Using HIPEC with chemotherapy before surgery for advanced gastric cancer

A Randomized, Multicenter Clinical Trial Comparing the Combination of Perioperative FLOT Chemotherapy and Preoperative Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Plus Gastrectomy to Perioperative FLOT Chemotherapy and Gastrectomy Alone in Patients With Advanced Gastric Cancer at High Risk of Peritoneal Recurrence

This study is testing if adding a special heated chemotherapy treatment before surgery can help people with advanced stomach cancer avoid cancer returning in their abdomen.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jagiellonian University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Krakow, Lesser Poland Voivodship)
• Trial ID: NCT04597294 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of combining hyperthermic intraperitoneal chemotherapy (HIPEC) with FLOT chemotherapy in patients with advanced gastric cancer who are at high risk for peritoneal metastases. In this randomized, multicenter study, 598 participants will be assigned to receive either HIPEC plus surgery or surgery alone, both followed by additional FLOT chemotherapy. The primary goal is to assess the rate of peritoneal recurrence within six months post-surgery, with long-term follow-up extending to five years to evaluate overall survival and recurrence rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histopathologically confirmed advanced gastric cancer and no distant metastases.

Not a fit: Patients over 75 years old or those with poor general health or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of peritoneal recurrence and improve survival rates for patients with advanced gastric cancer.

How similar studies have performed: Previous studies have shown promising results with HIPEC in various cancers, suggesting potential success for this novel application in gastric cancer.

Eligibility criteria

Inclusion Criteria:

* Gastric cancer confirmed histopathologically in tumor specimens.
* Age 18-75 years.
* Advanced gastric cancer cT3 / cT4a / N0-3b.
* No distant metastases on computed tomography (CT) scan of the chest, abdomen and pelvis (cM0).
* Written consent to participate in the study.

Exclusion Criteria:

* No clear histopathological confirmation of gastric cancer.
* Age \> 75 years.
* Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale).
* Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic).
* Pregnancy and lactation.
* Refusal to participate or an inability to provide written consent.
* Coexisting cancer in another location.
* Systemic treatment or radiotherapy for another cancer.
* Dysphagia requiring surgical treatment (gastric resection or nutritional jejunostomy) before starting neoadjuvant treatment and indication for accelerated surgery for other reasons.
* Disqualification for perioperative FLOT4 chemotherapy as decided by a multi-specialist consultation.

Where this trial is running

Krakow, Lesser Poland Voivodship

• Department of General, Oncological, Gastroenterological Surgery and Transplantology — Krakow, Lesser Poland Voivodship, Poland (RECRUITING)

Study contacts

• Study coordinator: Piotr Richter, Professor

Conditions: Gastric Cancer, HIPEC, FLOT, Gastric cancer, Lymphadenectomy