NCT02347618已完成不适用
Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Incidence of grade 2 or greater toxicity
研究概览
简要总结
The purpose of this study is to determine whether a short-course of stereotactic body radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and well-tolerated.
详细描述
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.
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
- •Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas
- •CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration
- •CT chest or PET/CT within 6 weeks prior to registration
- •Clinically determined to be resectable based on NCCN Criteria:
- •No radiographic evidence of superior mesenteric vein or portal vein distortion
- •No evidence of distant metastasis
- •Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
- •No enlarged lymph nodes per CT criteria or PET avid lymph nodes
- •No lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy)
- •Adequate cardiopulmonary reserves to tolerate surgery
- •Karnofsky performance status > 70
- •Adequate bone marrow function defined as follows:
- •Absolute neutrophil count (ANC) > 1800 cells/mm3
- •Platelets ≥ 100,000 cells/mm3
- •Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8 g/dl is acceptable.)
- •Pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry
- •Patient must sign study specific informed consent prior to study entry
排除标准
- •Prior surgical resection of any pancreatic malignancy
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- •Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •Severe, active comorbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months
- •Transmural myocardial infarction within the last 6 months
- •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, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure
- •Any evidence of distant metastases (M1)
- •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
结局指标
主要结局
Incidence of grade 2 or greater toxicity
时间窗: 2 years
Number of incidence of grade 2 or greater toxicity
次要结局
- Time to death(4 years)
- Number of Participants with no further growth of cancer at original site (Local control)(2 years)
- Time to Progression of pancreatic cancer(4 years)
- Count subjects with Recurrence of cancer in other body sites(2 years)
研究者
Alan Katz
Associate Professor
University of Rochester
研究点 (2)
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