Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery in Pancreatic Adenocarcinoma: A Window of Opportunity Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The feasibility of delivering pre-operative SABR followed by immediate surgery as determined by rate of post-operative complications at 30 days.
研究概览
简要总结
A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.
详细描述
This is a single-centre, prospective, non-randomised feasibility study. This study will assess whether SABR can safely be given immediately prior to Whipple's resection by assessing the rate of post-operative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have given written informed consent to participate in stage 1
- •Be aged 16 years or over at the time of signing the informed consent form
- •Presence of a hypodense pancreatic mass on contrast enhanced CT scan highly suspicious of operable primary pancreatic cancer as assessed by a pancreatic multi-disciplinary team (MDT)
- •Have not had pre-operative systemic therapy or radiotherapy
- •Inclusion Criteria Stage 2:
- •Have participated in stage 1 of the study
- •Have confirmed histological or cytological diagnosis of primary pancreatic adenocarcinoma OR radiological evidence of pancreatic head mass with supportive cytological or histological findings.
- •Be scheduled to undergo pancreatico-duodenectomy (Whipple's) resection.
- •Written informed consent to participate in stage 2
- •Aged 16 years or over at the time of signing informed consent
- •Have not had pre-operative systemic therapy or radiotherapy
- •ECOG Performance status 0-1
- •Adequate renal function: GFR ≥ 60
排除标准
- •Any condition or abnormalities that in the judgement of the investigator/surgeon/clinical oncologist would place the patient at undue risk
- •Women who are known to be pregnant
- •Previous abdominal radiotherapy
- •Women of child-bearing potential who are unwilling to use 2 highly effective forms of contraception during the study treatment period
研究组 & 干预措施
Stereotactic ablative radiotherapy (SABR)
Stereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days.
干预措施: Pre-operative stereotactic ablative body radiotherapy (Radiation)
结局指标
主要结局
The feasibility of delivering pre-operative SABR followed by immediate surgery as determined by rate of post-operative complications at 30 days.
时间窗: Up to 30days post surgery
Rate of post-operative complications measured as the number of adverse events reported up to 30 days post surgery
次要结局
- Measure of disease-free survival post SABR and surgery(1 year)
- Measure of local control post SABR and surgery(1 year)
- Measure of overall survival post SABR and surgery(1 year)
- Measure of surgical resection margin status following pre-operative SABR and immediate surgery(Post surgery)
- Acute and late toxicity of pre-operative SABR: Number of adverse events(1 year)
研究者
CCTU- Cancer Theme
Dr Thankamma Ajithkumar, Consultant Clinical Oncologist
Cambridge University Hospitals NHS Foundation Trust