Abstract 1440TiP
Background
Peritoneal relapse is seen in 60-70% of tumors of diffuse type gastric cancer (gc), compared to only 20-30% of intestinal type according to Laurens`s classification. 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 signet ring cell gc patients (pts) before macroscopic peritoneal seeding has happened, 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.
Trial design
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). 3-6 pre-operative cycles of biweekly FLOT are a prerequisite for enrollment (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. The scope of the trial is to evaluate the efficacy as well as the safety and tolerability of the combination of perioperative chemotherapy combined with an intraoperative HIPEC. Primary endpoint is disease free survival, major secondary endpoints are overall survival, perioperative morbidity/mortality including VAS pain score and quality of life as assessed by EORTC QLQ C30 questionnaire. 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 7 patients are recruited.
Clinical trial identification
EudraCT 2017-003832-35; NCT04447352.
Editorial acknowledgement
Legal entity responsible for the study
Krankenhaus Nordwest gGmbH, Frankfurt, Germany.
Funding
Stiftung Deutsche Krebshilfe, Bonn, Germany.
Disclosure
S. Al-Batran: Financial Interests, Personal, Invited Speaker: AIO Studien gGmbH; Financial Interests, Personal, Invited Speaker: Bristol-Myers Squibb; Financial Interests, Personal, Advisory Board: Bristol-Myers Squibb; Financial Interests, Personal, Advisory Board: Immutep; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: MacroGenics; Financial Interests, Personal, Invited Speaker: MCI Deutschland GmbH; Financial Interests, Personal, Advisory Board: MSD Sharp & Dohme; Other, Personal, Other, CEO/founder: Institute of Clinical Cancer Research IKF at Northwest Hospital; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Bristol-Myers Squibb; Financial Interests, Institutional, Research Grant: Celgene; Financial Interests, Institutional, Research Grant: Eurozyto; Financial Interests, Institutional, Research Grant: Federal Ministry of Education and Research; Financial Interests, Institutional, Research Grant: German Cancer Aid (Krebshilfe); Financial Interests, Institutional, Research Grant: German Research Foundation; Financial Interests, Institutional, Research Grant: Hospira; Financial Interests, Institutional, Research Grant: Immutep; Financial Interests, Institutional, Research Grant: Ipsen; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Medac; Financial Interests, Institutional, Research Grant: MSD Sharp & Dohme; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Institutional, Research Grant: Vifor. T.O. Götze: Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board: MSD Oncology; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Invited Speaker: Servier; Non-Financial Interests, Personal and Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Personal and Institutional, Research Grant: Deutsche Forschungsgemeinschaft (DFG); Non-Financial Interests, Personal and Institutional, Research Grant: Deutsche Krebshilfe; Non-Financial Interests, Personal and Institutional, Research Grant: Gemeinsamer Bundesausschuss. All other authors have declared no conflicts of interest.