The purpose of this study is to determine whether ERCC1(excision repair cross-complementation 1 ) expression has effects on platinum-based chemotherapy for patients with locally advanced or metastatic gastric cancer, and to explore if ERCC1 can act as a biological predictor for the individual therapy of gastric cancer
This is a prospective, multi-center, randomized control clinical trial, aimed to demonstrate if ERCC1 expression could predict the efficacy of platinum-based chemotherapy in patients with locally advanced or metastatic gastric cancer. A total of 180 patients are planned to be enrolled into the study. ERCC1 protein expression in paraffin-embedding tumor tissue is examined by immunohistochemistry (IHC). Patients with low ERCC1 expression (group L) will be treated with XP regimen. Patients with high ERCC1 expression will be randomized into group H-A or group H-B, and be treated with XP or DX regimen, respectively. The primary end point is progression free survival (PFS), and the secondary end points include the median overall survival, objective response rate (ORR),disease control rate(DCR), duration of response, safety(number and degree of adverse events), and the quality of life (QOL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Cisplatin 75mg/m2, d1; Capecitabine 1700-2000mg/m2/day on days1-14 every 21 days, 6 cycles.Capecitabine is to be continued until disease progression or intolerable toxicity.
Docetaxel 75mg/m2, d1; Capecitabine 1700-2000mg/m2/day on days1-14 every 21 days, 6 cycles. Capecitabine is to be continued until disease progression or intolerable toxicity.
The Fourth Hospital of Anshan
Anshan, Liaoning, China
The First Hospital of Dalian Medical University
Dalian, Liaoning, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Hospital of Liaoning Medical University
Jinzhou, Liaoning, China
Progression-Free Survival (PFS)
Time frame: 2 years
Overall Survival(OS)
Time frame: 2 years
Objective Response Rate(ORR),Including Complete Response(CR) and Partial Response(PR)
Time frame: 2 years
Disease Control Rate(DCR), Including Complete Response(CR) , Partial Response(PR) and Stable Disease(SD)
Time frame: 2 years
Duration of Response
Time frame: 2 years
Safety(number and degree of adverse events)
Time frame: 2 years
Quality of Life(QOL)
Time frame: 2 years
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The First Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Tumor Hospital
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China