Journal Article

DKFZ-2026-02618

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Carbon ion radiotherapy for non-metastatic pancreatic cancer: final results of the prospective phase 2 PACK-study (NCT04194268).

Liermann, J. (First author)DKFZ* ; Naumann, P. ; Jäkel, C. ; Baumann, L. ; Koczur, B. ; Röhrich, M. ; Englert, F. H.DKFZ* ; Jessen, I. ; Tawk, B.DKFZ* ; Knoll, M.DKFZ* ; Baltazar, F.DKFZ* ; Harrabi, S. B.DKFZ* ; Springfeld, C.DKFZ* ; Michalski, C. ; Haberkorn, U. ; Mairani, A.DKFZ* ; Abdollahi, A.DKFZ* ; Kieser, M. ; Debus, J.DKFZ* ; Herfarth, K.DKFZ*

2026
Elsevier Science Amsterdam [u.a.]

Abstract: To evaluate the efficacy and safety of carbon ion radiotherapy (CIRT) in patients with non-metastatic, inoperable pancreatic cancer in a prospective phase 2 setting.In this single-center investigator-initiated phase 2 trial, 25 patients with locally advanced or locally recurrent pancreatic cancer were included. CIRT was performed using an intensity-controlled rasterscanning system for beam application [total dose: 48 Gy (RBE), 12 fractions]. Concurrent chemotherapy with Gemcitabine 300 mg/m2 was administered weekly. The primary endpoint was the 1-year OS rate, defined as time from study inclusion. 1y- and 2y-OS and -PFS were calculated using the Kaplan-Meier method, 95 % confidence intervals are shown. Toxicity was evaluated using CTCAEv5.0.Twenty-three patients were included in the final analysis. After the completed 12-month follow-up of the last patient, the 1- and 2-year OS rates were 78 % [CI 63 %; 97 %] and 59 % [CI 41 %; 84 %]. The median OS was 26.5 months. The 1- and 2-year PFS rates were 26 % [CI 13 %; 52 %] and 10 % [CI 3 %; 37 %] with a median PFS of 8.1 months. Study treatment was well tolerated with three treatment-related CTCAE grade 3 toxicities, including one case of abdominal pain, one upper gastrointestinal hemorrhage and one ureteric stricture. No treatment-related CTCAE grade 4-5 toxicities were observed.Chemoradiation with carbon ions demonstrated encouraging overall survival and acceptable toxicity in non-metastatic pancreatic cancer patients. A subsequent randomized Phase 3 trial should investigate OS superiority of CIRT compared to conventional chemoradiotherapy or chemotherapy.

Keyword(s): Carbon ion radiotherapy ; Hypofractionation ; LAPC ; Pancreatic cancer ; Particle therapy

Note: #EA:E050# / #DKTKZFB26# / #NCTZFB26#

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Contributing Institute(s):

1. KKE Strahlentherapie (E050)
2. DKTK HD zentral (HD01)
3. Koordinierungsstelle NCT Heidelberg (HD02)

Research Program(s):

1. 315 - Bildgebung und Radioonkologie (POF4-315) (POF4-315)

Appears in the scientific report 2026

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Database coverage:
; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Ebsco Academic Search ; Essential Science Indicators ; IF >= 5 ; JCR ; Nationallizenz ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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