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Proffered Paper session - Gastrointestinal tumours, non-colorectal

1376O - The effect of hyperthermic intraperitoneal chemotherapy (HIPEC) upon cytoreductive surgery (CRS) in gastric cancer (GC) with synchronous peritoneal metastasis (PM): A randomized multicentre phase III trial (GASTRIPEC-I-trial)


19 Sep 2021


Proffered Paper session - Gastrointestinal tumours, non-colorectal


Management of Systemic Therapy Toxicities;  Cytotoxic Therapy;  Surgical Oncology;  Supportive Care and Symptom Management

Tumour Site

Gastric Cancer


Beate Rau


Annals of Oncology (2021) 32 (suppl_5): S1040-S1075. 10.1016/annonc/annonc708


B. Rau1, H. Lang2, A. Königsrainer3, I. Gockel4, H. Rau5, H. Seeliger6, C. Lerchenmüller7, D. Reim8, R. Wahba9, M. Angele10, S. Heeg11, T. Keck12, A. Weimann13, S. Topp14, P. Piso15, A. Brandl16, E. Trips17, V. Heinemann18, P.C. Thuss-Patience19

Author affiliations

  • 1 Surgery, Universitätsklinik Charité, Campus Virchow Klinikum, 13353 - Berlin/DE
  • 2 Surgery, Johannes Gutenberg Universität Mainz Klinikum, Mainz/DE
  • 3 Surgical Oncology, Universitätsklinikum Tübingen, Tübingen/DE
  • 4 Surgical Oncology, Universitätsklinikum Leipzig, Leipzig/DE
  • 5 Surgery, Amper Kliniken AG, Dachau/DE
  • 6 Surgical Oncology, Charité - Universitätsmedizin Berlin, Berlin/DE
  • 7 Medical Oncology Dept., Gemeinschaftspraxis für Hämatologie und Onkologie - Münster, Münster/DE
  • 8 Surgery, Klinikum rechts der Isar / TU München, München/DE
  • 9 Surgery, University Hospital of Cologne, Köln/DE
  • 10 Surgery, Klinikum der Universität München - Großhadern, München/DE
  • 11 Surgery, Universitätsklinikum Freiburg Klinik für Innere Medizin Hämatologie, Onkologie und Stammzelltransplantation, 79106 - Freiburg im Breisgau/DE
  • 12 Surgery, UKSH Campus Lübeck, Lübeck/DE
  • 13 Surgery, St. Georg-Krankenhaus Leipzig, Leipzig/DE
  • 14 Surgery, Bonifatius Hospital Lingen, Lingen/DE
  • 15 Klinik Für Allgemein- Und Viszeralchirurgie, Barmherzige Brueder Krankenhaus Regensburg, DE-93049 - Regensburg/DE
  • 16 Surgical Oncology, Fundação Champalimaud, Lisbon/PT
  • 17 Koordinierungszentrum Für Klinische Studien Dresden, Technische Universität Dresden, Dresden/DE
  • 18 Medical Oncology Dept. And Comprehensive Cancer Center, LMU - Ludwig Maximilians University - Grosshadern, 81377 - Munich/DE
  • 19 Hematology Oncology Dept., Universitätsklinik Charité, Campus Virchow Klinikum, 13353 - Berlin/DE


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Abstract 1376O


In patients (pts) with PM from GC, palliative chemotherapy (CTx) is the treatment of choice. CRS and HIPEC is still matter of debate, as the evidence is controversial. We conducted a randomized controlled multicentre trial to explore the impact of HIPEC after CRS on overall survival (OS). (Funding German Cancer Aid; ClinicalTrials.gov, number NCT02158988).


Pts with GC and histologically proven PM were randomized to arm CRS alone (with curative intent) (CRS-A) or arm CRS and HIPEC (CRS+H) with pre- and post-operative (op) CTx. CTx was defined as EOX; in case of HER-2 positivity it contained Cisplatin, Capecitabine and Trastuzumab. The HIPEC treatment consisted of Mitomycin C 15 mg/m2 and Cisplatin 75 mg/m2, in 5 litres of saline (60 min, 42 °C). Randomisation was stratified by centre, PCI, and HER2 status. The primary endpoint (EP) was OS, secondary EP progression and other distant metastasis free survival (PFS and MFS). Power analysis computed 180 pts. Analyses followed the intention to treat and time-to-event data by Fleming-Harrington test.


Between 03/2014 and 06/2018 105 pts were randomized (52 pts to CRS+H and 53 pts to CRS-A) and recruitment was stopped due to slow recruitment. In total, 55 pts stopped treatment before CRS (disease progression or death). The median OS for both groups was 14.9 months (CRS-A 14.9 months (95% CI: 7.0-19.4) vs (CRS+H 14.9 months 95% CI: 8.7-17.7; p=0.1647). PFS was significantly improved from 3.5 months (95% CI 3.0-7.0) in the CRS-A group to 7.1 months (95% CI 3.7-10.5; p=0.0472) in the CRS+H group. The CRS+H group showed a better MFS 10.2 months (95% COI: 7.7-14.7) compared to 9.2 months (95% COI: 6.8-11.5; p=0.0286). Pts with grade > 3 adverse events during pre-op CTx and 30 post-op days were similar in both groups (46% and 43.6% in the CRS+H group, 62% and 38.1% in CRS-A group; p=0.160 and p=0.79, respectively).


The study showed no difference in OS in pts treated with CRS ± HIPEC. However, the PFS and MFS were significantly better in the CRS+H group. Therefore, further investigations seem worthwhile. Additional HIPEC did not compromise patient’s safety.

Clinical trial identification

NCT02158988; EudraCT 2006-006088-22.

Editorial acknowledgement

Legal entity responsible for the study

Charité - University of Berlin.


German Cancer Aid.


B. Rau: Other, Institutional, Principal Investigator: German Cancer Aid. H. Lang: Financial Interests, Personal, Advisory Board: Humedics. D. Reim: Other, Personal and Institutional, Research Grant, Clinical Trial: DFK; Other, Personal and Institutional, Principal Investigator, Clinical Trial: TAKEDA. P.C. Thuss-Patience: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Astra-Zeneca; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Servier. All other authors have declared no conflicts of interest.

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