Proton therapy combo aims to shrink pancreatic tumors before surgery
NCT ID NCT04894643
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new approach for people with borderline resectable pancreatic cancer, where the tumor is close to important blood vessels but may still be removable. Participants first receive chemotherapy, then proton beam radiation combined with more chemo, followed by surgery if possible. The goal is to see if this treatment is safe and helps control the disease before and after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Surgery, LK Wiener Neustadt
RECRUITINGWiener Neustadt, 2700, Austria
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EBG MedAustron GmbH
RECRUITINGWiener Neustadt, Lower Austria, 2700, Austria
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Other studies related to the condition(s) this trial covers.
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- Two oral drugs join chemotherapy in a bid to shrink pancreatic tumors
- Nerve-Block procedure tested against severe pancreatic and stomach cancer pain