Status:
TERMINATED
Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma
Lead Sponsor:
CNAO National Center of Oncological Hadrontherapy
Collaborating Sponsors:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Cancer of Pancreas
Pancreas Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.
Detailed Description
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...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03822936
Start Date
February 8 2018
End Date
February 10 2025
Last Update
February 13 2025
Active Locations (1)
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1
CNAO
Pavia, Pavia, Italy, 27100