Ignite Creation Date:
2024-05-06 @ 1:21 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01781988
Status:
COMPLETED
Last Update Posted:
2014-12-17
First Post:
2013-01-24
Brief Title:
Personalized Therapy in Non-small Cell Lung Cancer
Sponsor:
Guangzhou Medical University
Organization:
Guangzhou Medical University
Study Overview
Official Title:
The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1RRM1TS Expression
Status:
COMPLETED
Status Verified Date:
2014-12
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:
PTINCLC
Brief Summary:
Excision repair cross complementing 1 ERCC1 ribonucleotide reductase M1 RRM1 and thymidylate synthaseTS are molecular determinants that predict sensitivity or resistance to platinum agents gemcitabine and pemetrexed respectively
Tailored therapy using these molecular determinants suggested patient benefit in a previously reported phase 2 trial Here we designed a study for an individual patient analysis of prospectively accrued patients who were treated with the personalized therapy approach versus other standard approaches
Tailored therapy using these molecular determinants suggested patient benefit in a previously reported phase 2 trial Here we designed a study for an individual patient analysis of prospectively accrued patients who were treated with the personalized therapy approach versus other standard approaches
Detailed Description:
Patients who had nonsmall- cell lung cancer NSCLC performance status of 01 were accrued to 2 phase 2 clinical trials Trial A carboplatin and chemotherapy individuation based on sensitivity marker Trial B carboplatin non-individuation or chemotherapy non-individuation
Patients who were treated on Trials B were analyzed as the standard therapy group Patients accrued to Trial A were called the personalized therapy group disease free survival DFS was estimated using the Kaplan-Meier method
Patients who were treated on Trials B were analyzed as the standard therapy group Patients accrued to Trial A were called the personalized therapy group disease free survival DFS was estimated using the Kaplan-Meier method
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 |
|---|---|---|---|
| PT12521 | OTHER | The First Affiliated Hospital of Guangzhou Medical University | None |