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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra-CT-nr 2006-002927-18 |
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The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2 Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2 All patients will receive a maximum of 3 courses with an interval of 3 weeks |
|
| B | Active Comparator | Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Carboplatin infusion AUC = 5 (Calvert's formula) Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 All patients will receive a maximum of 3 courses with an interval of 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinorelbine | Drug | Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| survival | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life (HrQoL) | 3 months | |
| Toxicity | 3 months | |
| Need for palliative radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Øystein Fløtten | Haukeland University Hospital, thoracic department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Øystein Fløtten | Bergen | 5000 | Norway | |||
| Sverre Fluge |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| D000093542 | Gemcitabine |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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| Gemcitabine | Drug | Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2 |
|
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| Vinorelbine | Drug | Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2 |
|
|
| Carboplatin | Drug | Day 1: Carboplatin infusion AUC = 5 (Calvert's formula) |
|
| one year |
| Haugesund |
| 7000 |
| Norway |
| Heidi Rolke | Kristiansand | Norway |
| Tore Amundsen | Trondheim | 7000 | Norway |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |