Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma
Reason given: The study was early closed due to low accrual in August 2022.
Key facts
- Where
- Pavia, ItalySee the site
- Phase
- Phase 2
Where in Italy
- CNAOPavia, ItalyNo longer taking part
Trial details
- Who runs it
- CNAO National Center of Oncological Hadrontherapy
- Trial code
- NCT03822936
- Record updated
- 13 February 2025
- Original description
Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.Read full original descriptionShow less
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.
Inclusion: 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: comorbidities excluding abdominal surgery and/or chemo- radiation therapy; previous diagnosis of other tumour with more disadvantageous prognosis then the study object; past radiation therapy on abdomen; 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; non resectable, locally advanced tumours; insular cells tumour; known metastasis; DPD low activity; inability to attend study procedures and follow ups; pregnancy; metallic biliary stent.