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| ID | Type | Description | Link |
|---|---|---|---|
| Dutch trialregister | Registry Identifier | NTR2306 | |
| 2007-007273-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Eindhoven Cancer Registry | OTHER |
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The purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore, an extended type of removal of lymph nodes will be implemented.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 60 mg/m2, 1 gift every 3 weeks, in total 4 gifts |
| |
| cisplatin | Drug | 60 mg/m2, one gift every three weeks, in total 4 gift | ||
| Capecitabine | Drug | 1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles |
| |
| D1extra-resection | Procedure | An extended lymphadenectomy compared to a D1 resection for gastric cancer |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients with (serious) adverse events receiving the combination of 4 courses of docetaxel, cisplatin and capecitabine as neoadjuvant chemotherapy and standardized surgery in resectable localized or locally advanced gastric cancer. | Patients receive every 3 weeks a cycle of chemotherapy, in total 4 cylcles will be given. Surgery will be performed approximately 6 weeks after the last cycle. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VieCuri Hospital | Venlo | Limburg | 5912 BL | Netherlands | ||
| Jeroen Bosch Hospital |
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| 's-Hertogenbosch |
| North Brabant |
| 5200 ME |
| Netherlands |
| Catharina Hospital | Eindhoven | North Brabant | 5602 ZA | Netherlands |
| Elkerliek Hospital | Helmond | North Brabant | 5700 AB | Netherlands |
| Maxima Medical Centre | Veldhoven | North Brabant | 5500 MB | Netherlands |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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