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

Gastric Cancer Clinical Trial

— CHIMERA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04597294
• Other study ID #: Gastric CHIMERA Trial
• Secondary ID: 2020-001419-2520
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2021
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Jagiellonian University
• Contact: Piotr Richter, Professor
• Phone: +48124002400
• Email: piotr.richter[@]uj.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Recurrence
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Poland	Department of General, Oncological, Gastroenterological Surgery and Transplantology	Krakow	Lesser Poland Voivodship

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peritoneal recurrence rate	The rate of peritoneal recurrences at 6 month time from randomisation	6 months
Secondary	Overall survival	Overall survival at 6 month follow-up	6 months
Secondary	Overall survival	Overall survival at 3 year follow-up	3 years
Secondary	Overall survival	Overall survival at 5 year follow-up	5 years
Secondary	Local recurrence rate	Locoregional recurrence rate at 3 year follow-up	3 years
Secondary	Systemic recurrence rate	Systemic recurrence rate at 3 year follow-up	3 years
Secondary	Local recurrence rate	Locoregional recurrence rate at 5 year follow-up	5 years
Secondary	Systemic recurrence rate	Systemic recurrence rate at 5 year follow-up	5 years
Secondary	Complications rate	According to CTCAE version 5 and Clavien-Dindo classification	6 months
Secondary	Treatment-related quality of life assessed by Quality Of Life Questionnaire (QLQ) C30 version 3.0	Score range 0-100, higher score represents a higher (better) level of functioning	6 months
Secondary	Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (STO22)	Score range 0-100, higher scores represent worse quality of life	6 months