Ignite Creation Date:
2024-05-06 @ 2:05 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01967875
Status:
TERMINATED
Last Update Posted:
2019-05-30
First Post:
2013-10-15
Brief Title:
A Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer
Sponsor:
China Medical University China
Organization:
China Medical University China
Study Overview
Official Title:
A Prospective Multi-Center Randomized Control Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether ERCC1excision repair cross-complementation 1 expression has effects on platinum-based chemotherapy for patients with locally advanced or metastatic gastric cancer and to explore if ERCC1 can act as a biological predictor for the individual therapy of gastric cancer
Detailed Description:
This is a prospective multi-center randomized control clinical trial aimed to demonstrate if ERCC1 expression could predict the efficacy of platinum-based chemotherapy in patients with locally advanced or metastatic gastric cancer A total of 180 patients are planned to be enrolled into the study ERCC1 protein expression in paraffin-embedding tumor tissue is examined by immunohistochemistry IHC Patients with low ERCC1 expression group L will be treated with XP regimen Patients with high ERCC1 expression will be randomized into group H-A or group H-B and be treated with XP or DX regimen respectively The primary end point is progression free survival PFS and the secondary end points include the median overall survival objective response rate ORRdisease control rateDCR duration of response safetynumber and degree of adverse events and the quality of life QOL
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