NCT02542202终止不适用
A Pilot Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Renal Cell Carcinoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity
研究概览
简要总结
This pilot clinical trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with kidney cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.
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
- •Patients must have histologically or cytologically confirmed metastatic or recurrent RCC (any histologic subtype)
- •Patients must have between 1 to 5 new or recurrent lesions suspicious for metastatic RCC on diagnostic imaging
- •Each extracranial lesion must be =< 6 cm and amenable to SBRT or surgical excision
- •Patients must have 3 or fewer brain metastases, of size =< 4 cm
- •Brain metastases must be treated prior to enrollment in the study; the modality of treatment of brain metastases can include surgical resection, whole brain radiotherapy, stereotactic radiosurgery, or any combination of the above
- •Patients who have an intact unresected primary tumor should be considered for radical nephrectomy and primary resection prior to enrollment in the study; if the patient is not eligible for surgical resection, the primary tumor must be amenable to SBRT or request for applications (RFA); generally, this will be defined as a primary tumor < 10 cm in size or a primary lesion which can be treated to a dose of >= 8 Gy x 5 without excessive perceived risk of toxicity
- •Patients must have had at least a computed tomography (CT) of the chest, abdomen, and pelvis within 4 weeks of registration in the trial; CT or magnetic resonance imaging (MRI) of the brain is only required in the presence of neurologic symptoms
- •Patients must have had no radiotherapy, immunotherapy, chemotherapy or therapy with targeted agents within the last 1 month
- •Patients may not have had prior bevacizumab, based on case reports of tracheoesophageal fistula in patients treated with bevacizumab and radiotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status =<2
- •Age 18 years or older
- •Life expectancy of >= 3 months
- •Patients must have normal organ and marrow function within 30 days of registration, as defined below:
- •Absolute neutrophil count >= 500/mcL
- •Hemoglobin >= 8.0 g/dL
- •Platelets >= 50,000/mcL
- •Total bilirubin within normal institutional limits
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal if liver metastases are present
- •Women of childbearing potential must have a negative pregnancy test within 14 days of registration
- •Patients must have the ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients who have had prior chemotherapy, immunotherapy, targeted therapy, or radiotherapy within 1 month of enrollment
- •Patients who have had any prior bevacizumab, due to case reports suggesting a possible risk of severe toxicity in combination with radiotherapy
- •Patients with radiographic or clinical findings of spinal cord compression or cauda equina syndrome with neurologic deficit thought to be due to malignancy
- •Patients may not be receiving any systemic anti-cancer agents or other investigational agents during radiation therapy
- •Patients may not have received prior radiation therapy to a site of recurrence which would require overlap of appreciable radiation dose
- •Known active invasive malignancy except for renal cell carcinoma and/or non-melanoma skin cancer
- •Severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration;
- •Transmural myocardial infarction within the last 6 months prior to registration;
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration;
- •Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease if the liver is involved with metastatic disease;
- •Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
- •Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment
研究组 & 干预措施
Stereotactic body radiation therapy
Experimental
Patients undergo stereotactic body radiation therapy on day 1 over 3 times a week for 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity
时间窗: Up to 1 year
RT-related grade \>= 4 toxicity will be determined on a case-by-case basis by the study group, taking into consideration the region treated with SBRT, timing of the toxicity, and the nature of the toxicity. Rates of RT-related grade \>= 4 toxicity will be recorded, time to RT-related grade \>= 4 toxicity will be recorded, and freedom from RT-related grade \>= 4 toxicity will be determined using the Kaplan-Meier method.
次要结局
- Progression-free Survival(From start of treatment to time of progression, assessed up to 1 year)
- Toxicity Profile of 5-fraction SBRT Based on Normal Tissue Dosimetric Constraints Based on the Organ Site of Involvement(Up to 1 year)
- Treated Lesion Control (LeC)(From the start of treatment to the time of local progression at each treated lesion, assessed up to 1 year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate CancerProstate AdenocarcinomaStage IV Non-Small Cell Lung CancerStage IV Breast CancerStage IV Prostate CancerMale Breast CarcinomaRecurrent Breast CarcinomaRecurrent Non-Small Cell Lung CarcinomaRecurrent Prostate CarcinomaNCT02206334NRG Oncology42
已完成
1 期
Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine CancerRecurrent Endometrial Serous AdenocarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaRecurrent Fallopian Tube CarcinomaNCT03325634University of Colorado, Denver15
已完成
不适用
Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate CancerStage I Prostate AdenocarcinomaStage II Prostate AdenocarcinomaNCT02470897University of Wisconsin, Madison115
进行中（未招募）
早期 1 期
Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung CancerStage II Non-Small Cell Lung Cancer AJCC v7Stage IIB Non-Small Cell Lung Carcinoma AJCC v7Stage IA Non-Small Cell Lung Carcinoma AJCC v7Stage IIA Non-Small Cell Lung Carcinoma AJCC v7Stage IIIA Non-Small Cell Lung Cancer AJCC v7Stage I Non-Small Cell Lung Cancer AJCC v7Stage IB Non-Small Cell Lung Carcinoma AJCC v7NCT03348748Roswell Park Cancer Institute20
撤回
不适用
Stereotactic Radiosurgery Followed by Wedge Resection in Treating Patients With Early Stage Peripheral Non-small Cell Lung CancerStage IA Non-small Cell Lung CancerStage IB Non-small Cell Lung CancerRecurrent Non-small Cell Lung CancerNCT02250378University of Southern California