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The external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.
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Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy or in combination with Enoxaparin in patients aged older than 18 years with locally advanced or metastatic non-small cell lung cancer (stadium IIIb/IV), a phase III study. Study hypothesis: Increase of progressive free survival from 5 to 7.5 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm B: Enoxaparin | Experimental |
| |
| Arm A: No Enoxaparin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug |
| ||
| No Enoxaparin |
| Measure | Description | Time Frame |
|---|---|---|
| Progressive free survival | monthly |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | monthly | |
| RECIST | monthly | |
| Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Dickgreber, MD | Hannover Medical School | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School, Department of Pneumology | Hanover | Lower Saxonia | 30625 | Germany |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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|
| every three months |
| thromboembolic complications | monthly |
| safety of long term application of Enoxaparin | monthly |
| overall toxicity | monthly |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002241 |
| Carbohydrates |