Abstract
BackgroundThe 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 pts. 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.MethodsThis is a multicenter, randomized, controlled, open-label study including a total of 200 pts. with localized and locally advanced diffuse or mixed type (Laurens’s classification) adenocarcinoma of the stomach and Type II/III GEJ.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 (control arm) or surgery + intraoperative HIPEC (cisplatin 75 mg/m2 solution administered at a temperature of 42 °C for 90 min) and postoperative FLOT (experimental arm). Surgery is carried out as gastrectomy or transhiatal extended gastrectomy. Primary endpoint is PFS/DFS, major secondary endpoints are OS, rate of pts. with peritoneal relapse at 2 and 3 years, perioperative morbidity/mortality and quality of life.The trial starts with a safety run-in phase. After 20 pts. had curatively intended resection in Arm B, an interim safety analysis is performed.Recruitment has already started and first patient in was on January 18th, 2021.DiscussionIf the PREVENT concept proves to be effective, this could potentially lead to a new standard of therapy. On the contrary, if the outcome is negative, pts. with gastric cancer and no peritoneal involvement will not be treated with HIPEC during surgery.Trial registrationThe study is registered on June 25th, 2020 under ClinicalTrials.gov Identifier: NCT04447352; EudraCT: 2017-003832-35.
Highlights
The main reason for treatment failure after curative surgical resection of gastric cancer is intraabdominal spread, with 40–50% peritoneal seeding as primary localization of recurrence
Sample size calculation The primary efficacy analysis will compare randomized surgical resection combined with Hyperthermic IntraPEritoneal Chemoperfusion (HIPEC) to randomized surgical resection only on the time to the primary efficacy endpoint using the intent-to-treat population
Fujimoto et al [21] recruited 141 patients and showed that HIPEC significantly reduced the incidence of peritoneal recurrence (p < 0.001) and increased the survival rate (p = 0.03) without a significant increase in postoperative adverse events
Summary
This is a multicenter, randomized, controlled, open-label study including a total of 200 pts. with localized and locally advanced diffuse or mixed type (Laurens’s classification) adenocarcinoma of the stomach and Type II/III GEJ. This is a multicenter, randomized, controlled, open-label study including a total of 200 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 (control arm) or surgery + intraoperative HIPEC (cisplatin 75 mg/m2 solution administered at a temperature of 42 °C for 90 min) and postoperative FLOT (experimental arm). Primary endpoint is PFS/DFS, major secondary endpoints are OS, rate of pts. The trial starts with a safety run-in phase. Had curatively intended resection in Arm B, an interim safety analysis is performed. Recruitment has already started and first patient in was on January 18th, 2021
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