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Recruiting NCT04597294

Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence

Phase III Interventional Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FLOT + HIPEC + Surgery, FLOT + Surgery.
Who it may be relevant to
Registry conditions: Gastric Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Combination product FLOT + HIPEC + Surgery
    HIPEC with irinotecan after 4 doses of preoperative FLOT chemotherapy
  • Combination product FLOT + Surgery
    Perioperative FLOT chemotherapy (4 doses before and 4 doses after gastrectomy) and surgery

Primary outcome measures

  • Peritoneal recurrence rate [Time frame: 6 months]
Secondary outcome measures (10)
  • Overall survival [Time frame: 6 months]
  • Overall survival [Time frame: 3 years]
  • Overall survival [Time frame: 5 years]
  • Local recurrence rate [Time frame: 3 years]
  • Systemic recurrence rate [Time frame: 3 years]
  • Local recurrence rate [Time frame: 5 years]
  • Systemic recurrence rate [Time frame: 5 years]
  • Complications rate [Time frame: 6 months]
  • Treatment-related quality of life assessed by Quality Of Life Questionnaire (QLQ) C30 version 3.0 [Time frame: 6 months]
  • Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (STO22) [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Poland · 1 center
  • Department of General, Oncological, Gastroenterological Surgery and Transplantology — Krakow

Identifiers

NCT: NCT04597294 · Gastric CHIMERA Trial · 2020-001419-25 · 2019/ABM/01/00020-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗