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Pancreas CancerLAPCNCT05191940

Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)

A study testing Particle-therapy using protons or carbon ions, Blood sampling and Magnetic resonance imaging in people with Pancreas Cancer, run by EBG MedAustron GmbH at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an interventional, single-arm, open-label study with high dose short course radiotherapy for patients with locally advanced pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreas Cancer
What is being tested?
Particle-therapy using protons or carbon ions, Blood sampling and Magnetic resonance imaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteAustria
Study dates
16 May 2022to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has histologically or cytological confirmed diagnosis of pancreatic cancer (cases with radiological findings suspicious of pancreatic cancer AND elevated CA 19-9 may be enrolled even without positive cytology)
  • The patient is not candidate for radical surgical resection because of one or more of the following reasons:
  • the patient is staged as locally advanced and with unresectable disease according to the international consensus definition. Specific criteria are: there is involvement of portal vein/superior mesenteric vein with bilateral narrowing/occlusion, exceeding the inferior border of the duodenum; or tumor contact/invasion of 180 or more degree of the superior mesenteric artery or of the truncus coeliacus; or tumor contact/invasion of the proper hepatic artery/ celiac artery; or tumor contact or invasion of the aorta.
  • the patient is not a candidate for radical surgery because of radiographic or biochemical (CA 19-9) progression during neoadjuvant chemotherapy despite being initially classified as resectable or borderline resectable according to the international consensus definition.
  • the patient is not candidate for radical surgery because of cN+ stage
  • The patient is not candidate to (further) neoadjuvant chemotherapy because of one or more of the following reasons:
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  • the patient is not fit for chemotherapy
  • the patient has progressed under chemotherapy
  • the patient has received neoadjuvant chemotherapy but is judged still not a candidate for explorative surgery.
  • Negative staging for distant metastasis
  • 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 patient 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)

Who cannot join

  • Non-exocrine tumors
  • Major medical or psychiatric comorbidities that contraindicate radiotherapy
  • Presence of distant metastasis
  • Pregnancy or unwilling to do adequate conception prevention
  • Lactating and unwilling to discontinue lactation
  • Men of procreative potential not willing to use effective means of contraception
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  • Metallic prosthesis or other conditions - IF it prevents an adequate imaging for target volume definition or treatment planning at the discretion of the treating institution contraindicate radiotherapy e.g. active infections in the area
  • Previous abdominal radiotherapy
  • Severe hepatic or renal impairment at discretion of treating institution
  • Patient refusal

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Piero Fossati, M.D. contact

+43 664 80878 ext. 408

piero.fossati@medaustron.at

Austria1 site, 1 recruiting

  • EBG MedAustron GmbH

    Wiener Neustadt, Lower Austria, 2700

    Piero Fossati, M.D., +43 2622 26 100 ext. 408, piero.fossati@medaustron.at

    Piero Fossati, M.D.

    Recruiting

Other trials in Austria

About this study

Official title: Phase II Trial of Hypo-fractionated Highly Conformal Radiotherapy for Locally Advanced Pancreatic Carcinomas

This is an interventional, single-arm, open-label study with high dose short course radiotherapy for patients with locally advanced pancreatic cancer.

Read the detailed description

This is an interventional, open label, trial of definitive hypofractionated radiotherapy for patients with locally advanced pancreatic cancer.

Within this study radiotherapy shall be delivered with active scanning particle-therapy using proton- or carbon ions radiotherapy.

Particle therapy will be performed with a simultaneous integrated boost (SIB) treating a larger target volume, including elective lymph node stations and neural plexus, at a lower dose and boosting macroscopic disease.

The investigator will explore the efficacy of these treatment in a real world scenario in which patients are allowed to receive standard systemic treatment and standard surgical treatment (if conversion to resectability is achieved).

However, and in order to record and to gain better understanding of the influence of systemic therapies on the outcomes parameters of this study, patients will be sub-stratified in 3 groups: i) patients receiving FOLFIRINOX, ii) patients receiving Gemcitabine + Nanoparticle Albumin Bound Paclitaxel (NAB-Paclitaxel), iii) patients receiving other systemic therapies or not receiving antineoplastic systemic therapy.

Conditions
Pancreas Cancer
Being tested
Particle-therapy using protons or carbon ions, Blood sampling, Magnetic resonance imaging, Computertomography, 18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)
Keywords
Particle Radiotherapy, Hypofractionated radiotherapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Particle-therapy using protons or carbon ionsRadiation

    According to the radiation plan (between 25 and a maximum of 40 Gy). Planning Target Volume 1 : 25 Gy (Relative Biological Effectiveness) in 5 fractions of 5 Gy (Relative Biological Effectiveness) Planning Target Volume 2 : A simultaneous integrated boost (SIB) will be delivered to the Planning Target Volume 2: 40 Gy (Relative Biological Effectiveness) in 5 fractions of 8 Gy (Relative Biological Effectiveness).

  • Blood samplingDiagnostic test

    Evaluation before treatment-start, after treatment and follow-up period.

  • Magnetic resonance imagingDiagnostic test

    For treatment planning as well as for follow-up radiological tumor assessment.

  • ComputertomographyDiagnostic test

    For treatment planning as well as for follow-up radiological tumor assessment.

  • 18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)Diagnostic test

    For treatment planning as well as for follow-up radiological tumor assessment.

Study groups in NCT05191940
Study groupRoleWhat they receive
Particle radiotherapyOtherAccording to the radiation plan using protons or carbon ions (between 25 and a maximum of 40 Gy). Planning Target Volume 1 : 25 Gy (Relative Biological Effectiveness) in 5 fractions of 5 Gy (Relative Biological Effectiveness) Planning Target Volume 2 : A simultaneous integrated boost (SIB) will be delivered to the Planning Target Volume 2: 40 Gy (Relative Biological Effectiveness) in 5 fractions of 8 Gy (Relative Biological Effectiveness).
Receives: Radiation: Particle-therapy using protons or carbon ions; Diagnostic Test: Blood sampling; Diagnostic Test: Magnetic resonance imaging; Diagnostic Test: Computertomography; Diagnostic Test: 18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Locoregional tumor control

    Rate of locoregional tumor control at two year will be evaluated radiologically.

    This endpoint will be measured with the actuarial approach.

    Measured: At two year

Secondary outcomes (7)

  1. Loco-regional progression-free survival

    This endpoint will be measured with the actuarial approach. It will be assessed as the union of locoregional control and survival. Patient with loco regional recurrence will be considered failures. Deceased patient will also be considered failures. Patient lost to follow-up without evidence of locoregional recurrence will be censored. Distant metastasis and peritoneal carcinosis will be irrelevant respect to this endpoint.

    Measured: 104 weeks after therapy

  2. Overall survival

    This endpoint will be measured with the actuarial approach. All deaths will be considered failures, patient lost to follow-up will be censored.

    Measured: Maximal 109 weeks

  3. Incidence of CTCAE v5.0 G4-5 toxicity

    This endpoint will be scored as gross rate. The investigator will measure the number of patients experiencing at least one toxicity >= Grade 4 and >= Grade 5 and the number of events >= Grade 4 and >= Grade 5. The crude number will be divided by the total number of patients treated.

    Measured: From enrollment to six months after radiation therapy initiation

  4. Patient reported Health-related Quality of Life, measured with Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep)

    Quality of life will be measured with Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) before radiation therapy and at each follow-up. The FACT-Hep has 27 (+ a subscale with 18 additional) questions, each of which is answered using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored. Questions measure the respondents' health state over the last 7 days in four subscales: Physical Well-Being (7 questions), Social/Family Well-Being (7 questions), Emotional Well-Being (6 questions), and Functional Well-being (7 questions). This disease-specific version of the FACT-Hep contain these four core subscales, with additional (18) questions appended to address disease-specific factors.

    The higher the score the better the Quality of Life.

    Measured: Maximal 109 weeks

  5. Patient reported Health-related Quality of Life, measured with European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-C30

    Quality of life will be measured with EORTC Quality of Life Questionnaire-C30 before radiation therapy and at each follow-up.

    Questionnaire developed to assess the quality of life of cancer patients. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: Maximal 109 weeks

  6. Patient reported Health-related Quality of Life, measured with Brief Pain Inventory

    Quality of life will be measured with Brief Pain Inventory before radiation therapy and at each follow-up.

    The Brief Pain Inventory (BPI) is a measurement tool for assessing clinical pain.The interference items were now presented with 0-10 scales, with 0=no interference and 10=interferes completely.

    Measured: Maximal 109 weeks

  7. Incidence of CTCAE v5.0 Grade 2 - Grade 5 acute, subacute and late toxicities

    The number of events, their grade and their time course will be measured.

    Measured: 104 weeks after therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2022
  2. Study start16 May 2022
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05191940
Sponsor's protocol ID
LAPC-MA-092021
Acronym
LAPC
Status last verified
May 2025
First submitted
16 Dec 2021
Last updated
20 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Particle-therapy using protons or carbon ions, Blood sampling and Magnetic resonance imaging in people with Pancreas Cancer, run by EBG MedAustron GmbH at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Piero Fossati, M.D. (+43 664 80878 ext. 408, piero.fossati@medaustron.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Locoregional tumor control (time frame: At two year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05191940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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