Clinical trial NCT04597294: Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: HIPEC
FLOT
Gastric cancer
Lymphadenectomy
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization 1:1
Primary purpose: PREVENTION

Brief summary: The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.

Detailed description: This is a randomized, multicenter, clinical trial in which 598 patients with advanced gastric cancer at high risk of peritoneal metastases are randomly allocated to receive either preoperative hyperthermic intraperitoneal chemotherapy (HIPEC) plus gastrectomy (experimental group) or gastrectomy alone (control group). All patients, regardless of allocation, will additionally receive 4 cycles of FLOT chemotherapy (docetaxel 50 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 and 5-fluorouracil 2600 mg/m2) before surgery ± HIPEC and 4 cycles of FLOT chemotherapy after gastrectomy. The main outcome is frequency of peritoneal recurrence by 6-months post-operative. Patients will be followed for 5 years and undergo additional evaluations at 6 months, 1 year, 3 and 5 years.

The study will take place at 7 hospitals across Poland. All participating centers have the equipment and skills to perform all necessary procedures in this study. The below centers specialize in the treatment of stomach cancer with many documented years of experience. They are trained in the maintenance of a register, possess the skills to conduct appropriate research analyses and are equipped with a system for assessing the quality of both surgical and oncological treatment.

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.

Primary outcomes:
measure: Peritoneal recurrence rate
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: 6 months
measure: Overall survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 5 years
measure: Local recurrence rate
timeFrame: 3 years
measure: Systemic recurrence rate
timeFrame: 3 years
measure: Local recurrence rate
timeFrame: 5 years
measure: Systemic recurrence rate
timeFrame: 5 years
measure: Complications rate
timeFrame: 6 months
measure: Treatment-related quality of life assessed by Quality Of Life Questionnaire (QLQ) C30 version 3.0
timeFrame: 6 months
measure: Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (STO22)
timeFrame: 6 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of General, Oncological, Gastroenterological Surgery and Transplantology
state: Lesser Poland Voivodship
Study officials:
affiliation: Jagiellonian University
name: Piotr Richter, Professor
role: STUDY_DIRECTOR
References: