Hyperthermia European Adjuvant Trial

Phase 3 Unknown 336 enrolled Klinikum der Universitaet Muenchen, Grosshadern Ludwig-Maximilians - University of Munich · collab The European Society for Hyperthermic Oncology · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through an intensified adjuvant treatment with gemcitabine, cisplatin and regional deep hyperthermia as compared to standard chemotherapy.

Timeline

Start: 2012-03
Primary completion: 2019-03
Completion: 2021-03

Outcome

Missed primary endpoint

paper Median DFS was 12.7 compared to 11.2 months for GPH and G, respectively (p = 0.394). PMID 36657324 ↗

paper The randomised controlled Hyperthermia European Adjuvant Trial study failed to demonstrate a significant difference in DFS. PMID 36657324 ↗

Publications

Issels RD, Boeck S, Pelzer U, Mansmann U, Ghadjar P, Lindner LH, Albertsmeier M, Angele MK, Schmidt M, Xu Y, Bahra M, Pratschke J, Schoenberg M, Thasler WE, Salat C, Stoetzer OJ, Knoefel WT, Graf D, Wessalowski R, Keitel-Anselmino V, Koenigsrainer A, Bitzer M, Zips D, Bamberg M, Fietkau R, Ott O, Kawecki M, Wyrwicz L, Rutkowski P, Rentsch M, Ababei J, Reichardt P, Rigamonti M, Weber B, Abdel-Rahman S, Tschoep-Lechner K, Jauch KW, Bruns CJ, Oettle H, von Bergwelt-Baildon M, Heinemann V, Werner J; European Society for Hyperthermic Oncology (ESHO) and the German Arbeitsgemeinschaft Internistische Onkologie (AIO) Study Group for Pancreatic Cancer. Regional hyperthermia with cisplatin added to gemcitabine versus gemcitabine in patients with resected pancreatic ductal adenocarcinoma: The HEAT randomised clinical trial. Eur J Cancer. 2023 Mar;181:155-165. doi: 10.1016/j.ejca.2022.12.009. Epub 2022 Dec 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Capecitabine	Small molecule	1660 mg/m2	Oral
Subject	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Comparator	Gemcitabine	Small molecule	1000 mg/m2	Intravenous