A Phase I Study Evaluating the Efficacy and Toxicity of Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Tumor response to SBRT as assessed by FDG-PET/CT
研究概览
简要总结
This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy (SBRT) in treating patients with metastatic or recurrent ovarian cancer or primary peritoneal cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate response of platinum-resistant ovarian cancer to stereotactic body radiation therapy (SBRT) using fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) 3 months after therapy.
II. Determine the rate of grade 3 or greater non-hematologic acute toxicity from SBRT using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
SECONDARY OBJECTIVES:
I. Evaluate response to SBRT using cancer antigen-125 (CA-125) and symptom assessment using Functional Assessment of Cancer Therapy (FACT)-Ovarian Symptom Index (FOSI).
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
- •Patients must have persistent, metastatic, or recurrent platinum resistant or refractory ovarian or primary peritoneal cancer.
- •No restriction on previous treatment regimens, but patients must be at least 2 weeks out from last chemotherapy or investigational agent.
- •Patients must be >=
- •Patients must have a life expectancy of at least 6 months.
- •Patients must have KPS >=
- •Patients must have acceptable organ and marrow function as defined below (within 2 weeks prior to radiotherapy):
- •leukocytes >=3,000/uL
- •absolute neutrophil count >=1,500uL
- •platelets >=100,000/uL
- •total bilirubin within 1.5X normal institutional limits
- •AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- •creatinine within normal institutional limits OR
- •creatinine clearance >=60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- •Patients must be willing to undergo a pre- and post-treatment FDG-PET/CT.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients should not have received radiation overlapping with the proposed treatment field.
- •Patients cannot be receiving chemotherapy or other investigation agents from two weeks prior to radiation through undergoing their post-therapy FDG-PET/CT
- •Patients cannot be pregnant or nursing.
- •Patients cannot have disease >= 8cm or greater than 3 regions of disease.
- •Patients cannot have concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix.
研究组 & 干预措施
Treatment (SBRT)
Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
干预措施: stereotactic body radiation therapy (Radiation)
Treatment (SBRT)
Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
干预措施: positron emission tomography (Procedure)
Treatment (SBRT)
Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
干预措施: computed tomography (Procedure)
Treatment (SBRT)
Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
Treatment (SBRT)
Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity.
干预措施: fludeoxyglucose F 18 (Drug)
结局指标
主要结局
Tumor response to SBRT as assessed by FDG-PET/CT
时间窗: At 3 months
FDG-PET response based on interpretation by nuclear medicine physician with measurement of the maximal standard uptake value (SUV) and identification of new sites of disease. Percentage of decreased SUVmax between the pre- and post-treatment FDG-PET/CT, evaluating means, medians, range and standard deviations.
The rate of grade 3 or greater non-hematologic acute toxicity as graded by the CTCAE v. 4.0
时间窗: 4-6 weeks, and up to 3 months after treatment
Toxicity will be tabulated by type and grade.
次要结局
- Overall survival(Up to 5 years)
- Measure CA-125 level(At baseline; 6 weeks; and 3, 6, and 12 months)
- FACT-Ovarian Symptom Index(At baseline; 6 weeks; and 3, 6, and 12 months)
- Late toxicity and non-grade 3 or greater acute toxicity following SBRT(At 6 weeks; 3, 6, 12, 18 and 24 months)
- Local control(Up to 5 years)
- Progression-free survival(Up to 5 years)
研究者
Elizabeth Kidd
Assistant Professor of Radiation Oncology
Stanford University