Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06194981
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-22
Brief Title:
Duration of Adjuvant Chemotherapy for Gastric Cancer Patients at Pathological N3 Stage
Sponsor:
The First Affiliated Hospital of Zhengzhou University
Organization:
The First Affiliated Hospital of Zhengzhou University
Study Overview
Official Title:
Duration of Postoperative Adjuvant Chemotherapy 3-4 Months Versus 5-6 Months for Gastric Cancer Patients at Pathological N3 Stage a Retrospective Study
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
The goal of this retrospective study is to compare the efficacy and safety of 3-4 months to 5-6 months of CapOxSOX adjuvant chemotherapy in pathological N3 gastric cancer patients
Detailed Description:
Due to a heavy metastatic node burden pathological stage N3 pN3 gastric cancer GC patients have extremely poor prognoses Except for surgical resection postoperative adjuvant chemotherapy is the major treatment strategy to improve survival for these patients Capecitabine plus oxaliplatin CapOx and S-1 plus oxaliplatin SOX were considered the effective treatment for stage II and III GC after D2 gastrectomy in the CLASSIC and RESOLVE trials But N3b positive lymph nodes 16 and T1-3N3 patients were omitted in these two trials respectively Moreover only 665 of patients finished 6 months of chemotherapy in the CLASSIC trial and in the RESOLVE trial 17-19 of patients required dose reductions and about 19 of patients discontinued chemotherapy due to drug-related toxicity for 6 months of chemotherapy Particularly cumulative administration of oxaliplatin led to peripheral sensory neurotoxicity which caused poor quality of life and treatment compliance Recently a prospective analysis of six randomized phase 3 trials with 12834 participants IDEA trail for stage III colon cancer demonstrated that 3 months of CapOx was as effective as 6 months with relatively lower recurrence risk no significantly different overall survival and fewer adverse effects However there were no relevant studies to explore the optimal duration of chemotherapy for pN3 GC patients
This study aims to compare the efficacy and safety of 3-4 months to 5-6 months of CapOxSOX adjuvant chemotherapy in pathological N3 gastric cancer patients
This study aims to compare the efficacy and safety of 3-4 months to 5-6 months of CapOxSOX adjuvant chemotherapy in pathological N3 gastric cancer patients
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