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Brief Title: Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)
Official Title: Phase II Trial of Hypo-fractionated Highly Conformal Radiotherapy for Locally Advanced Pancreatic Carcinomas
Study ID: NCT05191940
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
EBG MedAustron GmbH, Wiener Neustadt, Niederösterreich, Austria
Name: Piero Fossati, M.D.
Affiliation: EBG MedAustron GmbH
Role: PRINCIPAL_INVESTIGATOR