Proton radiation with chemotherapy before surgery for pancreatic cancer
Tests chemotherapy and proton radiation before surgery in adults with borderline resectable pancreatic cancer.
Plain-language title generated from the registry record
Registry title: Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
Key facts
- Where
- Wiener Neustadt, AustriaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which describes how well you can do daily activities?
Source: NCT04894643, who can take part
Where in Austria
- Department of Surgery, LK Wiener NeustadtWiener Neustadt, AustriaTaking people
- EBG MedAustron GmbHWiener Neustadt, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- EBG MedAustron GmbH
- Trial code
- NCT04894643
- Record updated
- 20 March 2026
- Original description
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.Read full original descriptionShow less
Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
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.
Inclusion: 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); Age > 18 years; Karnofsky index ≥ 70; No tumor infiltration of stomach or duodenum; The patient is informed of the diagnosis and is able to give informed consent (Ability of subject to understand character and individual consequences of the study protocol); Women of fertile age must have adequate conception prevention measures and must not breast feed; Signed Informed Consent (must be available before study inclusion).
Exclusion: Previous diagnosis of another neoplasm with worse prognosis as compared with the one in this study; Previous abdominal radiotherapy; Prior systemic treatment for pancreatic cancer; Major medical or psychiatric comorbidities that contraindicate radiation therapy, chemotherapy or surgery; Known allergic/hypersensitivity reaction to any of the components of study treatments; Metallic prosthesis or other condition that prevent an adequate imaging for target volume definition; Loco-regional conditions that contraindicate radiotherapy e.g. active infections in the area; Severe hepatic impairment; Hypersensitivity to PACLitaxel, albumin, gemcitabine or to any of the excipients of the chemotherapy; Baseline Neutrophil Counts < 1.5 x 10\^9/L; Non-exocrine tumors; Presence of distant metastasis; Pregnancy or unwilling to do adequate conception prevention; Lactating and unwilling to discontinue lactation; Men of childbearing potential not willing to use effective means of contraception; Baseline Grade ≥ 2 sensory or motor neuropathy; Patient refusal.