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 Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer (NCT00043108), a na phase 2 study. The primary outcome is Toxic Death Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00043108 |
| Phase | Phase 2 |
| Condition | Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Fox Chase Cancer Center |
| Results posted | Yes |
2. Clinical Question
The study examined a treatment approach combining chemotherapy, radiation therapy, and surgery for patients with newly diagnosed, locally advanced non-small cell lung cancer described as potentially resectable. The registry record lists paclitaxel and carboplatin, thoracic radiation therapy, and conventional surgery as interventions. Its stated rationale describes chemotherapy and radiation therapy before and after surgery, but the recorded treatment-arm description specifically gives thoracic radiation therapy with weekly paclitaxel and carboplatin. The record does not give a complete sequence for every intervention.
Population
Patients with newly diagnosed locally advanced non-small cell lung cancer. The trial description characterizes the disease as potentially resectable. More detailed eligibility criteria are not reported in the registry record.
Intervention
A treatment approach involving thoracic radiation therapy, paclitaxel, carboplatin, and conventional surgery. The treatment-arm description specifies thoracic RT (50.4 Gy/1.8 Gy Fx), paclitaxel (50mg/m2/weekly X 6), and carboplatin (AUC 2/weekly X 6).
Comparator
No concurrent control group is listed. The registry record identifies the study as single-group, with allocation recorded as NA and masking as none. It therefore does not provide a randomized, like-for-like comparison.
Primary question
The primary endpoint is toxic death rate over 5 years, expressed as a count of participants. The registry record does not report the primary endpoint result or an analysis of it, so the endpoint’s observed value cannot be described.
The record also lists survival, event-free survival, and pathologic complete remission as secondary outcomes. It does not report results for those outcomes in the information available for this analysis. As a result, the clinical question can be described from the study’s stated purpose and outcomes, but the record does not establish what happened to participants on the primary or secondary endpoints.
3. Trial Design
This was a phase II study registered as NCT00043108 and sponsored by Fox Chase Cancer Center. The study is marked completed. Its recorded start is 2002-07, and its primary completion is 2016-12. Enrollment is listed as 19 participants.
The design is single-group, with allocation recorded as NA and masking as none. The record lists a Treatment group rather than a control group. This structure is important when interpreting the study: outcome counts describe participants in the treatment group, but there is no concurrent comparison group from which to estimate a randomized treatment contrast. Historical or external comparisons are not reported in the registry record.
Interventions include carboplatin, paclitaxel, conventional surgery, and radiation therapy. The treatment-arm description specifies thoracic RT (50.4 Gy/1.8 Gy Fx), paclitaxel (50mg/m2/weekly X 6), and carboplatin (AUC 2/weekly X 6). The brief study description discusses combining chemotherapy with radiation therapy and surgery, including treatment before and after surgery. The exact timing and sequence of every intervention are not fully described in the registry record.
The primary endpoint is Toxic Death Rate, measured as a count of participants over 5 years. Secondary outcomes listed are survival, event-free survival, and pathologic complete remission. The record identifies 5 outcome measures, but does not provide the full set of outcome names or outcome analyses in the information available for this account. Details such as eligibility criteria, the statistical analysis plan, and the intended analysis population are not reported in the registry record.
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 | 19 |
| COMPLETED | 19 |
| NOT COMPLETED | 0 |
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 |
|---|---|---|
| Participants analysed | 19 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 10 |
| Age, Categorical: >=65 years | Participants | 9 |
| Sex: Female, Male: Female | Participants | 9 |
| Sex: Female, Male: Male | Participants | 10 |
| Race/Ethnicity, Customized: White Non-Hispanic | Participants | 17 |
| Race/Ethnicity, Customized: Black or African American | Participants | 2 |
| Region of Enrollment: United States | participants | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Toxic Death Rate, measured over 5 years.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled Toxic Death Rate. Its measurement is a count of participants, and its stated timeframe is 5 years. A count endpoint records how many participants meet the event definition during the specified observation period. It is not itself a comparison of treatment groups, and without a reported result it does not indicate how often the event occurred in this study.
In general, toxicity-related deaths are used as a safety endpoint because they capture a serious outcome that may be attributed to treatment toxicity under the study’s definitions. Interpretation depends on how a toxic death is defined, how attribution is assessed, and how follow-up is handled. Those operational details are not reported in the registry record, so the endpoint label alone does not specify how deaths were classified.
The registry record does not report a primary endpoint value or an analysis of toxic death rate. A separate safety listing gives a deaths count, but that field is not identified as toxic deaths. It cannot be substituted for the primary endpoint result or used to determine whether any death was attributed to treatment. The endpoint’s intended clinical meaning can therefore be described, but its observed result and precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a clinically serious primary endpoint: toxic death rate over 5 years, measured as a count of participants. However, it does not report the primary endpoint result or an analysis of that endpoint. The record also lists secondary outcomes—survival, event-free survival, and pathologic complete remission—but does not report their results in the information available for this analysis. Thus, no estimate of the study’s observed outcome on these measures can be interpreted.
The design limits what a treatment effect could mean even if outcome estimates were available. This was a single-group study, with no concurrent comparator listed. A count or proportion in the treatment group could describe what was observed among participants under the study’s follow-up and definitions, but it could not by itself show how outcomes would have differed under another treatment or no study treatment. Differences from other populations or studies would also be difficult to interpret without details about eligibility, follow-up, outcome definitions, and analysis methods.
The registry lists 19 enrolled participants. That enrollment figure describes the recorded study size; it does not establish how many participants were included in each endpoint analysis or completed follow-up. Analysis populations and endpoint-specific denominators are not reported in the registry record. For a time-to-event outcome, interpretation would also depend on follow-up duration and censoring, details that are not stated in the available record.
A separate safety listing records 0 participants affected by serious adverse events and 0 affected by other adverse events, with 19 at risk in each category. It also records 14 deaths. These entries do not report whether the deaths were toxic, do not identify their causes, and do not give a timing or attribution breakdown. The deaths figure must therefore be kept distinct from the primary endpoint, rather than treated as its result. The adverse-event figures are descriptive registry entries and do not establish that no safety events occurred beyond the categories or reporting captured in that listing.
The posted information supports a description of the study design, intervention, planned endpoint, and selected safety counts. It does not support a conclusion about the value of the primary endpoint, the secondary outcomes, or a causal treatment effect. Confidence intervals, p-values, and adjusted estimates are not reported in the registry record. Without such outcome analyses, the precision and statistical uncertainty of treatment-group outcomes cannot be assessed.
9. Statistical Methods Explained
The methods information recorded for this study is limited. The study is identified as phase II and single-group, and the primary endpoint is a participant count for Toxic Death Rate over 5 years. The registry record does not report the statistical analysis plan, so the intended estimation method, hypothesis tests, covariate adjustments, and handling of follow-up cannot be established from this information.
What does a count endpoint describe?
In general, a count endpoint records the number of participants who experience an event meeting a specified definition. A count is straightforward to interpret as an event total, but the total depends on the number of participants observed and the period during which they are followed. To compare event occurrence across settings, analysts often also need a denominator, consistent follow-up information, and a clear event definition. The registry identifies the primary endpoint’s unit as participants and its timeframe as 5 years, but does not report an endpoint count, an analysis denominator, or the operational definition of toxic death.
A count should not be mistaken for a rate unless the analysis defines and reports the relevant denominator or person-time basis. The endpoint title uses the word “rate,” while its recorded parameter is a count of participants. The registry record does not explain whether the planned analysis would convert that count to a rate or how it would account for different follow-up durations. Consequently, the label and measurement field do not provide enough detail to reconstruct an analysis.
What can a single-group design estimate?
In general, a single-group study can describe outcomes observed in the enrolled group. Without a concurrent comparator, it does not directly estimate a randomized difference between treatment strategies. An observed outcome may reflect the treatment approach, the participants’ underlying health and disease, other care, follow-up practices, and chance. A causal comparison would require additional design or analysis assumptions that are not reported in the registry record.
Here, allocation is listed as NA, masking as none, and the model as single-group. These features mean that outcome interpretation should remain descriptive unless other methods are documented. The record does not report a control group, randomization procedure, blinded outcome assessment, or adjusted analysis. It also does not state whether the toxicity endpoint was adjudicated independently or how attribution was determined.
How should uncertainty be understood?
In general, a confidence interval describes a range of values compatible with the data under a specified statistical method. Its width reflects uncertainty, including uncertainty arising from limited event information. A p-value, when used, addresses compatibility between data and a specified null hypothesis under model assumptions; it is not a measure of clinical importance. Neither a confidence interval nor a p-value is reported for the primary endpoint in the registry record. The record identifies 0 outcome analyses, so there is no reported inferential result to interpret.
For count data, general modeling choices may include methods for event counts or methods that model an event probability. Choice depends on the design, the endpoint definition, the exposure or follow-up structure, and features such as variation beyond what a simple model expects. Over-dispersion is a general concern when observed count variability exceeds a model’s assumptions; accounting for it can affect uncertainty estimates. The registry record does not state that any count model, over-dispersion assessment, or other inferential approach was used.
What does the planning illustration represent?
In general, sample-size calculations are prospective planning tools that depend on assumptions about the target effect, variability, significance level, allocation, and analysis method. They do not measure the probability that a completed study has produced a true finding. The planning assumptions associated with this record describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with a target effect expressed as a fraction of an observed effect. Those are illustration assumptions, not a description of the actual single-group study design.
Because the trial is single-group, the assumed equal allocation between two arms does not match the recorded design. Any sample-size values generated under those assumptions should be read only as hypothetical planning illustrations, not as the study’s protocol justification or as observed power. The registry record does not report the trial’s own sample-size justification or establish that these assumptions were part of its design.
In general, observed power calculated after a study from its estimated effect adds little information beyond the effect estimate and its uncertainty. A planning illustration based on an observed effect should not be interpreted as observed power. No endpoint estimate is reported for the primary outcome, and the record does not provide the trial’s own prespecified assumptions for a power calculation.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists several outcomes, including Toxic Death Rate as the primary endpoint and survival, event-free survival, and pathologic complete remission as secondary outcomes. It also identifies 5 outcome measures, but the full set of outcome names and their analyses are not reported in the information available for this analysis. The presence of multiple outcomes raises a general multiplicity issue: examining several endpoints or analyses can increase the chance of finding an apparently notable result by chance. Statistical plans may address this through prespecified endpoint hierarchies or adjustment methods, but the registry record does not report whether any such approach was planned or used.
The record identifies 0 outcome analyses. It therefore does not provide reported endpoint estimates, p-values, confidence intervals, or multiplicity adjustments to assess. The analysis plan, including which endpoints were confirmatory or exploratory and how any repeated testing would be handled, is not reported in the registry record. No claim about statistical significance or multiplicity control can be made from the endpoint list alone.
Missing-data procedures and analysis populations are also not reported in the registry record. It is not stated how participants with incomplete follow-up, unavailable endpoint assessments, or protocol deviations would be handled. The enrollment figure does not establish how many participants contributed data to each outcome analysis. It is also not stated whether outcomes would be analyzed according to enrollment, treatment received, or another defined population. These omissions matter because exclusions and incomplete follow-up can change which participants contribute to an estimate and how representative it is of the enrolled group.
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 | 0 | 19 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment | 14 of 19 |
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 | 0 of 19 |
The adverse-event listing records 19 at risk and 0 affected for serious adverse events, and 19 at risk and 0 affected for other adverse events. These are counts in the registry’s safety categories; they should be read as entries for the recorded group and not as a complete account of every possible safety outcome. Definitions, collection procedures, event timing, and the extent of follow-up are not reported in the registry record.
The same listing records 14 deaths. The deaths field is distinct from the serious and other adverse-event affected counts, and the registry record does not identify these deaths as toxic deaths. It does not report their causes, timing, relationship to treatment, or whether they occurred within the primary endpoint’s 5-year timeframe. Accordingly, the death count cannot be used as the value of the Toxic Death Rate endpoint.
These entries are descriptive, not a comparison with another treatment group. Because the study is single-group, the safety listing cannot establish how event occurrence would compare under an alternative approach. The registry record also does not provide event-level details or a statistical analysis of safety outcomes. Any interpretation should retain those distinctions between event categories, the deaths field, and the defined primary endpoint.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase II, single-group study evaluated a combined treatment approach for locally advanced, potentially resectable non-small cell lung cancer. It identifies Toxic Death Rate over 5 years as the primary endpoint and lists survival, event-free survival, and pathologic complete remission as secondary outcomes. It also records enrollment of 19 participants and selected safety counts. These registry entries describe the study and its registered outcome framework.
The record does not provide the primary endpoint result or analyses of the listed outcomes. It therefore does not show the observed toxic death count, the precision of any endpoint estimate, or whether outcome patterns differed from what might be expected under another approach. The separate deaths entry cannot fill this gap because the registry does not classify those deaths as toxic deaths or give their relationship to the endpoint timeframe.
Even if a treatment-group outcome estimate were available, the single-group design would support description rather than a direct randomized comparison. An outcome observed in participants cannot, by itself, establish what would have happened to comparable participants under a different treatment strategy. No control group or adjusted comparison is reported in the registry record.
In general, an absence of a reported statistical analysis should not be read as evidence that an event did not occur or that a treatment effect is absent. It means the record does not supply the information needed to evaluate that result. The findings and their uncertainty cannot be inferred from the study title, rationale, enrollment, or intervention description. The registry record supports a limited account of design and safety entries, not a conclusion about treatment effectiveness or a complete assessment of safety.
13. Why This Trial Matters Statistically
This study illustrates why design and endpoint definitions matter when reading clinical-trial results. The primary endpoint is named Toxic Death Rate, but its recorded measurement is a count of participants over 5 years. The registry does not explain how toxic deaths were defined or attributed, and it does not report the endpoint result. A clear endpoint label is not a substitute for an operational definition and an observed estimate.
The single-group design is also central to statistical interpretation. It can describe outcomes among enrolled participants, but it does not provide a concurrent randomized comparator for estimating a treatment contrast. This distinction remains important even when a study addresses a serious clinical question and includes several treatment modalities. The design determines which claims can be supported by the data and which require assumptions beyond the registry record.
The safety fields show why similarly worded counts should not be conflated. The adverse-event listing includes affected counts for serious and other events, alongside a separate deaths count. The record does not state that the deaths were toxic or that they correspond to the primary endpoint. Keeping outcome definitions and data fields separate prevents a descriptive count from being misrepresented as an endpoint estimate.
Finally, the record demonstrates the difference between a trial’s design and a hypothetical planning illustration. The stated sample-size assumptions use equal allocation between two arms, whereas the registered study is single-group. Those assumptions do not document the trial’s original design rationale. Statistical interpretation depends not only on the numbers listed, but also on whether the assumptions and analysis match the actual study design.
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 registry record does not report the primary endpoint result, outcome analyses, confidence intervals, p-values, or adjusted estimates. Although it lists secondary outcomes and identifies 5 outcome measures, the full outcome information and analyses are not available in this record. This prevents assessment of the observed results and their statistical precision.
The study is single-group and has no concurrent comparator listed. This limits interpretation to outcomes observed in the treatment group and does not support a direct randomized comparison. The record also does not report eligibility criteria in detail, so the characteristics of the population to which the study might apply cannot be fully assessed.
Important methodological details are not reported in the registry record, including the statistical analysis plan, endpoint definitions beyond the primary title and measurement, analysis populations, missing-data methods, follow-up handling, and any multiplicity strategy. The timing and sequence of all interventions are not fully specified in the treatment description. These gaps make it difficult to assess how outcomes were measured, who contributed to each analysis, and how uncertainty was calculated.
The safety listing gives counts for adverse-event categories and deaths but does not provide event-level details, causes, attribution, timing, or a link between deaths and the primary endpoint. The deaths count therefore cannot be treated as a toxic-death count. In addition, the hypothetical planning assumptions describe equal allocation between two arms, which does not match the recorded single-group design; they do not establish the trial’s own sample-size justification.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer — NCT00043108.
- Registry record last updated 2022-02-03; status last verified 2022-01.
- Results first posted 2022-02-03.
- 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
NCT00043108 is a completed phase II, single-group study sponsored by Fox Chase Cancer Center. The record lists enrollment of 19 participants, with a start of 2002-07 and primary completion of 2016-12. The study concerned chemotherapy, radiation therapy, and surgery for newly diagnosed locally advanced non-small cell lung cancer described as potentially resectable.
The treatment description includes thoracic RT (50.4 Gy/1.8 Gy Fx), paclitaxel (50mg/m2/weekly X 6), and carboplatin (AUC 2/weekly X 6), with conventional surgery also listed as an intervention. The primary endpoint is Toxic Death Rate, measured as a count of participants over 5 years. Secondary outcomes listed include survival, event-free survival, and pathologic complete remission.
The registry record does not report outcome analyses for the primary or secondary endpoints. A safety listing records 0 affected for serious events, 0 affected for other events, and 14 deaths; the deaths are not identified as toxic deaths. The record does not report a concurrent comparator, analysis populations, missing-data methods, or the statistical analysis plan.