Lung CancerPhase 3NCT00148291
Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer
A Phase 3 study testing Patients were randomized to receive either docetaxel 60 mg/m2 on day 1 or vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles. in people with Lung Cancer, run by West Japan Thoracic Oncology Group.
Trial summary
Vinorelbine is currently the standard treatment for elderly patients with advanced non-small cell lung cancer (NSCLC). Docetaxel has also shown promising results against elderly patients in phase II studies. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Patients were randomized to receive either docetaxel 60 mg/m2 on day 1 or vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles.
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jun 1999to not given
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Chemotherapy- and radiotherapy-naïve patients with histologically or cytologically diagnosis of stage IIIB or IV NSCLC and who were ≧ 70 years old with measurable or assessable disease were eligible for this trial. They had to have a life expectancy of at least 3 months. Additional entry criteria were as follows: (a) a performance status (PS) 0 to 2 on the Eastern Cooperative Oncology Group scale; (b) adequate function of bone marrow (leukocyte count ≧ 4,000/μL, absolute neutrophil count ≧ 2,000/μL, hemoglobin concentration ≧ 9.5 g/dL, platelet count ≧ 100,000/μL), kidney (serum creatinine ≦ 1.2 mg/dL), liver (total bilirubin ≦ 1.5 times the institutional upper limits of normal, transaminase of AST and ALT ≦ 2.5 times the institutional upper limits of normal).
Who cannot join
- Patients with symptomatic brain metastasis or apparent dementia were ineligible. Patients with active concomitant malignancy, massive pleural effusion or ascites, active infection, severe heart disease, grade 2 or higher ECG abnormality, uncontrolled diabetes mellitus, ileus, pulmonary fibrosis, diarrhea, and a bleeding tendency were excluded.-
About this study
Vinorelbine is currently the standard treatment for elderly patients with advanced non-small cell lung cancer (NSCLC). Docetaxel has also shown promising results against elderly patients in phase II studies. We conducted a randomized phase III trial to evaluate whether docetaxel provided better overall survival than vinorelbine in elderly patients with advanced NSCLC.
- Conditions
- Lung Cancer
- Being tested
- Patients were randomized to receive either docetaxel 60 mg/m2 on day 1 or vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles.
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients were randomized to receive either docetaxel 60 mg/m2 on day 1 or vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles.Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 180 participants
Sponsor and investigators
- Lead sponsor
- West Japan Thoracic Oncology Group
- Sponsor type
- University, hospital or other
- Investigators
- Shinzoh Kudoh, MD, Principal investigator, West Japan Thoracic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148291
- Sponsor's protocol ID
- WJTOG9904
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2005
- Last updated
- 6 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00148291
- Acronym / sponsor ID
- WJTOG9904
- Conditions
- Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- West Japan Thoracic Oncology GroupUniversity, hospital or other
- Study start
- Jun 1999
- First posted
- 7 Sep 2005 (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.
Vinorelbine is currently the standard treatment for elderly patients with advanced non-small cell lung cancer (NSCLC). Docetaxel has also shown promising results against elderly patients in phase II studies. We conducted a randomized phase III trial to evaluate whether docetaxel provided better overall survival than vinorelbine in elderly patients with advanced NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Chemotherapy- and radiotherapy-naïve patients with histologically or cytologically diagnosis of stage IIIB or IV NSCLC and who were ≧ 70 years old with measurable or assessable disease were eligible for this trial. They had to have a life expectancy of at least 3 months. Additional entry criteria were as follows: (a) a performance status (PS) 0 to 2 on the Eastern Cooperative Oncology Group scale; (b) adequate function of bone marrow (leukocyte count ≧ 4,000/μL, absolute neutrophil count ≧ 2,000/μL, hemoglobin concentration ≧ 9.5 g/dL, platelet count ≧ 100,000/μL), kidney (serum creatinine ≦ 1.2 mg/dL), liver (total bilirubin ≦ 1.5 times the institutional upper limits of normal, transaminase of AST and ALT ≦ 2.5 times the institutional upper limits of normal).
Key exclusion criteria (1 listed)
- Patients with symptomatic brain metastasis or apparent dementia were ineligible. Patients with active concomitant malignancy, massive pleural effusion or ascites, active infection, severe heart disease, grade 2 or higher ECG abnormality, uncontrolled diabetes mellitus, ileus, pulmonary fibrosis, diarrhea, and a bleeding tendency were excluded.-
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 |
|---|---|---|
| Patients were randomized to receive either docetaxel 60 mg/m2 on day 1 or vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles. | Drug | – |
Primary outcome
Not reported in the source record.
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 6 Jan 2006.
- Related InfoLink provided by the sponsor.
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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.
Shinzoh Kudoh, MD principal investigator
West Japan Thoracic Oncology Group
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Patients were randomized to receive either docetaxel 60 mg/m2 on day 1 or vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles. in people with Lung Cancer, run by West Japan Thoracic Oncology Group.
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 1 inclusion and 1 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 6 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
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.
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 6 Jan 2006.