Clinical trial · Interventional
Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC
A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)
NCT00442026CI-TRIAL-00007273terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to poor accrual
Summary
Brief summary (as posted)
This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine 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 |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- DG
- interventionNames
- Drug: Docetaxel
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- 2
- description
- G
- interventionNames
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Overall survival between the two treatment arms
- timeFrame
- Probability of 1 year survival (%)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer * Stage IIIB/IV * No prior chemotherapy * Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated. * Absence or irradiated and stable central nervous system metastatic disease * Life expectancy of more than 3 months * Age ≥ 70 years. * Performance status (WHO) \< 3 * Patients "non-frail" according to comprehensive geriatric assessment * Adequate bone marrow function (Absolute neutrophil count \> 1000/mm\^3, Platelet count \> 100000/mm\^3, Hemoglobin \> 9gr/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 \< 2mg/dl). * Adequate cardiac function (LVEF \> 50%). * 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 presence of a reliable care giver * Other concurrent investigational agents.
References
Publications (1)
- DERIVEDKarampeazis A, Vamvakas L, Kotsakis A, Christophyllakis C, Kentepozidis N, Chandrinos V, Agelidou A, Polyzos A, Tsiafaki X, Hatzidaki D, Georgoulias V. Docetaxel plus gemcitabine versus gemcitabine in elderly patients with advanced non-small cell lung cancer and use of a geriatric assessment: Lessons from a prematurely closed Hellenic Oncology Research Group randomized phase III study. J Geriatr Oncol. 2017 Jan;8(1):23-30. doi: 10.1016/j.jgo.2016.05.002. Epub 2016 Jun 2. PMID 27264267