Ignite Creation Date:
2024-05-06 @ 3:07 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02204306
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2014-07-21
Brief Title:
Genotype Guided Chemotherapy in Gastric Cancer Patients
Sponsor:
Central South University
Organization:
Central South University
Study Overview
Official Title:
TSER Genotype Guided Chemotherapy in Metastatic Gastric Cancer Patients A Phase II Study in China
Status:
COMPLETED
Status Verified Date:
2019-11
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:
In gastric cancer patients treated with 5-FU and cisplatin higher tumor TS levels were associated with a less favorable response 29 vs 68 p0024 Similarly in a study in which patients were treated with high dose 5-FU patients with high TS expression had a response rate of only 125 Conversely a response rate of 929 was observed in patients with low tumor TS expression A longer but not statistically significant survival advantage was observed in patients with the TSER2 allele compared with the TSER33 patients Additionally a review by Patel et al identified approximately 20 gastric cancer studies that have found a positive association between TSER genotype and clinical response in either direction Therefore the primary goal of this proposal is to prospectively genotype patients select patients with good risk TSER genotypes TSER22 or 23 and treat them with a standard 5-FU containing regimen FOLFOX in order to improve clinical outcomes while randomize patients with the poor risk TSER genotype 33 to either the standard 5-FU containing regimen or another non-5-FU-based regimen docetaxelcisplatin
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1000 Plan | OTHER | 1000 Plan Program | None |