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This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.
Primary endpoint: Overall Response Rate
Secondary endpoint: Time to progression, overall survival, safety data
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel 50mg/m2 iv drip, repeat every two weeks; Efficacy will be evaluated every three cycles. | ||
| Fluorouracil | Drug | Fluorouracil 400mg/m2 iv D1; Fluorouracil 2400mg/m2 civ 46 hours; repeat fortnightly and evaluate every two cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate according to RECIST 1.1 | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | One year | |
| Overall survival | One year | |
| Incidence of grade 3 or 4 toxicity |
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Inclusion Criteria:
Hemoglobin 90g/L WBC 3.5 x 109/L Neutrophils 1.5 x 109/L Platelets 100 x 109/L Creatinine 133 umol/L and creatinine clearance 60 mL/min
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510655 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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The criteria to grade the toxicity is NCI CTC 3.0
| One year |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |