency Ablation

ID	Term
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative
D000078702	Radiofrequency Therapy
D013812	Therapeutics