NCT05191940

Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: EBG MedAustron GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Interventions

Type	Name	Description
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	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	18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)	For treatment planning as well as for follow-up radiological tumor assessment.

Timeline

• Start date: 2022-05-16
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2022-01-14
• Last updated: 2026-03-20

Locations

1 site across 1 country: Austria