Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment with Chemotherapy and Carbon Ions Radiation Therapy (hadrontherapy)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.
详细描述
Enrolled subjects will undergo to 3 cycles of Folfirinox before re-evaluation of the lesion. Then, 4D planning and imaging with respiratory gating end rescanning technique will be adopted to calculate the optimal treatment plan to carbon ions radiation therapy: 38.4 Gy[RBE] is the prescribed dose to CTV. 4.8 Gy[RBE]/fraction will be delivered 4 times a week in two weeks. 4/6 weeks after hadrontherapy, after a CT scan with contrast, patient will undergo to a surgery. After 4/6 weeks, Gemcitabine will be administered for 6 cycles.
Secondary endpoints of the trial are overall survival, resectability rate (operable vs borderline operable), acute toxicity within 3 months, 3-6 months, over 6 months.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologic/cytologic diagnosis of exocrine pancreas tumour
- •resectable or borderline resectable exocrine pancreatic tumour (according to operability criteria)
- •no metastasis from US, CT, PET, MRI or laparotomy
- •Karnofsky index >= 70
- •stomach and duodenum not infiltrated by tumour
- •given informed consent to study procedures
- •Hb > 9 g/dL, N> 1500, PLT> 100000
- •creatininemia < 1.5 mg/dL; bilirubinemia < 1.5 times upper normal values; albumin > 3 g/dL
- •DPD normal activity
- •contraception required and breast feeding not permitted
排除标准
- •non resectable, locally advanced tumours
- •insular cells tumour
- •comorbidities excluding abdominal surgery and/or chemo- radiation therapy
- •known metastasis
- •DPD low activity
- •inability to attend study procedures and follow ups
- •pregnancy
- •previous diagnosis of other tumour with more disadvantageous prognosis then the study object
- •metallic biliary stent
- •metallic prothesis or any other condition to prevent from target volume individuation and dose calculation
- •clinical condition preventing from radiation therapy (i.e. infections in the irradiation area)
- •medical and/or psychical condition preventing from radiation therapy
- •past radiation therapy on abdomen.
研究组 & 干预措施
Preoperatory chemoradiation therapy with carbon ions
Chemoradiation followed by surgery
干预措施: Preoperative chemotherapy (Drug)
Preoperatory chemoradiation therapy with carbon ions
Chemoradiation followed by surgery
干预措施: Preoperative radiotherapy (Radiation)
结局指标
主要结局
Progression free survival
时间窗: The local progression free survival will be assessed at 1-year
The local progression free survival is measured
次要结局
- resectability rate R0 stratified (operable vs not operable)(time of surgery (4-6 weeks after radiotherapy))
- overall survival(The overall survival of enrolled patients will be assessed at 2-years)
- Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity(The incidence of acute and medium term toxicity will be assessed up to 90 and 180 post-operative days respectively. The incidence of late toxicity will be assessed through study completion, an average of 1 year.)
- intra and perioperatory complications(The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days)
研究者
Francesca Valvo
Principal investigator
CNAO National Center of Oncological Hadrontherapy