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| Name | Class |
|---|---|
| Pierre Fabre Pharma GmbH | INDUSTRY |
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This is a multicenter, open-label, randomised, phase III study of 2 cycles of oral vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either two more cycles of consolidation therapy with oral vinorelbine and cisplatin plus Best Supportive Care (BSC) or BSC alone in patients with unresectable locally advanced non small cell lung cancer (NSCLC).
The primary objective is to compare progression-free survival in both arms, the secondary is to evaluate the response rate, overall survival in both arms, to evaluate the safety profile in both arms and to assess quality of life by the LCSS questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other |
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| B | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose) | Drug | q 28 days :
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| Measure | Description | Time Frame |
|---|---|---|
| Assessments of measurable and not measurable lesions been carried out at baseline and every 2 treatment cycles by using RECIST criteria | at baseline and every 2 treatment cycles and Regular Follow Up at 2 months intervals during the 1st year after completion of treatment and then every 3 months until progression of the last evaluable patient |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of measurable and not measurable lesions been carried out at baseline and every 2 treatment cycles by using RECIST criteria, LCSS QOL Questionnaire and Physical Examination | At baseline and every 2 treatment cycles, Regular follow up at 2 months intervals during 1 year and then every 3 months |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcello RIGGI, Clinical Development Director | Institut de Recherche Pierre Fabre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pierre Fabre Pharma GmbH | Freiburg im Breisgau | Jechtinger Str. 13 | D-79111 | Germany |
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| Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose) | Drug | q 21 days :
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| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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