NCT04894643 Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer

Eligibility & Interventions

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This trial targets 10 participants in total. It began in 2020-09-14 with a primary completion date of 2026-12-31.

Brief 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.

Eligibility 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

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