Combining proton therapy and chemotherapy for borderline resectable pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial evaluates the feasibility of preoperative chemotherapy combined with proton therapy for patients with borderline resectable pancreatic cancer. Participants will receive gemcitabine and nab-paclitaxel, followed by concomitant proton therapy and capecitabine, before undergoing surgery if feasible. The study aims to assess referral and enrollment procedures, as well as the technical challenges of delivering high doses of proton therapy to complex pancreatic cancer cases. Successful outcomes may lead to a larger study to confirm the effectiveness of this approach in improving surgical resectability and patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• EBG MedAustron GmbH
  Wiener Neustadt, Lower Austria, Austria Recruiting
• Department of Surgery, LK Wiener Neustadt
  Wiener Neustadt, Austria Recruiting

Study contacts

• Principal investigator: Piero Fossati, M.D. — EBG MedAustron GmbH
• Study coordinator: Piero Fossati, M.D.
• Email: piero.fossati@medaustron.at
• Phone: +43 664 80878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.