NCT01986829终止2 期
Tumor Ablation in Metastatic Sarcoma Stable on Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Progression-free Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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)
干预措施: Cryoablation (Device)
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)
干预措施: Microwave ablation (Device)
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)
干预措施: Radiofrequency ablation (Device)
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)
干预措施: BPI-Short form (Other)
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)
干预措施: FACT-G7 (Other)
结局指标
主要结局
Progression-free Rate
时间窗: 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.
次要结局
- Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse(Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation))
- Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea(Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation))
- Overall Survival (OS)(Assessed up to 5 years)
- Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy(Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation))
- Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life(Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation))
- Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well(Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation))
- Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life(Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation))
- Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain(Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation))
- Change in Pain Following Ablation Procedure(Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation))
研究者
研究点 (2)
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