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โ† Trials
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Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer

RecruitingNAAges 18 Years - anyAllEBG MedAustron GmbH
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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/mmยณ, platelet count \> 100,000 cells/mmยณ, 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 โ‰ฅ 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 โ‰ฅ 2 sensory or motor neuropathy * Patient refusal
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What it tests

  • Proton Ions
  • Nab-PACLitaxel
  • Gemcitabine
  • Capecitabine
  • Surgical resection of the pancreas (when feasible)
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Where

2 sites
EBG MedAustron GmbH
Wiener Neustadt, Austria
Department of Surgery, LK Wiener Neustadt
Wiener Neustadt, Austria
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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