Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01424709
Status:
UNKNOWN
Last Update Posted:
2014-09-25
First Post:
2011-05-09
Brief Title:
Individualized Chemotherapy Based on BRCA1 and RRM1 mRNA for Advanced Non-small Cell Lung Cancer NSCLC
Sponsor:
Tongji University
Organization:
Tongji University
Study Overview
Official Title:
Individualized 1st Line Chemotherapy Based on BRCA1 and RRM1 mRNA Expression Levels for Advanced Non-small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
BRAVO
Brief Summary:
Gemcitabine docetaxel CPT-11 and cisplatin are effective in 1st line treatment of advanced non-small cell lung cancer NSCLC Platinum-based doublets including gemcitabine docetaxel or CPT-11 are standard 1st regimens BRCA1 and RRM1 expression levels are reported to be associated with sensitivity of the tumor cells to cytotoxic agents Some Phase II or III trials did prove feasibility of customized chemotherapy based upon expression levels of one or two biomarkers in the NSCLC patients The investigators think customized chemotherapy may further improve efficacy of chemotherapy in advanced NSCLC But there is no randomised trial to compare efficacy of standard chemotherapy with individualized chemotherapy in this setting So the investigators plan to initiate this phase II trial to compare efficacy between standard chemotherapy of gemcitabinecisplatin versus customized chemotherapy in chemonaive NSCLC patients
Detailed Description:
Primary end pointORR Secondary end pointPFSOSsafetyQOLetc
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