Actively Recruiting
Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
Led by EBG MedAustron GmbH · Updated on 2026-03-20
10
Participants Needed
2
Research Sites
380 weeks
Total Duration
On this page
Sponsors
E
EBG MedAustron GmbH
Lead Sponsor
L
Landesklinkum Wiener Neustadt
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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/mm8, platelet count > 100,000 cells/mm8, AST and ALT < 2.5 times the upper limit of normal, total bilirubin < 2.5 times the upper limit of normal if recent biliary stenting, total bilirubin < 1.5 times the upper limit of normal if no biliary stenting, serum creatinine within normal range (0.6-1.5 mg/dl) with creatinine clearance > 30 ml/min
- Age > 18 years
- Karnofsky index �3E�3D 70
- No tumor infiltration of stomach or duodenum
- Patient informed of diagnosis and able to give informed consent
- Women of fertile age must have adequate contraception and must not breast feed
- Signed Informed Consent available before inclusion
You will not qualify if you...
- Non-exocrine tumors
- Major medical or psychiatric comorbidities contraindicating radiation, chemotherapy, or surgery
- Presence of distant metastasis
- Pregnancy or unwillingness to use adequate contraception
- Lactating and unwilling to stop lactation
- Men of childbearing potential unwilling to use effective contraception
- Known allergy or hypersensitivity to study treatment components
- Previous diagnosis of another neoplasm with worse prognosis
- Metallic prosthesis or condition preventing adequate imaging for target volume definition
- Loco-regional conditions contraindicating radiotherapy (e.g., active infections)
- Previous abdominal radiotherapy
- Prior systemic treatment for pancreatic cancer
- Hypersensitivity to Paclitaxel, albumin, gemcitabine, or chemotherapy excipients
- Severe liver impairment
- Baseline neutrophil counts < 1.5 x 10^9/L
- Baseline grade �3E�3D 2 sensory or motor neuropathy
- Patient refusal
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
EBG MedAustron GmbH
Wiener Neustadt, Lower Austria, Austria, 2700
Actively Recruiting
2
Department of Surgery, LK Wiener Neustadt
Wiener Neustadt, Austria, 2700
Actively Recruiting
Research Team
P
Piero Fossati, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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