A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Acute Toxicity Rate
研究概览
简要总结
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This clinical trial studies stereotactic radiosurgery using CyberKnife works in treating women with advanced or recurrent gynecological malignancies.
详细描述
PRIMARY OBJECTIVES:
I. The primary goal of this study is to estimate the rate of grade 3 or higher acute toxicities observed during a 6 month period following CyberKnife radiosurgery for gynecologic cancers.
II. To evaluate clinical response to radio-surgery for gynecologic tumors.
III. To assess general and site specific quality of life (using SF-12, FACT-En, FACT-O, FACT-Cx or FACT-V) and to evaluate patient's level of pain.
SECONDARY OBJECTIVES:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven gynecologic malignancy
- •No prior cryosurgery or radiofrequency ablation, in target lesion
- •Patient is able to give and sign study specific informed consent
- •Measurable disease, according to RECIST criteria
- •Laboratory parameters and appropriate clearance from anesthesia based on other medical co-morbidities for placement of fiducials; these would include CBC, basic metabolic panel, BUN, and creatinine
- •>= 4 weeks from previous treatment (chemotherapy or radiation) of malignancy
- •ECOG performance status of 0-3 as this procedure is minimally invasive and considered palliative in these patients
- •Any patient with active connective tissue disease such as lupus or dermatomyositis is excluded
- •Any patient with active Crohn's disease or active ulcerative colitis is excluded
- •Major medical or psychiatric illness, which would prevent completion of treatment or interfere with follow-up is excluded
排除标准
- 未提供
研究组 & 干预措施
Arm I: CyberKnife Radiosurgery
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
干预措施: stereotactic radiosurgery (Radiation)
Arm I: CyberKnife Radiosurgery
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Acute Toxicity Rate
时间窗: at 6 months after treatment
The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.
次要结局
- Quality of Life(After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.)
- Median Overall Survival(24 months)
- Disease-free Survival(completion of study at 24 months)
- Clinical Response Rate(at 6 months from study entry)