NCT01345552已完成不适用
Phase II Study of Stereotactic Radiosurgery for Patients With Oligo-recurrent Disease
Steven Burton2 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2011年6月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Adverse Events Related to Treatment
研究概览
简要总结
This study will evaluate the feasibility of radiosurgery for all metastatic sites in patients presenting with oligometastatic disease, defined here as 5 or fewer sites of metastatic disease involving 3 or fewer organ systems.
详细描述
Death from metastatic cancer is a common cause of death, accounting for 80-90% of cancer deaths. The classic thought process is that metastatic disease represents the continuum such that known metastatic disease is an inevitable harbinger for subsequent metastatic disease. However, it has been reported that a subset of patients with limited volume metastatic disease may have a better prognosis if given aggressive therapy. This group of patients has become known as "oligometastatic". These patients are potentially curable with stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT) (collectively referred to as stereotactic body radiotherapy or SBRT) to the metastatic disease sites in combination with standard curative therapy to the primary site. Patients in this study receive SRS/SBRT to all sites of oligometastatic disease.
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
- •3.1 Conditions for Patient Eligibility
- •3.1.1 Pathologically (histologically or cytologically) proven diagnosis of solid malignancy 3.1.2 Eligible disease sites include the following
- •GI (including colorectal, anal, esophagus, pancreas, gastric with the exception of patients with colon cancer and liver-only metastatic disease )
- •Head and neck
- •Skin (melanoma and squamous cell carcinoma)
- •Lung (both small cell and non-small cell)
- •Sarcoma (both soft tissue and bone)
- •Gynecologic (endometrial, cervical, ovarian, vaginal, vulvar)
- •3.1.3 Patients are stage IV (M1) or recurrent with any combination of T and N with oligometastatic disease as defined by 5 or fewer total sites of metastatic disease 3.1.4 Can have recurrent disease from the primary disease (this is definition of oligorecurrent disease) but cannot have any other primary cancer diagnosed or treated within the last 3 years other than cutaneous skin cancer.
- •3.1.5 Prior systemic chemotherapy is allowable 3.1.4 Zubrod Performance Status 0-1 3.1.5 Age ≥ 18 3.1.6 CBC/differential obtained within 4 weeks prior to registration on study, with adequate bone marrow function defined as follows: 3.1.6.1 Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3; 3.1.6.2 Platelets ≥ 100,000 cells/mm3; 3.1.6.3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.); 3.1.7 Women of childbearing potential and male participants must practice adequate contraception 3.1.8 Patient must provide study specific informed consent prior to study entry
排除标准
- •3.2.1 Ineligible disease sites include the following
- •Multiple myeloma
- •Primary CNS
- •Peritoneal carcinomatosis
- •Colon cancer with liver-only metastatic disease that is treatable with surgical resection 3.2.2 Other
- •Diffuse metastatic spread confined to one organ system is ineligible; examples of this include leptomeningeal spread in the CNS and peritoneal carcinomatosis.
- •Metastatic disease sites must be treatable with stereotactic radiosurgery (at discretion of treating physician). Patients with oligometastatic sites not amenable to SRS treatment, either through size or locations, are ineligible for this trial.
- •3.2.4 Severe, active co-morbidity, defined as follows: 3.2.4.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; 3.2.4.2 Transmural myocardial infarction within the last 6 months; 3.2.4.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; 3.2.4.4 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
- •3.2.5 Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- •3.2.6 Patients unable to have an FDG-PET scan, either through insurance coverage, patient decision or other reason are not eligible for this study.
- •3.2.7 Oligometastatic disease sites not eligible based on concern for toxicity:
- •trachea involvement (direct invasion, tumors close to or abutting trachea are eligible)
- •heart (direct invasion or involvement, pericardial lymph nodes can be treated) 3.2.8 Patients unable to have SRS through insurance coverage or ability to pay for SRS
结局指标
主要结局
Adverse Events Related to Treatment
时间窗: Up to 5 years
Adverse Events as measured by CTCAE version 4.0, possibly, probably or definitely related to study treatment.
次要结局
- Serious Adverse Events related to treatment(Up to 5 years)
- Overall survival (OS)(Up to 5 years)
- Local control of metastatic sites(Up to 5 years)
- Analysis of patterns of failure post-SRS/SBRT(Up to 5 years)
- The Functional Assessment of Cancer Therapy - General (FACT-G)(5 years)
研究者
Steven Burton
Clinical Associate Professor
University of Pittsburgh
研究点 (2)
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