Gastric Cancer
Conditions
Keywords
HIPEC, FLOT, Gastric cancer, Lymphadenectomy
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.
Interventions
COMBINATION_PRODUCTFLOT + HIPEC + Surgery
HIPEC with irinotecan after 4 doses of preoperative FLOT chemotherapy
COMBINATION_PRODUCTFLOT + Surgery
Perioperative FLOT chemotherapy (4 doses before and 4 doses after gastrectomy) and surgery
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomization 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peritoneal recurrence rate | 6 months | The rate of peritoneal recurrences at 6 month time from randomisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence rate | 3 years | Locoregional recurrence rate at 3 year follow-up |
| Systemic recurrence rate | 3 years | Systemic recurrence rate at 3 year follow-up |
| Overall survival | 6 months | Overall survival at 6 month follow-up |
| Treatment-related quality of life assessed by Quality Of Life Questionnaire (QLQ) C30 version 3.0 | 6 months | Score range 0-100, higher score represents a higher (better) level of functioning |
| Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (STO22) | 6 months | Score range 0-100, higher scores represent worse quality of life |
| Complications rate | 6 months | According to CTCAE version 5 and Clavien-Dindo classification |
Countries
Poland
Contacts
Primary ContactPiotr Richter, Professor
Outcome results
None listed