Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2026
Carbon ion radiotherapy for non-metastatic pancreatic cancer: final results of the prospective phase 2 PACK-study (NCT04194268).
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Liermann Jakob, Naumann Patrick, Jäkel Cornelia, Baumann Lukas, Koczur Beata, Röhrich Manuel, Englert Felix H, Jessen Inga, Tawk Bouchra, Knoll Maximilian, Baltazar Filipa, Harrabi Semi, Springfeld Christoph, Michalski Christoph, Haberkorn Uwe, Mairani Andrea, Abdollahi Amir, Kieser Meinhard, Debus Jürgen, Herfarth Klaus
Аннотация
PURPOSE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.