Preventive HIPEC in combination with perioperative FLOT versus FLOT alone for resectable diffuse type gastric and gastroesophageal junction type II/III adenocarcinoma: The phase III “PREVENT” trial of the AIO /CAOGI /ACO.

Authors

null

Thorsten Oliver Goetze

University Cancer Center Frankfurt, Institut für Klinisch-Onkologische Forschung and Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, Frankfurt, Germany

Thorsten Oliver Goetze , Pompiliu Piso , Sylvie Lorenzen , Ulli Simone Bankstahl , Marcin Ostrzyzek , Claudia Pauligk , Timursah Habibzade , Daniel Reim , Wolf Otto Bechstein , Alfred Königsrainer , Stefan Paul Mönig , Beate Rau , Matthias Schwarzbach , Salah-Eddin Al-Batran

Organizations

University Cancer Center Frankfurt, Institut für Klinisch-Onkologische Forschung and Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, Frankfurt, Germany, Department for General and Visceral Surgery, Hospital Barmherzige Brueder, University of Regensburg, Regensburg, Germany, Third Department of Internal Medicine (Hematology/Medical Oncology), Klinikum Rechts der Isar, Technische Universitaet Muenchen, Muenchen, Germany, University Cancer Center Frankfurt, Institut für Klinisch-Onkologische Forschung am Krankenhaus Nordwest, Frankfurt, Germany, Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, Frankfurt, Germany, Institute of Clinical Cancer Research (IKF) GmbH at Krankenhaus Nordwest, Frankfurt, Germany, Institute of Clinical Cancer Research, Krankenhaus Nordwest, UCT University Cancer Center, Frankfurt Am Main, Germany, Klinik und Poliklinik für Chirurgie, Klinikum rechts der Isar, Technische Universität München, Munich, Germany, Department of General and Visceral Surgery, University Hospital Frankfurt, Frankfurt, Germany, Department of General-, Visceral Surgery and Transplantation, University Hospital Tuebingen, Tuebingen, Germany, University Hospital Geneva, Geneva, Switzerland, Charite Campus Mitte University of Berlin, Berlin, Germany, Klinikum Frankfurt-Höchst, Department of General, Visceral, Vascular and Thoracic Surgery, Frankfurt, Germany

Research Funding

Other Foundation
Deutsche Krebshilfe

Background: The main reason for treatment failure after curative surgical resection of gastric cancer is intra-abdominal spread, with 40- 50% peritoneal seeding as primary localization of recurrence. Peritoneal relapse is seen in 60-70% of tumors of diffuse type, compared to only 20-30% of intestinal type. Hyperthermic IntraPEritoneal Chemoperfusion (HIPEC) is an increasingly used therapy method for patients with peritoneal metastases. The preventive use of HIPEC could represent an elegant approach for patients (pts) before macroscopic peritoneal seeding, since patients with operable disease are fit and may have potential risk of microscopic involvement, thus having a theoretical chance of cure with HIPEC even without the need for cytoreduction. No results from a PCRT from the Western hemisphere have yet been published. Methods: This is a multicenter, randomized, controlled, open-label study including a total of 200 pts with localized and locally advanced diffuse and mixed type (Laurens`s classification) adenocarcinoma of the stomach and Type II/III GEJ (i.e. ≥cT3 any N or any T N positive). All enrolled pts will have received 3-6 pre-operative cycles of biweekly FLOT (Docetaxel 50 mg/m²; Oxaliplatin 85 mg/m²; Leucovorin 200 mg/m²; 5-FU 2600 mg/m², q2wk). Pts will be randomized 1:1 to receive surgery only and postoperative FLOT (Arm A- Control arm) or surgery + intraoperative HIPEC (cisplatin 75mg/m2 solution administered at a temperature of 42°C for 90 minutes) and postoperative FLOT (Arm B- experimental arm). Surgery is carried out as gastrectomy or transhiatal extended gastrectomy. Primary endpoint is PFS/DFS, major secondary endpoints are OS, R0 resection rate, perioperative morbidity/mortality including VAS pain score and quality of life as assessed by EORTC QLQ C30 questionnaire. The trial starts with a safety run-in phase. After 20 patients had curatively intended resection in Arm B, an interim safety analysis is performed assessing feasibility, safety, and tolerability in Arm B. First patient was randomized on 18JAN2021. Currently one patient is recruited. EudraCT: 2017-003832-35; ClinicalTrials.gov ID: NCT04447352. Clinical trial information: NCT04447352

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT04447352

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr TPS4149)

DOI

10.1200/JCO.2021.39.15_suppl.TPS4149

Abstract #

TPS4149

Poster Bd #

Online Only

Abstract Disclosures