- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01986829
Cryoablation, Radiofrequency Ablation, or Microwave Ablation in Treating Patients With Metastatic Sarcoma Stable on Chemotherapy
August 23, 2018 updated by: Washington University School of Medicine
Tumor Ablation in Metastatic Sarcoma Stable on Chemotherapy
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment (ablation)
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Other Names:
-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.
-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
-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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: Assessed up to 5 years
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-Defined as time from diagnosis of metastatic disease to the time of death
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Assessed up to 5 years
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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)
|
|
Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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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)
|
|
Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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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)
|
|
Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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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)
|
|
Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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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)
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Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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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)
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Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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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)
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Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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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)
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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.
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Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Brian Van Tine, M.D., Ph.D., Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 3, 2014
Primary Completion (ACTUAL)
August 8, 2017
Study Completion (ACTUAL)
August 8, 2017
Study Registration Dates
First Submitted
November 11, 2013
First Submitted That Met QC Criteria
November 11, 2013
First Posted (ESTIMATE)
November 19, 2013
Study Record Updates
Last Update Posted (ACTUAL)
September 19, 2018
Last Update Submitted That Met QC Criteria
August 23, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201309108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcoma
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-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBone Sarcoma | Retroperitoneal Sarcoma | Adult Soft Tissue SarcomaUnited States
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Mohammed M MilhemGenentech, Inc.CompletedSarcoma | Soft Tissue Sarcoma | Metastatic Sarcoma | Locally Advanced Sarcoma | Unresectable SarcomaUnited States
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-
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David DickensWithdrawnSoft Tissue Sarcoma | Bone Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft-tissue Sarcoma | Metastatic Bone Sarcoma | Unresectable Bone SarcomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
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-
Assiut UniversityNot yet recruitingThyroid Nodule (Benign)
-
The First Affiliated Hospital with Nanjing Medical...Recruiting
-
Karolinska InstitutetRecruitingPortal Hypertension | Splenomegaly; Congestive, Chronic | Panhematopenia; SplenicSweden
-
The First People's Hospital of ChangzhouCompletedColorectal Cancer
-
Qianfoshan HospitalShandong Provincial HospitalNot yet recruitingAdvanced Non Small Cell Lung CancerChina
-
Zagazig UniversityCompletedHepatocellular Carcinoma
-
Chinese University of Hong KongCompletedHepatocellular CarcinomaChina
-
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