Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment with Chemotherapy and Carbon Ions Radiation Therapy (hadrontherapy)

Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.