Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EBG MedAustron GmbH
• Collaborator: Landesklinikum Wr. Neustadt
• Treatments: Capecitabine; Gemcitabine; Paclitaxel; Pancrelipase

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

• Lactating and unwilling to discontinue lactation

• Men of childbearing potential not willing to use effective means of contraception

• Known allergic/hypersensitivity reaction to any of the components of study treatments

• Previous diagnosis of another neoplasm with worse prognosis as compared with the one in this study

• 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

• Previous abdominal radiotherapy

• Prior systemic treatment for pancreatic cancer

• Hypersensitivity to PACLitaxel, albumin, gemcitabine or to any of the excipients of the chemotherapy

• Severe hepatic impairment

• Baseline Neutrophil Counts < 1.5 x 10^9/L

• Baseline Grade ≥ 2 sensory or motor neuropathy

• Patient refusal