Ignite Creation Date:
2024-05-06 @ 2:26 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02048540
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2014-01-25
Brief Title:
Neoadjuvant Bev Plus DOF vs DOF in LAGC and Its Association With Circulating Tumor Cell
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Phase 2 Study of Neoadjuvant Bevacizumab Plus DOF Versus DOF in Local Advanced Gastric Carcinoma and Its Association With Circulating Tumor Cell
Status:
COMPLETED
Status Verified Date:
2014-04
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:
Background Local advanced gastric carcinoma LAGC is suggested to be potentially cured by R0 resection and neoadjuvant chemotherapy can increase the R0 resection rate but not enough Bevacizumab Bev an anti-tumor angiogenesis monoclonal antibody combined with chemotherapy has been shown effective in advanced GC In addition CTC has been suggested as an indicator of the anti-tumor drugs efficacy Therefore in this study the investigators plan to evaluate the efficacy and safety of neoadjuvant Bev plus docetaxeloxaliplatin5-FUCF DOF versus DOF in mainly gastric antrum LAGC and to investigate whether CTC is an effectiveness indicator
Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned 11 to receive neoadjuvant Bev 5 mgkg d1 plus DOF docetaxel 75 mgm2 iv d1 oxaliplatin 85 mgm2 iv d1 5-FU iv infusion 600 mgm2 and iv injection 400mgm2 d1-2 CF 200 mgm2 d1 and d2 or DOF each 3-week up to 2-4 cycles preoperation and another 2-4 cycles postoperation up to total 6 cycles The primary endpoint is R0 resection rate CTC was detected every 8 weeks All patients signed the informed consent
Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned 11 to receive neoadjuvant Bev 5 mgkg d1 plus DOF docetaxel 75 mgm2 iv d1 oxaliplatin 85 mgm2 iv d1 5-FU iv infusion 600 mgm2 and iv injection 400mgm2 d1-2 CF 200 mgm2 d1 and d2 or DOF each 3-week up to 2-4 cycles preoperation and another 2-4 cycles postoperation up to total 6 cycles The primary endpoint is R0 resection rate CTC was detected every 8 weeks All patients signed the informed consent
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 |
|---|---|---|---|
| BSC2013-dunan | OTHER | Beijing science commission | None |