This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer (NCT00602797), a na phase 2 study. The primary outcome is Progression-free Survival..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00602797 |
| Phase | Phase 2 |
| Condition | Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Nebraska |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns older patients with advanced non-small cell lung cancer, including recurrent disease and stage IV disease. The registry record lists enrollment of 20 participants. It does not provide further details about eligibility criteria or the characteristics of participants who entered the primary endpoint analysis.
Intervention
Participants received vinorelbine tartrate and paclitaxel. The registered schedule describes both drugs as intravenous treatments given once weekly for 6 weeks: vinorelbine tartrate over 6-10 minutes and paclitaxel over 1 hour. Quality-of-life assessment and questionnaire administration are also listed as interventions.
Comparator
The registry describes a single-group study and does not list a separate control group. Allocation is recorded as NA, and the record notes that the arms are not a like-for-like control comparison. The treatment experience therefore cannot be interpreted as a randomized comparison against another regimen or against no treatment.
Primary question
The primary endpoint is progression-free survival, measured from first therapy until first documentation of clinical progression, relapse or death. The registry describes a follow-up period assessed up to 5 years and specifies Kaplan-Meier estimation. It does not report a median progression-free survival or its confidence interval in the information available in the registry record.
3. Trial Design
This completed study is registered as a phase II, single-group trial of vinorelbine tartrate and paclitaxel in older patients with advanced non-small cell lung cancer. The registry lists enrollment of 20. Recurrent non-small cell lung carcinoma and stage IV non-small cell lung cancer are among the registered conditions. The sponsor is the University of Nebraska. The record gives a start date of 2007-12-17 and a primary completion date of 2014-08-01.
The treatment group description specifies intravenous vinorelbine tartrate over 6-10 minutes and intravenous paclitaxel over 1 hour, once weekly for 6 weeks. The study also lists quality-of-life assessment and questionnaire administration. The registry records no masking. It does not describe a randomized allocation or a concurrent control group; allocation is recorded as NA, and the record cautions that arms are not a like-for-like control comparison. The main treatment description is one group, rather than an experimental group contrasted with a registered comparator.
The primary endpoint is progression-free survival. Secondary outcomes listed in the record are response rate based on RECIST criteria and incidence of greater-than-Grade 3 treatment-emergent non-hematological adverse events. The record lists 3 outcome measures and 1 analysis, but the specific numerical primary endpoint result is not reported in the registry record. The statistical plan beyond the stated Kaplan-Meier method is not reported in the registry record. Details of the intended analysis population and the handling of missing observations are also not reported in the registry record.
These design features define what can be learned from the posted results. A single-group study can describe outcomes observed among participants who received the regimen, but it does not provide a randomized estimate of how those outcomes compare with another treatment. The planned duration and endpoint definition describe the intended outcome measurement; they do not establish that follow-up was complete for every participant.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Treatment |
|---|---|
| STARTED | 20 |
| COMPLETED | 19 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Treatment |
|---|---|
| Adverse Event | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Treatment (Vinorelbine Tartrate, Paclitaxel) |
|---|---|---|
| Participants analysed | 20 | |
| Age, Customized | years | 76.9 (SD 3.6) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 16 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | Participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival., measured over Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival measures the time from first therapy until the first recorded occurrence of clinical progression, relapse or death. The registry describes follow-up assessed up to 5 years. It defines progression using RECIST v1.0: an increase of at least 20% in the sum of the longest diameter of target lesions, using the smallest recorded sum since treatment began as the reference, or the appearance of one or more new lesions.
This time-to-event endpoint combines disease progression and death into an outcome measured over time. It can therefore describe how long participants remain without a recorded event, rather than only whether an event occurred by a single fixed assessment. The registry states that the Kaplan-Meier method will be used to estimate the time-to-event distribution. In general, this method uses the event times and accounts for participants whose follow-up ends before an event is recorded, under assumptions about censoring.
The registry identifies the median and a 95% confidence interval as the intended summary. In general, the median is the time by which half of the estimated study population has experienced the event. A confidence interval describes uncertainty around an estimate; it does not itself indicate the probability that an individual participant will have a particular outcome. The numerical median and confidence interval are not reported in the registry record, so the observed endpoint cannot be quantified from the posted information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical limitation is that the registry record names progression-free survival as the primary endpoint but does not report a numerical result for it. There is no posted median, 95% confidence interval, or other numerical summary of progression-free survival in the record. Consequently, the endpoint definition and planned method can be explained, but the observed duration of progression-free survival and the precision of its estimate cannot be assessed from the registry record.
The study enrolled 20 participants and is registered as a single-group phase II trial. That design can provide descriptive information about outcomes in the group treated with vinorelbine tartrate and paclitaxel. Without a separate randomized comparator, however, the observed outcomes cannot establish how the same participants would have fared under another regimen. Differences from outcomes in another study would not, by themselves, be a randomized treatment contrast, because patient selection, follow-up, and other study features may differ.
The record describes Kaplan-Meier estimation for the primary time-to-event endpoint. In general, this approach estimates the event-time distribution while using information from participants whose follow-up ends before an event is observed. The estimate's reliability depends on the amount and pattern of follow-up and on the number of events. The registry record does not report the number of primary endpoint events, the number censored, or the numerical confidence interval. Those omissions prevent a direct assessment of how precisely the endpoint was estimated.
Safety information is reported separately. The adverse-event record lists 19 participants at risk for serious events and 6 affected, and it lists 19 at risk and 19 affected for other events. The listed serious-event terms include febrile neutropenia at 10.5%, and cardiac arrest, ischemic encephalopathy, acute hypoxic respiratory failure and pulmonary infiltrates at 5.3% each. These are descriptive entries, not a randomized safety comparison. The record also lists 16 deaths, but does not establish in the information described whether those deaths were caused by treatment, related to the underlying disease, or occurred during a particular risk period.
Overall, the posted information supports a description of the study design, endpoint definition, treatment schedule and selected safety entries. It does not support a numerical conclusion about the primary endpoint's observed value or a causal comparison of treatment outcomes.
9. Statistical Methods Explained
The registry specifies a time-to-event primary endpoint and states that the Kaplan-Meier method will be used. The outcome begins at first therapy and ends at the first recorded progression, relapse or death. The progression definition follows RECIST v1.0, as described in the endpoint definition. This discussion explains the statistical ideas behind that approach; it does not add a result that is absent from the registry record.
What does a time-to-event endpoint capture?
In general, a time-to-event endpoint retains information about when an event occurs, not merely whether it occurred. For progression-free survival, the event is the first of the endpoint events defined in the record: clinical progression, relapse or death. Participants who have no recorded event by the end of their observed follow-up contribute information up to that point. The registry specifies assessment up to 5 years, but does not report how long each participant was followed or whether every participant completed follow-up.
How does Kaplan-Meier estimation work?
In general, the Kaplan-Meier method estimates the probability of remaining event-free over time. It incorporates event times and allows participants to be censored when observation ends without a recorded event. Censoring is not the same as an event: it indicates that the event status is not observed after the participant's last known follow-up. The method relies on assumptions about how censoring relates to the chance of experiencing the event. The registry record does not report details of censoring patterns or checks of those assumptions.
The median from a Kaplan-Meier curve is the time at which the estimated event-free proportion reaches one half, if the curve reaches that point within observed follow-up. In general, a median may be difficult to estimate when follow-up is limited or when too few events have occurred. The record identifies the median as the intended summary, together with a 95% confidence interval, but does not give either numerical result. Without those values, neither the estimated time nor its precision can be described.
What does a confidence interval communicate?
In general, a 95% confidence interval gives a range of values compatible with the observed data under the statistical method and its assumptions. A narrower interval indicates greater precision than a wider interval, but the interval does not remove possible bias from study design, endpoint assessment or missing follow-up. A confidence interval is also not an individual prediction. Because no primary endpoint interval is reported in the registry record, the precision of the median cannot be evaluated.
What can the design establish?
The trial is registered as single-group, with no masking and no separate control group listed. In general, single-group outcome summaries describe what occurred among participants in that group. They do not isolate the effect of treatment from other influences, such as the natural course of disease or differences in who entered the study. A randomized comparator can support a more direct treatment contrast by balancing factors across groups; no such comparator is described in this record.
The registry lists secondary outcomes for response rate based on RECIST criteria and incidence of greater-than-Grade 3 treatment-emergent non-hematological adverse events. It does not report numerical results for these outcomes in the registry record for this analysis. The presence of named outcomes does not establish what statistical method was used for each one, nor whether a particular outcome was fully assessed.
How should planning illustrations be understood?
In general, sample-size planning asks how many observations may be needed to detect a specified effect under stated assumptions. The record's planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; for time-to-event illustrations, the total number of events is the quantity described. The assumptions state that the effect to detect is a stated fraction of the observed effect. These are planning illustrations, not evidence that the trial was designed with those assumptions, and not observed power. The registry does not report a sample-size justification for this single-group study. A two-arm planning illustration should not be mistaken for an actual randomized comparison in this trial.
More broadly, statistical precision depends on the number of participants, the number and timing of events, and the completeness of follow-up. Enrollment of 20 is reported, but enrollment alone does not reveal how many participants contributed to a particular analysis or how many primary endpoint events occurred. Those details, along with the numerical primary endpoint estimate, are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The record lists multiple outcomes, including progression-free survival, response rate based on RECIST criteria, and incidence of greater-than-Grade 3 treatment-emergent non-hematological adverse events. When several outcomes or analyses are examined, the chance of obtaining an apparently notable result by chance can increase. In general, a statistical plan may address this by identifying a primary outcome in advance and specifying whether and how other tests will be adjusted or interpreted. The registry identifies progression-free survival as primary, but a multiplicity strategy is not reported in the registry record.
The record lists 3 outcome measures and 1 analysis. It does not provide a detailed statistical analysis plan, the complete set of analyses, or information about whether interim analyses were planned or conducted. Those details are not reported in the registry record and cannot be inferred from the number of listed outcomes or analyses.
Missing-data methods and analysis populations are also not described in the record available for this analysis. It does not state whether the primary analysis included all enrolled participants, only participants who received treatment, or another defined group. It also does not describe how missing endpoint assessments, withdrawal, or incomplete follow-up were handled. For a time-to-event outcome, follow-up ending without a recorded event may be treated as censoring under a specified approach, but the record does not give participant-level follow-up or censoring details.
These omissions matter for interpretation because outcome estimates can depend on which participants are included and how incomplete observations are treated. The registry record identifies the endpoint and intended Kaplan-Meier method, but those details alone do not establish the analysis population, the handling of missing data, or the approach to multiple outcomes.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Treatment (Vinorelbine Tartrate, Paclitaxel) | 6 | 19 | 31.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment (Vinorelbine Tartrate, Paclitaxel) | 16 of 20 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Treatment (Vinorelbine Tartrate, Paclitaxel) | 19 of 19 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment (Vinorelbine Tartrate, Paclitaxel) |
|---|---|---|
| Febrile neutropenia | Infections and infestations | 2 of 19 |
| Cardiac arrest | Cardiac disorders | 1 of 19 |
| Ischemic encephalopathy | Nervous system disorders | 1 of 19 |
| Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 19 |
| pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | 1 of 19 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment (Vinorelbine Tartrate, Paclitaxel) |
|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | 5 of 19 |
| pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | 5 of 19 |
| hypoxemia | Respiratory, thoracic and mediastinal disorders | 5 of 19 |
| Anemia | Blood and lymphatic system disorders | 4 of 19 |
| Neutropenia | Blood and lymphatic system disorders | 4 of 19 |
| back pain | Musculoskeletal and connective tissue disorders | 2 of 19 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 2 of 19 |
| Lymphopenia | Blood and lymphatic system disorders | 1 of 19 |
| Febrile neutropenia | Infections and infestations | 1 of 19 |
| Anorexia | Metabolism and nutrition disorders | 1 of 19 |
Serious events with the highest arm-level rate: febrile neutropenia (10.5%), cardiac arrest (5.3%), ischemic encephalopathy (5.3%), acute hypoxic respiratory failure (5.3%), pulmonary infiltrates (5.3%).
The adverse-event record lists one treatment group, titled Treatment (Vinorelbine Tartrate, Paclitaxel). For serious adverse events, 19 participants are listed as at risk and 6 as affected. For other adverse events, the record lists 19 at risk and 19 affected. It also lists 16 deaths. These entries should be read as descriptive counts in the registry record, not as comparisons between treatment groups.
The listed serious-event terms and percentages are febrile neutropenia, 10.5%; cardiac arrest, 5.3%; ischemic encephalopathy, 5.3%; acute hypoxic respiratory failure, 5.3%; and pulmonary infiltrates, 5.3%. The record does not provide event-level detail here, such as timing, duration, recurrence, or whether an individual experienced more than one listed event. The percentages should therefore be treated as posted descriptions, not as a basis for reconstructing additional counts.
The death count does not, by itself, establish that deaths were caused by treatment. The record does not specify a causal attribution or a risk period for those deaths in the information described. Safety interpretation is further limited by the absence of a comparison group and by the fact that 19, rather than the total enrollment of 20, is listed as at risk in the adverse-event group. The reason for that difference is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed phase II, single-group study evaluated weekly vinorelbine tartrate and paclitaxel in older patients with advanced non-small cell lung cancer. It describes the treatment schedule and identifies progression-free survival as the primary endpoint. It also gives the endpoint definition, states that Kaplan-Meier estimation was planned, and lists selected safety information.
Those details do not reveal the numerical primary endpoint outcome. A median progression-free survival and its 95% confidence interval are not reported in the registry record. Without them, it is not possible to characterize the observed endpoint value or its precision from this record. The named response and adverse-event outcomes also do not, on their own, provide numerical evidence of their observed results.
Even if an outcome estimate were available, the single-group design would describe what happened among participants in the treated group rather than provide a randomized contrast. It would not establish what would have happened to the same participants under a different treatment. The study therefore cannot support a direct causal comparison against an unregistered control group or another regimen based solely on its design.
The safety entries likewise need a descriptive reading. The reported counts and percentages identify events recorded in the treatment group, but do not establish why an event occurred or whether the rate would differ under another treatment. The listed deaths are not identified as treatment-related in the information.
In general, clinical interpretation of a trial requires attention to the outcome definition, analysis method, precision, completeness of follow-up and study design. The record provides some of this context, but key outcome results and analysis details are not reported in the registry record. Accordingly, the defensible interpretation is limited to the registered design and the descriptive information actually posted.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it pairs a time-to-event endpoint with a single-group design. Progression-free survival is defined as time from first therapy to progression, relapse or death, and the registry specifies Kaplan-Meier estimation. That combination makes the distinction between an endpoint definition and a numerical endpoint result especially important: a planned method does not tell readers what the observed estimate was, or how precise it was.
The study also illustrates why design determines the scope of a statistical conclusion. A single group can be described using event-time and safety summaries, but there is no concurrent randomized control group in the registry record to anchor a treatment comparison. The design therefore does not separate treatment effects from other influences on observed outcomes. This is a limit of interpretation, not a calculation problem.
The safety entries demonstrate a related distinction. Counts and percentages can describe events recorded among participants at risk, but without a comparator they cannot show whether the frequency was higher or lower than it would have been under another regimen. Nor do the listed deaths establish treatment causation.
Finally, this record shows why completeness of reporting matters. It identifies the primary endpoint, its intended method and the planned follow-up horizon, yet does not report the numerical primary endpoint result, its confidence interval, or important details of missing-data handling and analysis populations. Statistical interpretation depends not only on selecting a suitable method but also on reporting the estimate, its uncertainty and the conditions under which it was obtained.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation is the absence of a numerical progression-free survival result. Although the registry identifies the median and 95% confidence interval as the intended summaries, neither is reported in the registry record. The number of primary endpoint events, the number censored, and the distribution of follow-up are also not reported. The endpoint's observed magnitude and precision therefore cannot be assessed.
The study is registered as a single-group trial with no separate control group. Its outcome summaries cannot provide a randomized comparison with another treatment. No masking is recorded, and the record does not describe procedures for independent endpoint review. Whether progression assessments were centrally reviewed or how assessment timing was standardized is not reported in the registry record.
The registry describes enrollment of 20 participants, while the adverse-event group lists 19 at risk. The reason for this difference is not reported. The record also does not describe which participants were included in each outcome analysis, how missing observations or incomplete follow-up were handled, or whether all enrolled participants received treatment.
Other reporting details are absent, including the numerical results for the listed secondary outcomes, a detailed statistical analysis plan, a multiplicity approach, and the sample-size justification. The record's planning assumptions do not establish the study's original design rationale. The duration and completeness of individual follow-up are not available in the record. These limitations constrain both assessment of statistical reliability and interpretation of the descriptive safety information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer — NCT00602797.
- Registry record last updated 2023-09-26; status last verified 2023-09.
- Results first posted 2018-05-17.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed phase II, single-group study of weekly vinorelbine tartrate and paclitaxel in older patients with advanced non-small cell lung cancer. Enrollment was 20. The treatment schedule specifies intravenous administration of both drugs once weekly for 6 weeks. The primary endpoint is progression-free survival, measured from first therapy until progression, relapse or death, with progression defined using RECIST v1.0. Kaplan-Meier estimation is the stated method.
The record lists response rate based on RECIST criteria and incidence of greater-than-Grade 3 treatment-emergent non-hematological adverse events as secondary outcomes. It reports selected adverse-event counts and percentages, but does not report the numerical primary endpoint result or its 95% confidence interval. Analysis-population details, missing-data handling, a multiplicity strategy and a sample-size justification are not reported in the registry record. The single-group design does not provide a randomized treatment comparison.