Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial) (LAPC)

March 19, 2026 updated by: EBG MedAustron GmbH

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
    • Lower Austria
      • Wiener Neustadt, Lower Austria, Austria, 2700
        • Recruiting
        • EBG MedAustron GmbH
        • Contact:
        • Principal Investigator:
          • Piero Fossati, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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)

  2. The patient is not candidate for radical surgical resection because of one or more of the following reasons:

    1. 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.
    2. 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.
    3. the patient is not candidate for radical surgery because of cN+ stage

  3. The patient is not candidate to (further) neoadjuvant chemotherapy because of one or more of the following reasons:

    1. the patient is not fit for chemotherapy
    2. the patient has progressed under chemotherapy
    3. the patient has received neoadjuvant chemotherapy but is judged still not a candidate for explorative surgery.
  4. Negative staging for distant metastasis
  5. Age > 18 years
  6. Karnofsky index ≥ 70
  7. No tumor infiltration of stomach or duodenum
  8. 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)
  9. Women of fertile age must have adequate conception prevention measures and must not breast feed
  10. Signed Informed Consent (must be available before study inclusion)

Exclusion Criteria:

  1. Non-exocrine tumors
  2. Major medical or psychiatric comorbidities that contraindicate radiotherapy
  3. Presence of distant metastasis
  4. Pregnancy or unwilling to do adequate conception prevention
  5. Lactating and unwilling to discontinue lactation
  6. Men of procreative potential not willing to use effective means of contraception
  7. 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
  8. Previous abdominal radiotherapy
  9. Severe hepatic or renal impairment at discretion of treating institution
  10. Patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Particle radiotherapy
According 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).
Diagnostic test: Magnetic resonance imaging
For treatment planning as well as for follow-up radiological tumor assessment.
Diagnostic test: Computertomography
For treatment planning as well as for follow-up radiological tumor assessment.
Radiation: Particle-therapy using protons or carbon ions
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).
Diagnostic test: Blood sampling
Evaluation before treatment-start, after treatment and follow-up period.
Diagnostic test: 18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)
For treatment planning as well as for follow-up radiological tumor assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional tumor control
Time Frame: At two year

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

This endpoint will be measured with the actuarial approach.
At two year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loco-regional progression-free survival
Time Frame: 104 weeks after therapy
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.
104 weeks after therapy
Overall survival
Time Frame: Maximal 109 weeks
This endpoint will be measured with the actuarial approach. All deaths will be considered failures, patient lost to follow-up will be censored.
Maximal 109 weeks
Incidence of CTCAE v5.0 G4-5 toxicity
Time Frame: From enrollment to six months after radiation therapy initiation
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.
From enrollment to six months after radiation therapy initiation
Patient reported Health-related Quality of Life, measured with Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep)
Time Frame: Maximal 109 weeks

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.
Maximal 109 weeks
Patient reported Health-related Quality of Life, measured with European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-C30
Time Frame: Maximal 109 weeks

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.
Maximal 109 weeks
Patient reported Health-related Quality of Life, measured with Brief Pain Inventory
Time Frame: Maximal 109 weeks

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.
Maximal 109 weeks
Incidence of CTCAE v5.0 Grade 2 - Grade 5 acute, subacute and late toxicities
Time Frame: 104 weeks after therapy
The number of events, their grade and their time course will be measured.
104 weeks after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EBG MedAustron GmbH

Investigators

  • Principal Investigator: Piero Fossati, M.D., EBG MedAustron GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2022

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 16, 2021

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAPC-MA-092021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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