Ignite Creation Date:
2024-05-05 @ 11:36 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01364493
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2011-05-31
Brief Title:
A Study to Evaluate the Efficacy and Safety of Trastuzumab in Combination With Capecitabine and Oxaliplatin as First-line Chemotherapy for Inoperable Locally Advanced or Recurrent andor Metastatic Gastric Cancer
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
An Open-label Single Arm Study to Evaluate the Efficacy and Safety of Trastuzumab in Combination With Capecitabine and Oxaliplatin XELOX as a First-line Chemotherapy for Inoperable Locally Advanced or Recurrent andor Metastatic Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Although the overall incidence of gastric cancer has steadily declined in many Western countries during the last few decades it is still one of the most common tumors in China It is now well recognised that combination chemotherapy regimens improve patient outcomes but there is no accepted global standard regimen for advanced gastric cancer
The ToGA study was the first randomized prospective multicenter phase III trial to show the efficacy and safety of Trastuzumab in HER2- positive GC Trastuzumab reduced the risk of death by 26 HR 074 95 CI 060 091 p00046 when combined with a reference chemotherapy Capecitabine plus Cisplatin and prolonged the median survival by nearly 3 months from 111 to 138 months in patients with HER2-positiveFISH or IHC3 advanced GC
Oxaliplatin has been shown to be as effective as cisplatin and exhibits a favorable toxicity profile with a substantially lower rate of nephrotoxicity ototoxicity and myelosuppression
In the current study the efficacy and safety of Trastuzumab in combination with Oxaliplatincapecitabine chemotherapy will be evaluated in Chinese patients with HER2 positive advanced or recurrent gastric cancer
The ToGA study was the first randomized prospective multicenter phase III trial to show the efficacy and safety of Trastuzumab in HER2- positive GC Trastuzumab reduced the risk of death by 26 HR 074 95 CI 060 091 p00046 when combined with a reference chemotherapy Capecitabine plus Cisplatin and prolonged the median survival by nearly 3 months from 111 to 138 months in patients with HER2-positiveFISH or IHC3 advanced GC
Oxaliplatin has been shown to be as effective as cisplatin and exhibits a favorable toxicity profile with a substantially lower rate of nephrotoxicity ototoxicity and myelosuppression
In the current study the efficacy and safety of Trastuzumab in combination with Oxaliplatincapecitabine chemotherapy will be evaluated in Chinese patients with HER2 positive advanced or recurrent gastric cancer
Detailed Description:
Trastuzumab will be administered at a loading dose of 8 mgkg on day 1 followed by 6mgkg iv infusion every 3 weeks
Trastuzumab is to be continued until disease progression or intolerable toxicity
Capecitabine Xeloda 2000mgm2d d1-14 q3w until disease progression or intolerable toxicity
Oxaliplatin 130mgm2 d1 q3w 6 cycles
Trastuzumab is to be continued until disease progression or intolerable toxicity
Capecitabine Xeloda 2000mgm2d d1-14 q3w until disease progression or intolerable toxicity
Oxaliplatin 130mgm2 d1 q3w 6 cycles
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