Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597294
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2020-10-15
Brief Title:
Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
Sponsor:
Jagiellonian University
Organization:
Jagiellonian University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHIMERA
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 mgm2 oxaliplatin 85 mgm2 leucovorin 200 mgm2 and 5-fluorouracil 2600 mgm2 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019ABM0100020-00 | OTHER_GRANT | Medical Research Agency | None |
| 2020-001419-25 | EUDRACT_NUMBER | None | None |