Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510010
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Perioperative Oxaliplatin With S-1 Combined H Pylori Eradication in the Management of Locally Advanced Gastric Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Perioperative Oxaliplatin With S-1 Combined H Pylori Eradication in the Management of Locally Advanced Adenocarcinoma of the Gastric and Oesophagogastric Junction an Open-label Prospective Multicenter Randomised Phase 2 Trial
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:
This study focuses on patients with H pylori-positive resectable locally advanced adenocarcinoma of the gastric and oesophagogastric junction It evaluates the perioperative oxaliplatin with S-1 SOX combined H pylori eradication versus oxaliplatin with S-1 in the management of H pylori-positive locally advanced adenocarcinoma of the gastric and oesophagogastric junction cT34a Nx or T2 N23 M0 assessing their values and advantages
Detailed Description:
Subjects randomized to the trial group will receive 3-4 cycles of oxaliplatin with S-1 SOX H pylori eradication a 14-day quadruple regimen amoxicillin clarithromycin omeprazole bismuth potassium citrate before surgery One of the SOX regimens will be every 3 weeks Q3W with a tumor response assessment at the end of the neoadjuvant therapy course Patients will continue to receive 4-5 cycles of SOX adjuvant chemotherapy after surgery for a total of 8 cycles of SOX regimen treatment Patients in the trial group will undergo H pylori eradication at the time of the first cycle of the SOX regimen H pylori eradication will be determined by postoperative pathology and those who are H pylori-positive by postoperative pathology will be treated with remedial eradication therapy after recovery from surgery except for patients with total gastric resection
Subjects randomized to the control group will receive 3-4 cycles of neoadjuvant therapy with the SOX regimen before surgery The SOX regimen will be administered every 3 weeks Q3W A tumor response assessment will be performed at the end of the treatment course Control patients were treated with H pylori eradication after recovery from surgery based on postoperative pathologic H pylori results if H pylori-positive they received H pylori eradication plus 4-5 cycles of SOX adjuvant chemotherapy except for patients who underwent total gastric resection if H pylori-negative they received 4-5 cycles of SOX adjuvant chemotherapy only
Subjects randomized to the control group will receive 3-4 cycles of neoadjuvant therapy with the SOX regimen before surgery The SOX regimen will be administered every 3 weeks Q3W A tumor response assessment will be performed at the end of the treatment course Control patients were treated with H pylori eradication after recovery from surgery based on postoperative pathologic H pylori results if H pylori-positive they received H pylori eradication plus 4-5 cycles of SOX adjuvant chemotherapy except for patients who underwent total gastric resection if H pylori-negative they received 4-5 cycles of SOX adjuvant chemotherapy only
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