Clinical trial · Interventional
Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)
A Multicenter Randomized Phase II Study of Docetaxel Versus Vinorelbine as First-Line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)
NCT00441922CI-TRIAL-00001758completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced NSCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- D
- interventionNames
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- 2
- description
- V
- interventionNames
- Drug: Vinorelbine
Primary outcomes (1)
- measure
- Overall survival between the two treatment arms
- timeFrame
- 1 year
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer * Stage IIIB/IV * No prior chemotherapy * Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated * Life expectancy of more than 3 months * Age ≥ 65 years * Performance status (WHO) ≤ 3 * Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, Hemoglobin \> 9 gr/mm\^3) * Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal), and renal function (creatinine \< 2 mg/dl) * Informed consent Exclusion Criteria: * Psychiatric illness or social situation that would preclude study compliance. * Other concurrent uncontrolled illness * Other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No absence or irradiated and stable central nervous system metastatic disease. * No presence of a reliable care giver * Other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.