A Phase 2 interventional study of Docetaxol and Oxaliplatin in Gastric Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-10-16.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
Platinum, fluorouracil and taxane based regimen are all acceptable in the first line treatment of metastatic gastric cancer. The TX and XELOX regimen are two common regimen used in MGC. whichever regimen is used, the average response rate is less than 50%. So a rather part of patients can't get benefit from the treatment. It is urgent to find out the predictive factors of these regimens in order to get a higher response and better survival outcome.
Patients with MGC will be treated with TX or XELOX regimen. Before treatment, 14 days after treatment and after progression, the blood sample will be collected. Primary tumor blocks will also of collected. These samples will be used to detect predictive factors of the two types first line therapy.
2,851 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.
This study's planned enrollment of 120 is above the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Docetaxol: 75 mg/m2 d1, (From MAY 15th 2013, the dose was reduced to 60mg/m2 for high incidence of G3/4 myelosuppression after approved by institute Ethics Committee) ; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
Drug: Docetaxol · Drug: Capecitabine
Oxaliplatin: 130 mg/m2 d1; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
Drug: Oxaliplatin · Drug: Capecitabine
Also known as: xeloda
objective response
RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) will be used to evaluate the response of each patient every 6 weeks. The main purpose of this study is to search for the biomarkers which will predict the response of patients with MGC received TX or XELOX regimen as first line therapy
Time frame: 6 weeks
progression free survival (PFS)
PFS is defined as from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Time frame: From randomization until first documented progression or date of death from any cause, whichever came first (up to 60 months)
overall survival(OS)
OS is defined as from the date of randomization until the date of death from any cause, assessed up to 60 months
Time frame: from the date of randomization until the date of death from any cause, assessed up to 60 months
This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Fudan University