Stereotactic Body Radiotherapy [SBRT] for High Risk Localised Pancreatic Cancer: a Phase II Study of the Department of Radiation Oncology Royal North Shore Hospital (Span-C - SBRT for Pancreatic Cancer)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- freedom of local failure
研究概览
简要总结
To assess the freedom from local failure at 12 months after Stereotactic Body Radiotherapy (SBRT). Also to assess the safety, efficacy and feasibility of SBRT in the treatment of high risk localised pancreatic cancer.
详细描述
Patients must have histologically or cytologically confirmed high risk localised adenocarcinoma of the pancreas, including patients with extrapancreatic extension (Stage IIA), node positive (Stage IIB), borderline resectable or locally advanced pancreatic cancer as defined by Australasian Gastro-Intestinal Trials Group (AGITG) guidelines. ECOG performance status 0-1, suitable for chemotherapy and radiotherapy.
After a minimum of 2 months of neoadjuvant chemotherapy using either an oxaliplatin- based regimen (FOLFOX, FOLFIRINOX, mFOLFIRINOX)+/- immunotherapy/molecular agent or gemcitabine based chemotherapy (eg gemcitabine / gemcitabine/abraxane). Participants will receive SBRT (30-45Gray in 5 fractions over 2 weeks. Prior to SBRT, fiducial markers will be placed to aid with image guidance during radiation delivery. Four weeks after completion of SBRT participants will have re-staging using positron emission tomography (PET) and computed tomography (CT) scan. Participants will be discussed in the multidisciplinary team meeting for consideration of surgery. Those considered to be resectable will proceed to have surgery 6-10 weeks post SBRT.
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
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and able to give informed consent
- •Patients with histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas, including patients with extrapancreatic extension (Stage IIA), node positive (Stage IIB), borderline resectable or locally advanced as defined by AGITG guidelines
- •ECOG performance status 0-1
- •Measurable disease as defined by RECIST 1.1
- •Have received or plan to receive chemotherapy
- •Successful insertion of fiducial markers
排除标准
- •Patients with metastatic pancreas cancer
- •Prior abdominal radiotherapy
- •Active malignancy excluding non melanomatous skin cancer
- •Neuroendocrine pancreatic carcinoma
- •Pregnant or lactating women
- •Tumour size greater then 70mm
研究组 & 干预措施
Stereotactic Body Radiotherapy (SBRT)
Prior to SBRT, fiducial markers will be placed to aid with image guidance during radiation delivery. Fiducials will be inserted endoscopically (preferable) or intraoperatively. After this procedure, patients will have radiotherapy planning. During treatment, the fiducials will be used for registration with the images acquired during treatment (including kV fluoroscopy, MV or optical). The acquired images may be processed to determine fiducial location using KIM or MATT software from University of Sydney. SBRT 30-45Gray in 5 fractions will be given over 2 weeks.
Four weeks after completion of SBRT participants will repeat a re-staging PET and CT scans. Those considered to be resectable will proceed to have surgery 6-10 weeks post SBRT.
干预措施: Stereotactic Body Radiotherapy (SBRT) (Radiation)
结局指标
主要结局
freedom of local failure
时间窗: 12 months from end of radiotherapy
patient who do no have local failure
次要结局
- progression free survival (PFS)(12 months after treatment)
- Response to neoadjuvant treatments(from date of surgery through to 24 months post surgery)
- Incidence of SBRT treatment related adverse events in this group of patients(Acute toxicity-from start of SBRT up to 3 months after SBRT. Late RT toxicity: from 3 months to 2 years after SBRT.)
- Feasibility of internal-external correlation model (MATT)(during SBRT radiotherapy treatment)
- median overall survival (OS)(12 months after treatment)
- Surgical complications(30 to 90 days post surgery)
- Duration of hospital admission after surgery(from date of surgery through study completion (ie 24 months))
- margin negative (R0) resection rate(through study completion, average of 2 years)
- Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motion(during SBRT radiotherapy treatment)