Carbon ion radiotherapy as definitive treatment in non-metastasized pancreatic cancer: study protocol of the prospective
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STUDY PROTOCOL
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Carbon ion radiotherapy as definitive treatment in non-metastasized pancreatic cancer: study protocol of the prospective phase II PACK-study Jakob Liermann1,2,3*, Patrick Naumann1,2,3, Adriane Hommertgen1,2,4,5,6, Moritz Pohl7, Meinhard Kieser7, Juergen Debus1,2,3,4,5,6 and Klaus Herfarth1,2,3,4,5,6
Abstract Background: Radiotherapy is known to improve local tumor control in locally advanced pancreatic cancer (LAPC), although there is a lack of convincing data on a potential overall survival benefit of chemoradiotherapy over chemotherapy alone. To improve efficacy of radiotherapy, new approaches need to be evolved. Carbon ion radiotherapy is supposed to be more effective than photon radiotherapy due to a higher relative biological effectiveness (RBE) and due to a steep dose-gradient making dose delivery highly conformal. Methods: The present Phase II PACK-study investigates carbon ion radiotherapy as definitive treatment in LAPC as well as in locally recurrent pancreatic cancer. A total irradiation dose of 48 Gy (RBE) will be delivered in twelve fractions. Concurrent chemotherapy is accepted, if indicated. The primary endpoint is the overall survival rate after 12 months. Secondary endpoints are progression free survival, safety, quality of life and impact on tumor markers CA 19–9 and CEA. A total of twenty-five patients are planned for recruitment over 2 years. Discussion: Recently, Japanese researches could show promising results in a Phase I/II-study evaluating chemoradiotherapy of carbon ion radiotherapy and gemcitabine in LAPC. The present prospective PACK-study investigates the efficacy of carbon ion radiotherapy in pancreatic cancer at Heidelberg Ion Beam Therapy Center (HIT) in Germany. Trial registration: The trial is registered at ClinicalTrials.gov: NCT04194268 (Retrospectively registered on December, 11th 2019). Keywords: Carbon ion radiotherapy, Particle therapy, Pancreatic cancer
Background Pancreatic cancer is a highly lethal cancer. Despite all effort, the five-year overall survival rate is currently at merely 5– 10% [1]. In 2018, the global mortality to incidence ratio was at 94% [2]. So far, operation is the solely curative therapy * Correspondence: [email protected] 1 Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany 2 Heidelberg Institute of Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120 Heidelberg, Germany Full list of author information is available at the end of the article
option but even the postoperative five-year overall survival rate is at only 20% [3]. Often diagnosed in a late stage of disease, approximately one third of all patients initially present with non-metastasized but inoperable locally advanced pancreatic cancer (LAPC) [4]. In the last decades, different neoadjuvant and definitive treatment schemes were evaluated and optimal care is still in discussion. In 2016, Hammel et al. published the prospective, international LAP 07 trial, in which patients u
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