CompletedNCT00441922Updated Oct 29, 2008

Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)

A Phase 3 interventional study of Docetaxel and Vinorelbine in Non Small Cell Lung Cancer, sponsored by Hellenic Oncology Research Group. Completed at 10 sites in Greece. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-10-29.

Sponsored by Hellenic Oncology Research Group · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 166
Allocation: Randomized
Ages: 65 Years to 80 Years
Sex: All

Study summary

This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced NSCLC.

Read the detailed description

Docetaxel and vinorelbine are well known active agents in the treatment of NSCLC. The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Conditions studied

Non Small Cell Lung Cancer

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Keywords

Cancer
Elderly
Chemotherapy
Docetaxel
Vinorelbine

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 166 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hellenic Oncology Research Group is the lead sponsor of 57 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 166 participants (estimated)

Study arms

Experimental
1
D
Drug: Docetaxel
Experimental
2
V
Drug: Vinorelbine

Interventions

DrugDocetaxel
Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Also known as: Taxotere
DrugVinorelbine
Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Also known as: Navelbine

What researchers measure

Primary outcomes

Overall survival between the two treatment arms
Time frame: 1 year

Secondary outcomes

Time to disease progression
Time frame: 1 year
Toxicity profile
Time frame: During the time of chemotherapy

Study locations

10 sites

University General Hospital of Alexandroupolis, Department of Medical Oncology
Alexandroupolis, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
IASO General Hospital of Athens, 1st Department of Medical Oncology
Athens, Greece
Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine
Athens, Greece
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
Athens, Greece
Sotiria General Hospital, 1st, 3rd, 8th Department of Pulmonary Diseases
Athens, Greece
State General Hospital of Larissa, Department of Medical Oncology
Larissa, Greece
Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
Piraeus, Greece
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki, Greece

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00441922
Lead sponsor: Hellenic Oncology Research Group
Collaborators: University Hospital of Crete
First posted: Mar 1, 2007
Start date: Jan 2003
Primary completion: Jan 2008
Completion: Jan 2008
Last update: Oct 29, 2008

Study contacts

Lampros Vamvakas, MD

principal investigator · University Hospital of Crete, Department of Medical Oncology

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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