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Proton therapy combo aims to shrink pancreatic tumors before surgery

NCT ID NCT04894643

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Department of Surgery, LK Wiener Neustadt

    RECRUITING

    Wiener Neustadt, 2700, Austria

  • EBG MedAustron GmbH

    RECRUITING

    Wiener Neustadt, Lower Austria, 2700, Austria

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