Particle-based Partial Tumor Irradiation of Unresectable Bulky Tumors

NCT04875871 | Terminated

• 1 other identifier: PATHY-MA-072020
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

Particle Radiotherapy; Partial Tumor Irradiation

Outcome Measures

Primary Outcomes (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.

  11 months (after treatment)

Secondary Outcomes (10)

• Feasibility of PARTICLE-PATHY

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

• Overall survival

  11 months (after treatment)

• Time to local tumor progression

  11 months (after treatment)

• Time to distant tumor progression

  11 months (after treatment)

• Abscopal (distant) tumor response rate

  11 months (after treatment)

Study Arms (2)

High-dose group

EXPERIMENTAL

3 fractions of 12 Gy Relative Biological Effectiveness (RBE)

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 group

EXPERIMENTAL

3 fractions of 8-10 Gy RBE

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

Interventions

Particle radiotherapy RADIATION

Partial radiotherapy targeting the hypoxic tumor segment

High-dose group; Reduced-dose group

Magnetic resonance imaging DIAGNOSTIC_TEST

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

High-dose group; Reduced-dose group

Computertomography DIAGNOSTIC_TEST

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

High-dose group; Reduced-dose group

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.

High-dose group; Reduced-dose group

18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT) DIAGNOSTIC_TEST

For follow-up radiological tumor assessment.

High-dose group; Reduced-dose group

Blood sampling DIAGNOSTIC_TEST

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

High-dose group; Reduced-dose group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• EBG MedAustron GmbH: lead
• Medical University of Vienna: collaborator
• Landesklinkum Wiener Neustadt: collaborator
• Klinik Ottakring: collaborator

Study Sites (1)

EBG MedAustron GmbH

Wiener Neustadt, Lower Austria, 2700, Austria

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Magnetic Resonance Imaging; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Slavisa Tubin, M.D.

  EBG MedAustron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: November 11, 2021
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

AU (1)