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 Navelbine And Radiotherapy in Locally Advanced Lung Cancer (NCT00887783), a randomized phase 2 study. The primary outcome is Local Failure Free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00887783 |
| Phase | Phase 2 |
| Condition | Non-small Cell Lung Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 117 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Odense University Hospital |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with inoperable, locally advanced stage IIB-IIIB non-small cell lung cancer who met the general criteria for curatively intended irradiation. The brief summary says participants completed induction chemotherapy before inclusion and that randomization took place only when an acceptable dose plan could be obtained. The primary outcome was analyzed in the intention-to-treat population.
Intervention
One randomized group received oral Navelbine, identified as vinorelbine, with radiotherapy to 60 Gy. The arm title identifies this schedule as 60Gy/30F. The arm description also records two cycles of carboplatin and vinorelbine before randomization.
Comparator
The other randomized group received oral Navelbine with radiotherapy to 66 Gy. Its title identifies the schedule as 66Gy/33F. The description likewise records two cycles of carboplatin and vinorelbine before randomization. Both groups therefore received concurrent Navelbine and irradiation, with the registered radiation dose regimen differing between groups.
Primary question
The primary question was local failure-free survival after radiotherapy, assessed by CT or FDG-CT at 9 months after the first radiotherapy treatment. The registry record reports a median for each group but no hazard ratio, confidence interval, or other inferential estimate comparing the groups. The posted medians alone do not establish whether the regimens differ statistically or clinically.
3. Trial Design
This was a randomized, open-label, parallel-group phase II study. The registry record lists an enrollment of 117 and reports 58 participants in the 66 Gy group and 59 in the 60 Gy group for the primary outcome. The study status is completed. It was sponsored by Odense University Hospital.
The treatment pathway included induction chemotherapy followed by concurrent Navelbine and radiotherapy. The brief summary describes two courses of induction chemotherapy and says randomization occurred after induction, only when an acceptable dose plan could be obtained. The arm descriptions specify two cycles of carboplatin and vinorelbine before randomization. They then describe oral Navelbine with curatively intended irradiation. The group titles distinguish 66Gy/33F from 60Gy/30F.
The registry identifies the design as randomized, with no masking and a parallel model. Open-label treatment means that participants and care teams were not masked to assignment according to the registry design. The registry record does not describe further allocation procedures, concealment methods, or steps taken to reduce bias in outcome assessment. It does specify CT/FDG-CT measurement for the primary endpoint.
The primary outcome is local failure-free survival, analyzed as intention to treat. Five secondary outcomes are listed: early toxicity to concurrent vinorelbine and radiotherapy, local tumour control, overall survival, late toxicity, and disease free survival. The record lists six outcome measures in total. It does not report analyses for these outcomes in the registry record. The phase II designation describes the study phase; it does not by itself establish the precision or strength of evidence for a treatment difference.
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 | B: 66Gy/33F+Navelbine Oral 150 mg q3w | A: 60Gy/30F+Navelbine Oral 150 mg q3w |
|---|---|---|
| STARTED | 58 | 59 |
| COMPLETED | 58 | 59 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Analyzed as intention to treat
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 | B: 66Gy/33F+Navelbine Oral 150 mg q3w | A: 60Gy/30F+Navelbine Oral 150 mg q3w | Total |
|---|---|---|---|---|
| Participants analysed | 58 | 59 | 117 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 32 | 22 | 54 |
| Age, Categorical: >=65 years | Participants | 26 | 37 | 63 |
| Age, Continuous | years | 64.56 (44.38 to 79.39) | 66.63 (44.68 to 81.98) | 65.53 (44.38 to 81.98) |
| Sex: Female, Male: Female | Participants | 26 | 36 | 62 |
| Sex: Female, Male: Male | Participants | 32 | 23 | 55 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: Denmark | Participants | 58 | 59 | 117 |
6. Primary Endpoint
The registry lists the primary outcome as Local Failure Free Survival, measured over 9 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is titled local failure-free survival. Its registry description specifies assessment 9 months after the first radiotherapy treatment using CT or FDG-CT, with the analysis described as intention to treat. The reported measure is the median, in months, with a full range for each group. The registry lists a median of 9.4 months, with a full range from 2.8 to 67.0, in the 66 Gy group, and a median of 9.9 months, with a full range from 2.6 to 54.0, in the 60 Gy group.
In general, a time-to-event endpoint describes the time until a specified event, and a survival summary can account for when events occur rather than recording only whether an event was present at one fixed assessment. For local failure-free survival, the intended focus is local failure over time. However, the registry record does not define the event components, censoring rules, or detailed endpoint derivation. The stated assessment at 9 months and the reported medians in months should therefore be read as recorded, without assuming an unreported analysis method.
Imaging-based assessment is relevant because the outcome concerns local tumour failure. The registry names CT/FDG-CT but does not specify central review, reader masking, confirmation rules, or how indeterminate findings were handled. Those details affect how reproducible an imaging endpoint may be, so their absence limits interpretation of the endpoint definition.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results give a median local failure-free survival of 9.4 months in the group assigned to 66 Gy with oral Navelbine and 9.9 months in the group assigned to 60 Gy with oral Navelbine. The corresponding full ranges are 2.8 to 67.0 months and 2.6 to 54.0 months. The primary outcome counts are 58 and 59, respectively. These are descriptive summaries for the two randomized groups.
The registry record does not provide a hazard ratio, confidence interval, p-value, or other inferential estimate for the between-group comparison. It also indicates that values for a two-arm comparison were missing or not estimable for this median-time endpoint. As a result, the posted medians and ranges do not quantify the uncertainty around a treatment contrast. They cannot establish whether an observed difference is compatible with chance variation or whether the groups differ on the underlying time-to-event outcome.
A median is the point at which half of the analyzed observations are at or below the median and half are at or above it, subject to the method used to estimate the survival distribution. The registry does not describe that estimation method. A full range reports the lowest and highest observed or reported values, but it does not show the distribution of observations between those endpoints. It is not a confidence interval and does not describe the precision of the median.
The registry's primary outcome population is described as intention to treat. This generally means participants are analyzed according to randomized assignment, regardless of treatment actually received, but the record does not give further details about the implementation or handling of missing endpoint data. The reported group counts should not be taken as evidence that every enrolled participant had complete endpoint assessment.
The record lists five secondary outcomes, but no analyses are reported for them. It therefore does not support a broader conclusion based on those outcomes. Safety entries include counts of participants affected by serious and other adverse events and deaths; they are descriptive and do not, on their own, establish that an event was caused by a treatment or provide a controlled statistical comparison.
Overall, the posted results describe the trial groups and their recorded primary medians. They do not provide a quantified comparative effect or its uncertainty. Any conclusion about relative efficacy would require a suitable between-group analysis and further information about the endpoint methods and missing observations, none of which is reported in the registry record.
9. Statistical Methods Explained
The trial randomized participants to parallel treatment groups, but randomization alone does not communicate the size or precision of a treatment effect. To evaluate a comparative result, readers ordinarily need an estimate of the difference between groups and an uncertainty measure, often a confidence interval, alongside any test result. The registry record does not report those comparative statistics for the primary median-time endpoint.
What does a median time summarize?
In general, the median is a measure of the center of a distribution. In a time-to-event analysis, it represents the time by which half of the relevant population is estimated to have experienced the event, according to the analysis method. This can be useful when event times are skewed or when the distribution is not well described by an average. A median on its own does not show the shape of the event-time distribution, the precision of the estimate, or how the groups compare across the full follow-up period.
The posted primary measure is the median, with a full range. The ranges are 2.8 to 67.0 months for the group assigned to 66 Gy and 2.6 to 54.0 months for the group assigned to 60 Gy. In general, a range describes the observed extremes and is sensitive to values at either end. It is not a measure of sampling uncertainty. A confidence interval, by contrast, is an interval estimate intended to express uncertainty around a parameter under a specified statistical procedure. No confidence interval for either median, and no confidence interval for a between-group effect, is reported in the registry record.
Why is a time-to-event comparison different from comparing medians?
General time-to-event methods can use information about event timing and account for participants whose event status is not observed through the full follow-up period, using censoring rules. A hazard ratio is one possible comparative summary, but it requires a defined model and assumptions. The registry record does not report a hazard ratio or describe a time-to-event model, censoring rules, or a method for estimating the medians. The posted medians should not be treated as a substitute for an unreported hazard ratio or formal comparison.
The record states that values were missing or not estimable for a two-arm comparison of this median-time endpoint. Thus, the available figures support a descriptive reading by group, not a calculated inferential comparison. No recalculated treatment contrast is presented in the registry record. There is no discrepancy between a sponsor comparison and a recalculated comparison to resolve.
What does intention to treat mean?
As a general principle, intention-to-treat analysis retains participants in the group to which they were randomized. This preserves the comparison created by randomization and estimates the effect of assignment to the treatment strategy, rather than only the effect among participants who completed treatment as planned. The registry identifies the primary endpoint population as intention to treat, but does not describe deviations, exclusions, or missing-data handling. The precise operational details are therefore not reported in the registry record.
The study is listed as open label. In general, lack of masking can affect expectations, co-interventions, and judgments about outcomes, particularly when an endpoint involves assessment decisions. CT/FDG-CT is named for the primary endpoint, but the registry does not state whether image readers were masked to assignment or whether assessment was centrally reviewed. The extent to which open-label knowledge could affect endpoint ascertainment cannot be determined from the record.
How should planning calculations be read?
The sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The assumed target effect is described as a stated fraction of the observed effect. For time-to-event planning, the description specifies that the total number of events is the relevant quantity; for other outcomes, planning quantities are participants per arm. These are planning assumptions, not the trial's documented design rationale and not observed power.
The registry record does not report the trial's own sample-size justification, or a statistical plan linking the illustration to the actual enrollment. It does not report a planned target effect or explain whether planning was based on the primary endpoint. Sample-size calculations are conditional on assumptions about the effect, variability, event frequency, allocation, and analysis. A planning illustration therefore cannot establish that the completed study had a particular probability of detecting an effect. The registry record does not report a power calculation for the completed trial.
For a two-arm comparison, precision depends not only on the number randomized but also on the number and timing of events, the amount of censoring, and the analysis method. A relatively small phase II study may produce imprecise estimates, but the precision of this trial's primary comparison cannot be quantified without a reported comparative estimate and its uncertainty. No additional numerical precision measure can be inferred from the medians and full ranges alone.
What cannot be inferred from the registry results?
The record lists no analyses for the outcomes and does not report a multiplicity procedure, interim analyses, covariate adjustment, or a prespecified statistical analysis plan. These omissions do not demonstrate that such procedures were absent from the conduct of the study; they mean the details are not reported in the registry record. General statistical interpretation should therefore distinguish the recorded descriptive summaries from any analysis plan or comparative result that is not documented.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists six outcome measures in total: the primary local failure-free survival endpoint and five secondary outcomes. Those secondary outcomes are early toxicity to concurrent vinorelbine and radiotherapy, local tumour control, overall survival, late toxicity, and disease free survival. No analyses are reported for these outcomes in the registry record.
When a study examines multiple outcomes or makes multiple comparisons, the chance of at least one apparently notable result can increase. General methods for addressing multiplicity include prespecifying a primary outcome, adjusting significance thresholds, or describing secondary analyses as exploratory. The registry record identifies a primary endpoint but does not report a multiplicity strategy, a hierarchy among secondary outcomes, or an analysis plan. It is therefore not possible to determine how multiplicity was handled.
The primary endpoint is described as analyzed in the intention-to-treat population. The record does not describe the number of participants with missing imaging, the reasons for missing assessments, how missing endpoint information was handled, or whether sensitivity analyses were conducted. It also does not report missing-data procedures for the secondary outcomes. These details are not reported in the registry record, so the effect of missing data on the estimates cannot be assessed from the posted information.
The registry identifies an intention-to-treat population for the primary endpoint, but does not provide further analysis-population definitions, such as a per-protocol population or safety population. It does not describe exclusions after randomization or how treatment discontinuation was handled. The available participant counts are endpoint group counts, not evidence that every randomized participant contributed complete follow-up. No additional analysis populations or missing-data results should be assumed.
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 |
|---|---|---|---|
| B: 66Gy/33F+Navelbine Oral 150 mg q3w | 18 | 58 | 31.0% |
| A: 60Gy/30F+Navelbine Oral 150 mg q3w | 15 | 59 | 25.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| B: 66Gy/33F+Navelbine Oral 150 mg q3w | 41 of 58 |
| A: 60Gy/30F+Navelbine Oral 150 mg q3w | 44 of 59 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| B: 66Gy/33F+Navelbine Oral 150 mg q3w | 25 of 58 |
| A: 60Gy/30F+Navelbine Oral 150 mg q3w | 20 of 59 |
Most frequent serious adverse event terms
| Event term | Organ system | B: 66Gy/33F+Navelbine Oral 150 mg q3w | A: 60Gy/30F+Navelbine Oral 150 mg q3w |
|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 15 of 58 | 7 of 59 |
| Dysphagia | Gastrointestinal disorders | 8 of 58 | 8 of 59 |
| Atrial fibrilation | Blood and lymphatic system disorders | 0 of 58 | 2 of 59 |
| Herpes zoster | Skin and subcutaneous tissue disorders | 0 of 58 | 1 of 59 |
Most frequent non-serious adverse event terms
| Event term | Organ system | B: 66Gy/33F+Navelbine Oral 150 mg q3w | A: 60Gy/30F+Navelbine Oral 150 mg q3w |
|---|---|---|---|
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | 14 of 58 | 11 of 59 |
| Dysphagia | Gastrointestinal disorders | 7 of 58 | 6 of 59 |
| Leucopenia | Blood and lymphatic system disorders | 4 of 58 | 3 of 59 |
Serious events with the highest arm-level rate: dyspnoea (25.9%), dysphagia (13.8%), atrial fibrilation (3.4%), herpes zoster (1.7%).
The registry reports serious adverse events among 18 of 58 participants assigned to 66 Gy with oral Navelbine and 15 of 59 assigned to 60 Gy with oral Navelbine. It separately reports other adverse events among 25 of 58 and 20 of 59, respectively. Deaths are listed for 41 participants in the 66 Gy group and 44 in the 60 Gy group. The record does not specify in this summary the observation period for these counts or whether deaths were attributed to treatment, cancer, or another cause.
Listed serious adverse-event terms include dyspnoea at 25.9%, dysphagia at 13.8%, atrial fibrilation at 3.4%, and herpes zoster at 1.7%. The registry record does not clarify the denominator or group attribution for these percentages in the available summary. They should be read as posted terms and percentages, not as arm-specific comparisons.
These counts are descriptive. They do not establish causation, and the record does not provide a formal between-group safety analysis, uncertainty intervals, or details needed to interpret exposure time. Participants may experience more than one event, so counts of affected participants across categories should not be added or treated as mutually exclusive without further information. The registry record does not report those details.
12. What the Result Does, and Does Not, Mean
The posted primary results describe median local failure-free survival in two randomized groups receiving radiotherapy with oral Navelbine after induction chemotherapy. The median was 9.4 months in the 66 Gy group and 9.9 months in the 60 Gy group. The recorded full ranges were 2.8 to 67.0 months and 2.6 to 54.0 months, respectively. These figures summarize each group; they do not supply a formal estimate of the comparative effect.
The registry record does not report a hazard ratio, confidence interval, or p-value for the primary comparison, and states that a two-arm comparison was not estimable for this median-time endpoint. Without a comparative estimate and its uncertainty, the posted medians cannot establish whether the groups differ beyond chance variation, how large any underlying difference may be, or whether that difference is clinically important. The full ranges do not resolve this uncertainty because they describe extremes rather than precision.
The result also does not answer every question about treatment. The registry lists secondary outcomes related to toxicity, local tumour control, overall survival, late toxicity, and disease free survival, but reports no analyses for them. The safety counts provide descriptive information, but do not identify causal relationships or establish comparative safety. The details of missing endpoint data, censoring, imaging review, and the statistical analysis plan are not reported in the registry record.
In general, a randomized design aims to support a fair comparison by balancing prognostic factors through allocation. Its value for interpretation still depends on adequate follow-up, sound outcome measurement, transparent analysis, and sufficiently precise estimates. The posted record identifies randomization and an intention-to-treat primary population, but does not document enough comparative analysis to support a conclusion about relative treatment effects. The result is best understood as a limited descriptive account of the recorded primary outcome, not as proof that either regimen is superior or equivalent.
13. Why This Trial Matters Statistically
Statistically, this study illustrates why arm-specific summaries and treatment comparisons are not interchangeable. The registry reports a median and full range for each randomized group, but no inferential statistic for the difference between groups. A reader can describe the recorded summaries but cannot quantify the uncertainty of a comparative effect from those values alone.
The design also highlights the distinction between randomization and analysis. Random assignment supports a comparison in principle, while the intention-to-treat designation identifies the primary analysis population. Yet readers also need a clearly defined endpoint, a transparent account of missing observations and censoring, and an estimate with an uncertainty interval to judge what the comparison supports. The registry record does not report those details for the primary outcome.
The treatment sequence is relevant to the target question: participants completed induction chemotherapy before randomization, then received concurrent oral Navelbine with one of two radiation regimens. The comparison therefore concerns these treatment strategies in the selected population described by the record, including the requirement for an acceptable dose plan. It should not be generalized automatically to other populations or treatment settings.
The posted safety counts and the listed secondary outcomes also show why a complete interpretation requires more than the primary median. However, no secondary analyses are reported, and the adverse-event summary lacks detail on timing, attribution, and comparative uncertainty. The study is statistically informative as an example of a randomized phase II record whose descriptive outcomes are available but whose comparative result is not estimable from the posted information.
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 primary endpoint has limited methodological detail in the registry record. It names local failure-free survival and CT/FDG-CT assessment at 9 months after the first radiotherapy treatment, but does not define the event criteria, censoring rules, imaging review process, or the method used to estimate the median. Those omissions limit reproducibility and make it difficult to interpret the medians as time-to-event estimates.
No between-group hazard ratio, confidence interval, p-value, or other inferential comparison is reported. The record specifically indicates that a two-arm comparison was not estimable for the median-time endpoint. Consequently, the precision of any comparative effect cannot be evaluated. The full ranges are not substitutes for confidence intervals.
The study's brief summary says randomization occurred only when an acceptable dose plan could be obtained and after induction chemotherapy. This describes selection before randomization, but the registry does not give further detail on how many people were assessed or excluded before that point. The treatment descriptions include two cycles of carboplatin and vinorelbine before randomization, while the study summary describes two courses of induction chemotherapy. The registry does not report further details about treatment completion or adherence.
The record does not report a sample-size justification for the trial, a statistical analysis plan, interim analyses, multiplicity handling, missing-data methods, or secondary outcome analyses. It also does not explain the observation period or attribution for the adverse-event and death counts. These omissions limit assessment of bias, precision, and the scope of conclusions that can be drawn from the posted results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Navelbine And Radiotherapy in Locally Advanced Lung Cancer — NCT00887783.
- Registry record last updated 2022-05-17; status last verified 2022-04.
- Results first posted 2021-01-08.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
This completed, randomized, open-label, parallel-group phase II study enrolled 117 people with locally advanced non-small cell lung cancer. It compared oral Navelbine with radiotherapy to 66 Gy or 60 Gy after induction chemotherapy. The primary endpoint was local failure-free survival, described as assessed by CT/FDG-CT at 9 months after the first radiotherapy treatment and analyzed in the intention-to-treat population.
The registry reports median values of 9.4 months for the 66 Gy group and 9.9 months for the 60 Gy group, with full ranges of 2.8 to 67.0 and 2.6 to 54.0 months. A two-arm comparison was not estimable for this endpoint, and no comparative inferential estimate is reported. Five secondary outcomes are listed, but their analyses are not reported in the registry record.
Serious and other adverse-event counts and deaths are also recorded, without enough detail in the available summary to establish attribution or comparative risk. The posted information supports a descriptive account of the trial, but not a quantified conclusion about relative treatment effects.