Interventional Multicentric Study Without Medicine, in Patients Affected by Locally Advanced Pancreatic Adenocarcinoma: Stereotactic Radiotherapy.
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Clinical response to the treatment in terms of resectability
研究概览
简要总结
Evaluation of clinical response in terms of resectability of patients with locally advanced pancreatic cancer treated with neoadjuvant chemotherapy plus stereotactic body radiotherapy.
详细描述
Aim of the study is to define the percentage of patients with down-staging and clinical response after having undergone stereotactic radiotherapy + chemotherapy with neoadjuvant intent for locally advanced pancreatic carcinoma or "borderline resectable" at the time of diagnosis.
The study evaluates the response to therapy in terms of resectability, of acute and delayed treatment-related toxicity, of overall survival and progression-free survival and also assesses patient's quality of life.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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
- •histological diagnosis of locally advanced pancreatic carcinoma, not upfront surgically treated (according to NCCN resectability criteria), without distant metastases
- •NCCN criteria resectability status
- •patient's age, performance status, possible presence of comorbidity should also be considered to decide the optimal approach (upfront surgery versus neoadjuvant treatment).
- •If the chemotherapy treatment induces the disease to a condition of resectability, the patient will undergo a surgical evaluation
- •indication for radiotherapy treatment
- •obtaining informed consent
- •not pregnant or breastfeeding
排除标准
- •presence of internal diseases for which radiotherapy is contraindicated, or diseases of the connective system, or gastric or duodenal ulcer in progress or acute diverticulitis, ulcerative colitis
- •comorbidity which in the opinion of the referring physician may constitute a risk for participation in the study
- •lack of availability for clinical-instrumental follow-up
- •previous abdominal radiotherapy.
研究组 & 干预措施
SBRT plus chemotherapy
Patients with unresectable or "borderline resectable" locally advanced pancreatic carcinoma at time of diagnosis
干预措施: SBRT plus chemotherapy (Radiation)
结局指标
主要结局
Clinical response to the treatment in terms of resectability
时间窗: 24 months
Percentage of patients with pancreatic cancer judged to be inoperable who have undergone surgical treatment after neoadjuvant chemotherapy plus stereotactic body radiotherapy. Response is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria) by a multidisciplinary team of surgeons, radiologist, oncologist, radiation oncologist according to resectability criteria NCCN v. 2017.
次要结局
- Overall survival(24 months)
- Progression free survival(24 months)
- Toxicity(24 months)
- Quality of life(24 months)
研究者
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna