NCT04875871

Particle-based Partial Tumor Irradiation of Unresectable Bulky Tumors

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: EBG MedAustron GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
RADIATION	Particle radiotherapy	Partial radiotherapy targeting the hypoxic tumor segment
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.
DIAGNOSTIC_TEST	Copper-64-Diacetyl-bis (N4-methylthiosemicarbazone) Positron Emission Tomography-Computer Tomography (64Cu-ATSM-PET-CT)	For the definition of the hypoxic tumor segment in treatment planning.
DIAGNOSTIC_TEST	18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)	For follow-up radiological tumor assessment.
DIAGNOSTIC_TEST	Blood sampling	Evaluation before treatment-start, during treatment and follow-up period.

Timeline

• Start date: 2021-11-11
• Primary completion: 2025-03-14
• Completion: 2025-03-14
• First posted: 2021-05-06
• Last updated: 2025-05-11

Locations

1 site across 1 country: Austria