Trastuzumab in Combination With Capecitabine and Oxaliplatin(XELOX) in Patients With Advanced Gastric Cancer(AGC) (Her+XELOX)
This is an open-label, multicentre, prospective phase II trial designed to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction.
Metastatic or Recurrent Gastric Adenocarcinoma
Her-2 Positive Gastric Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Trastuzumab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer|
- Overall response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]To evaluate the overall response rate for patients treated with trastuzumab combinated with capecitabine plus oxaliplatin.
- Duration of response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Each 3-weekly cycle, with chemotherapy given for 6 cycles, and trastuzumab continued even after completion of the combination chemotherapy until disease progression
Patients will be administered 6 cycles of combination chemotherapy, unless withdrawn earlier due to unacceptable toxicity, disease progression, or consent withdrawal. Patients will continue to be treated with trastuzumab alone until disease progression, unacceptable toxicity or consent withdrawal after finishing a maximum 6 cycles of combination chemotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396707
|Korea, Republic of|
|Asan Medical Center|
|Songpa-gu, Seoul, Korea, Republic of|
|Principal Investigator:||Yoon-Koo Kang, MD, PhD||Asan Medical Center|