Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEBG MedAustron GmbH
About this trial
This is an interventional, single arm, open-label, feasibility trial with gemcitabine and nab-paclitaxel, followed by concomitant proton therapy and capecitabine, followed by re-evaluation and surgery (when feasible) for patients with borderline resectable pancreatic cancer.
Eligibility criteria
Qualifiers
Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer
Diagnosis of borderline resectable cancer according to the international consensus definition 2017.
Negative staging for distant metastasis
Blood test within the following limits absolute neutrophil count > 1,500 cells/mm³, platelet count > 100,000 cells/mm³, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5 times the upper limit of normal, total bilirubin < 2.5 times the upper limit of normal if patient had recent biliary stenting, total bilirubin < 1.5 times the upper limit of normal if no biliary stenting was done, serum creatinine within normal range (0.6-1.5 mg/dl) with a creatinine clearance > 30 ml/min (as estimated by Cockroft Gault equation)
Disqualifiers
Non-exocrine tumors
Major medical or psychiatric comorbidities that contraindicate radiation therapy, chemotherapy or surgery
Presence of distant metastasis
Pregnancy or unwilling to do adequate conception prevention
Trial design
Treatments tested in this trial
- Proton Ions
- Nab-PACLitaxel
- Gemcitabine
- Capecitabine
- Surgical resection of the pancreas (when feasible)
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
EBG MedAustron GmbH
Lead sponsor
Landesklinkum Wiener Neustadt
Collaborator
Source ClinicalTrials.gov