Study of Weekly DCF to Treat Advanced Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of weekly docetaxol combined with cisplatin and 5-Fu in patients with AGC.

Detailed Description
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Recently,in a multi-center, open-label randomized phase III study (V325), compared to the control arm of CF regimen, DCF showed higher efficacy in terms of response rate, time to progression and overall survival. But the regimen had increased grade 3-4 neutropenia (82% vs 57%) and febrile neutropenia infection (29% vs 12%). We began to study on weekly DCF in the patients with advanced gastric cancer to evaluate the efficacy no less than that of 3-week' regimen.

Official Title
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Phase II Study of Weekly Docetaxol Combined With Cisplatin and 5-Fu in Patients With Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Docetaxel, Cisplatin, 5-Fu


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 70 years Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma ECOG performance status ≤1,life expectancy more than 3 months, Normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min). Measurable disease according to the RECIST. Exclusion Criteria: Pregnant or lactating women Serious uncontrolled diseases and intercurrent infection The evidence of CNS metastasis History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Received other chemotherapy regimen after metastasis Used taxane in adjuvant settings Participated in other clinical trials.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: weekly chemo<br>Docetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities. | Drug: Docetaxel, Cisplatin, 5-Fu<br>* Docetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities.<br>* Other names: wDCF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate, overall survival |  | 2-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  | 2-6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DCF, Advanced gastric cancer, Phase II study, Efficacy, Toxicity