Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525714
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Effect of HIPEC After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Prophylactic Hyperthermic Intraperitonal ChemotherapyHIPECAfter Radical Surgery on Long-term Survival for Locally Advanced Gastric CancercT3NM0 and cT4aN-M0 A Randomized-controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study focuses on patients with locally advanced gastric adenocarcinoma cT3NM0 and cT4aN-M0 assessing the feasibility surgical safety and oncological benefit of prophylactic HIPEC treatment following laparoscopic D2 radical surgery
Detailed Description:
Patients meeting the inclusion criteria will undergo laparoscopic D2 radical surgery Before closing the abdomen during surgery heat perfusion tubes are inserted typically placing four tubes in a cross arrangement Two drainage tubes at the pelvic floor exit through the upper abdomen and two drainage tubes at the hepatorenal and splenorenal recesses exit through the lower abdomen thus completing the tube placement
Within 48 hours postoperative the first infusion was performed with 3000-4000 ml of saline and 50 mgm2 cisplatin at 43C with an infusion rate of 600 mlmin for a duration of 2 hours During treatment close attention is given to the patients heart rate blood pressure oxygenation and other vital signs A total of 2 HIPEC treatments were conducted each 48 hours apart Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX intravenous injection of oxaliplatin 130 mgm2 on the first day and oral administration of tegafur 40-60 mg twice daily with doses adjusted for body surface area 125 m2 40 mg 125m2 body surface area 15m2 50mg body surface area 15m2 60 mg bid from day 1 to 14
HIPEC is not performed postoperative Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX intravenous injection of oxaliplatin 130 mgm2 on the first day and oral administration of tegafur 40-60 mg twice daily with doses adjusted for body surface area 125 m2 40 mg 125m2 body surface area 15m2 50mg body surface area 15m2 60 mg bid from day 1 to 14
Within 48 hours postoperative the first infusion was performed with 3000-4000 ml of saline and 50 mgm2 cisplatin at 43C with an infusion rate of 600 mlmin for a duration of 2 hours During treatment close attention is given to the patients heart rate blood pressure oxygenation and other vital signs A total of 2 HIPEC treatments were conducted each 48 hours apart Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX intravenous injection of oxaliplatin 130 mgm2 on the first day and oral administration of tegafur 40-60 mg twice daily with doses adjusted for body surface area 125 m2 40 mg 125m2 body surface area 15m2 50mg body surface area 15m2 60 mg bid from day 1 to 14
HIPEC is not performed postoperative Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX intravenous injection of oxaliplatin 130 mgm2 on the first day and oral administration of tegafur 40-60 mg twice daily with doses adjusted for body surface area 125 m2 40 mg 125m2 body surface area 15m2 50mg body surface area 15m2 60 mg bid from day 1 to 14
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None