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| Name | Class |
|---|---|
| Pierre Fabre Laboratories | INDUSTRY |
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The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC) treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant radiotherapy in elderly patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin IV | Drug | Cisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | during treatment and during the 4 weeks following the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Late toxicity | 6 months after the end of the treatment | |
| Overall response rate | 4 weeks after treatment |
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Inclusion Criteria:
The disease
Exclusion Criteria:
The disease
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| Name | Affiliation | Role |
|---|---|---|
| Chrystèle LOCHER, MD | CH Meaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Brest | France | ||||
| Centre Hospitalier GAP |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 15, 2018 | |
| Reset | Feb 12, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 15, 2018 | Feb 12, 2019 |
| 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 |
|---|---|
| D000077235 | Vinorelbine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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| Vinorelbine |
| Drug |
Vinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36 |
|
| Radiotherapy | Radiation | 66Gy, 33 fractions, 6 week |
|
| Gap |
| France |
| Département de Pathologie Respiratoire du CHU de Limoges | Limoges | France |
| CH de Meaux | Meaux | France |
| CHU Reims | Reims | France |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013812 | Therapeutics |