Non Small Cell Lung CancerPhase 3NCT00441922
Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)
A Phase 3 study testing Docetaxel and Vinorelbine in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
Trial summary
This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced NSCLC. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Docetaxel and Vinorelbine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 10 sitesGreece
- Study dates
- Jan 2003to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Greece10 sites
University General Hospital of Alexandroupolis, Department of Medical Oncology
Alexandroupoli
401 Military Hospital of Athens
Athens
Air Forces Military Hospital of Athens
Athens
IASO General Hospital of Athens, 1st Department of Medical Oncology
Athens
Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine
Athens
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
Athens
Sotiria General Hospital, 1st, 3rd, 8th Department of Pulmonary Diseases
Athens
State General Hospital of Larissa, Department of Medical Oncology
Larissa
Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
Piraeus
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki
About this study
Official title: 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)
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
- Non Small Cell Lung Cancer
- Being tested
- Docetaxel, Vinorelbine
- Keywords
- Cancer, Elderly, Chemotherapy, Docetaxel, Vinorelbine
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
VinorelbineDrug
Also called Navelbine
Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | D Receives: Drug: Docetaxel |
| 2 | Experimental | V Receives: Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival between the two treatment arms
Measured: 1 year
Secondary outcomes (2)
Time to disease progression
Measured: 1 year
Toxicity profile
Measured: During the time of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startJan 2003
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Investigators
- Lampros Vamvakas, MD, Principal investigator, University Hospital of Crete, Department of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441922
- Sponsor's protocol ID
- CT/03.07
- Status last verified
- Oct 2008
- First submitted
- 28 Feb 2007
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00441922
- Acronym / sponsor ID
- CT/03.07
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Cancer, Elderly, Chemotherapy, Docetaxel, Vinorelbine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Jan 2003
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced NSCLC.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DocetaxelD |
| 2 | Experimental | Drug: VinorelbineV |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: TaxotereDocetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles | Drug | 1 |
| VinorelbineAlso: NavelbineVinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles | Drug | 2 |
Primary outcome
Overall survival between the two treatment arms
Time frame: 1 year
2 secondary outcomes
Time to disease progression
Time frame: 1 year
Toxicity profile
Time frame: During the time of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lampros Vamvakas, MD principal investigator
University Hospital of Crete, Department of Medical Oncology
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel and Vinorelbine in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival between the two treatment arms (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2008; AzTrials last refreshed its copy on 8 Nov 2026.