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CancerPARTICLE-PATHYNCT04875871

Particle-based Partial Tumor Irradiation of Unresectable Bulky Tumors

A study testing Particle radiotherapy, Magnetic resonance imaging and Computertomography in people with Cancer, run by EBG MedAustron GmbH at 1 site in Austria.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study uses a novel, recently developed unconventional radiotherapy technique which consists of three high-dose fractions directed to special segments of unresectable bulky tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Particle radiotherapy, Magnetic resonance imaging and Computertomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteAustria
Study dates
11 Nov 2021to 14 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • Written informed consent obtained from the patient prior to performing any treatment-related procedures.
  • Biopsy proven malignant unresectable solid bulky primary or recurrent tumor (diameter of at least 6 cm or greater, except for the Central Nervous System (CNS) tumors), or in a case of lack of recent biopsy progression on at least two consecutive radiological examinations, with biopsy proof in the past. Presence of locally advanced (cN+) and/or metastatic disease will be accepted in order to allow for assessment of the abscopal effects.
  • Ineligibility for standard treatments including surgery, conventional (whole tumor) radiotherapy and systemic therapy, or being in progression or stable (with no response to systemic treatment) under systemic therapy.
  • A minimum time interval from last dose of systemic therapy before radiotherapy of two weeks; Systemic therapy may be resumed 4 weeks following radiotherapy in order to permit assessment of the treatment efficacy.
  • Median life expectancy of >2 months.
  • Age > 18 years.
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  • Adequate bone marrow function as follows below: Haemoglobin ≥ 8.0 g/d; Absolute neutrophil count (ANC) ≥ 1.5 x 10ꝰ/L (> 1500 per mm3); Platelet count ≥ 100 x 10ꝰ/L (>100,000 per mm3).
  • Female patients must either be of non-reproductive potential (i.e. post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) OR women of fertile age must have adequate conception prevention measures and must have a negative serum pregnancy test upon study entry.
  • Patient is willing and able to comply with the follow up including scheduled visits and examinations.

Who cannot join

  • Patients without bulky lesions.
  • Tumors suitable for the standard therapies including surgery, conventional (whole tumor) irradiation and systemic therapies.
  • Median life expectancy of less than 2 months.
  • Contraindication to i.v. Computer Tomography and Magnetic Resonance Tomography contrast medium administration, particularly estimated glomerular filtration rate (GFR) less than 45 mL/min/1.73 m2.
  • History of autoimmune disease.
  • Current or prior use of immunosuppressive medication within 14 days before enrollment with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
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  • History of primary immunodeficiency.
  • History of allogeneic organ transplant.
  • Uncontrolled intercurrent comorbidity including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, active bleeding diatheses including any patient known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent.
  • Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results. (Note: criterion will be evaluated on the four eyes principle, evaluated by both Principle Investigator and Sub-Investigators.)
  • Patients with uncontrolled seizures.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • EBG MedAustron GmbH

    Wiener Neustadt, Lower Austria, 2700

Other trials in Austria

About this study

Official title: Particle-based Partial Tumor Irradiation Targeting Hypoxic Segment and Sparing the Peritumoral Immune Microenvironment for Unresectable Bulky Tumors

This study uses a novel, recently developed unconventional radiotherapy technique which consists of three high-dose fractions directed to special segments of unresectable bulky tumors.

Read the detailed description

This is a mono-centric, prospective, two-arms, feasibility study in which the investigator will enroll up to 22 patients with locally advanced or metastatic cancers with at least one bulky (≥6cm) lesion. This study uses a novel, recently developed unconventional radiotherapy technique, consisting of a short course (3 fractions) high dose partial irradiation targeting exclusively the hypoxic segment of unresectable bulky tumors while sparing the peritumoral immune microenvironment for induction of immune-mediated tumoricidal bystander and abscopal effects.

The present study will explore the potential biological and physical advantages of particle-based radiotherapy to deliver a highly conformal radiation dose to the hypoxic tumor segment defined by using hypoxia-specific Copper-64-Diacetyl-bis (N4-methylthiosemicarbazone) Positron Emission Tomography-Computer Tomography (64Cu-ATSM PET-CT) and dynamic contrast enhanced Magnetic Resonance Tomography imaging. Based on tumor location, volume and risk factors related to nearby organs at risk, patients will be divided in the "high-dose" or "reduced-dose" group which will be treated with different dose-schedules according to risk factors.

Additionally, radiotherapy will be administered at the precise timing, determined individually for each patient, based on the serially mapped homeostatic immune fluctuations by monitoring blood levels of the inflammatory markers. The objective is to synchronize the radiation treatment with the favorable, most reactive anti-tumor immune response phase, in order to break tumor´s immune-tolerance locally and systemically.

Conditions
Cancer
Being tested
Particle radiotherapy, Magnetic resonance imaging, Computertomography, Copper-64-Diacetyl-bis (N4-methylthiosemicarbazone) Positron Emission Tomography-Computer Tomography (64Cu-ATSM-PET-CT), 18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)
Keywords
Particle Radiotherapy, Partial Tumor Irradiation
Medical subject headings
Neoplasms

What participants receive

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

  • Particle radiotherapyRadiation

    Partial radiotherapy targeting the hypoxic tumor segment

  • 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.

  • Copper-64-Diacetyl-bis (N4-methylthiosemicarbazone) Positron Emission Tomography-Computer Tomography (64Cu-ATSM-PET-CT)Diagnostic test

    For the definition of the hypoxic tumor segment in treatment planning.

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

    For follow-up radiological tumor assessment.

  • Blood samplingDiagnostic test

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

Study groups in NCT04875871
Study groupRoleWhat they receive
High-dose groupExperimental3 fractions of 12 Gy Relative Biological Effectiveness (RBE)
Receives: Radiation: Particle radiotherapy; Diagnostic Test: Magnetic resonance imaging; Diagnostic Test: Computertomography; Diagnostic Test: Copper-64-Diacetyl-bis (N4-methylthiosemicarbazone) Positron Emission Tomography-Computer Tomography (64Cu-ATSM-PET-CT); Diagnostic Test: 18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT); Diagnostic Test: Blood sampling
Reduced-dose groupExperimental3 fractions of 8-10 Gy RBE
Receives: Radiation: Particle radiotherapy; Diagnostic Test: Magnetic resonance imaging; Diagnostic Test: Computertomography; Diagnostic Test: Copper-64-Diacetyl-bis (N4-methylthiosemicarbazone) Positron Emission Tomography-Computer Tomography (64Cu-ATSM-PET-CT); Diagnostic Test: 18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT); Diagnostic Test: Blood sampling

What is being measured

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

  1. Bystander (local) tumor response rate

    Bystander (local, at the level of the partially treated bulky tumor) response rate defined as at least a 30% regression of the unirradiated tumor tissue.

    Measured: 11 months (after treatment)

Secondary outcomes (10)

  1. Feasibility of PARTICLE-PATHY

    Feasibility of patient recruitment, treatment and follow-up rates.

    Measured: 3,5 years (recruiting time + treatment time + 11 months follow-up)

  2. Overall survival

    Defined as the time from treatment until the time of death from any cause.

    Measured: 11 months (after treatment)

  3. Time to local tumor progression

    Defined as the time from treatment until the time of local disease progression.

    Measured: 11 months (after treatment)

  4. Time to distant tumor progression

    Defined as the time from treatment until the time of distant disease progression.

    Measured: 11 months (after treatment)

  5. Abscopal (distant) tumor response rate

    Defined as the proportion of metastatic patients that exhibited an abscopal effect versus the total number of metastatic patients allocated to the treatment.

    Measured: 11 months (after treatment)

  6. Symptoms relief

    Proportion of patients who will achieve a partial or complete relief at different time-points.

    Measured: 11 months (after treatment)

  7. Radiation related toxicity

    Toxicity assessment according to NCI CTCAE v5.0

    Measured: 11 months (after treatment)

  8. Feasibility of timing of PARTICLE-PATHY and its relation to clinical outcomes

    The feasibility of PARTICLE-PATHY and to it related TIMING will be defined by the proportion of patients allocated to this treatment who received it within dosimetric constraints after being able to define the immune-cycle periodicity and to synchronize radiotherapy with it versus the total number of patients allocated to the treatment.

    Measured: Until 11 months after treatment

  9. Bystander/abscopal response rate in relation to dose-size of Peritumoral Immune Microenvironment (PIM)

    See title

    Measured: 11 months (after treatment)

  10. Bystander/abscopal response rate in relation to Interleukin-2 and Interferon Gamma values

    Two key cytokines, Interleukin-2 (IL-2) and Interferon Gamma (INFg), will be serially assessed at baseline and after each radiotherapy treatment, in order to determine their potential role in modulating the immune response in relation to the bystander/abscopal effects.

    Measured: 11 months (after treatment)

Timeline

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

  1. First posted6 May 2021
  2. Study start11 Nov 2021
  3. Primary completion14 Mar 2025
  4. Study completion14 Mar 2025

Why it stopped: targeted patient enrollment was not met.

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875871
Sponsor's protocol ID
PATHY-MA-072020
Acronym
PARTICLE-PATHY
Status last verified
May 2025
First submitted
3 May 2021
Last updated
11 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Particle radiotherapy, Magnetic resonance imaging and Computertomography in people with 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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 11 May 2025. 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?

The study was stopped early (reason given: targeted patient enrollment was not met.). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bystander (local) tumor response rate (time frame: 11 months (after treatment)). 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 NCT04875871.

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 11 May 2025.

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