NCT02347618已完成不适用
Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 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
研究组 & 干预措施
Preoperative SBRT
Experimental
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.
干预措施: Preoperative SBRT (Radiation)
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
- Number of Participants with no further growth of cancer at original site (Local control)(2 years)
- Time to Progression of pancreatic cancer(4 years)
- Time to death(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 (1)
Loading locations...
相似试验
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
招募中
2 期
Evaluation of Stereotactic Body Radiotherapy as a Bridge Therapy for Hepatocellular Carcinoma Patients Enlisted for Liver TransplantationHepatocellular CarcinomaNCT06218420Assistance Publique - Hôpitaux de Paris139
终止
1 期
To Evaluate Stereotactic Body Radiotherapy for Treatment of Primary Renal Cell Carcinoma TumorsPrimary TumorRenal Cell CarcinomaNCT02410174Beth Israel Medical Center3
已完成
1 期
SBRT Pre-operatively for Pancreatic CancerPancreatic NeoplasmsNCT02308722University of Oxford12
进行中（未招募）
2 期
SBRT Followed by Neoadjuvant Immunochemotherapy in Resectable Stage II to III Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT05319574Sun Yat-sen University46