Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

• Status: Recruiting
• Trial end date: 2023-02-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CNAO National Center of Oncological Hadrontherapy
• Collaborator: Foundation IRCCS San Matteo Hospital
• Treatments: Fluorouracil; Irinotecan; Oxaliplatin; Pancreatin; Pancrelipase

Criteria

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.