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 Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer (NCT00079040), a na phase 2 study. The primary outcome is Percentage of Participants Alive and Progression-free (PF) at 6 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00079040 |
| Phase | Phase 2 |
| Condition | Extensive Stage Small Cell Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 65 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Patients with previously untreated extensive-stage small cell lung cancer. The registry record reports 65 enrolled participants and states that the per-protocol primary analysis included eligible, treated patients (n=63). The safety analysis included all treated patients, regardless of eligibility (n=64).
Intervention
The study evaluated cisplatin and etoposide together with bevacizumab. Cisplatin and etoposide are listed as drugs, and bevacizumab as a biological intervention. Laboratory biomarker analysis is also listed as an intervention.
Comparator
There was no separate comparison group: the study is recorded as single-group, with allocation listed as not applicable. The registry record therefore does not describe a randomized, concurrent control arm for estimating a between-group treatment contrast.
Primary question
The primary endpoint asks what percentage of participants were alive and progression-free at 6 months. Progression-free survival was defined as the interval from registration to documented progression or death without progression. The registry record does not report the endpoint estimate or its 95% confidence interval, so the observed progression-free rate cannot be stated from the record.
This is a question about the outcome observed in a treated group, not a direct comparison of the combination with another regimen. Overall survival and best objective response are listed as secondary outcomes, but their results are not reported in the registry record. The design and posted outcome information can describe the study population, endpoint definition, and available safety summaries; they do not provide a numerical estimate of comparative benefit.
3. Trial Design
This was a phase II study of cisplatin, etoposide, and bevacizumab for previously untreated extensive-stage small cell lung cancer. The registry record identifies the National Cancer Institute (NCI) as sponsor and lists the study status as completed. The recorded start was 2006-01, and primary completion was 2009-01. Enrollment was 65.
The design is listed as single-group, with allocation not applicable and no masking. In practical terms, the registry record describes one treatment group rather than randomized assignment to study and control arms. Results from this design can describe outcomes among participants receiving the regimen, but there is no concurrent randomized group in this study for estimating a treatment contrast.
The listed treatment combined cisplatin, etoposide, and bevacizumab. The record describes cisplatin administered intravenously on day 1 and etoposide intravenously on days 1–3, with treatment repeating every 21 days for up to 4 courses if there was no disease progression or unacceptable toxicity. The bevacizumab treatment description is incomplete in the registry record, so its full schedule cannot be stated.
The primary analysis population was eligible, treated patients (n=63), while the safety population included all treated patients regardless of eligibility (n=64). The registry record also reports 65 enrolled participants; it does not explain the disposition of every enrolled participant in the outcome summaries. Overall survival and best objective response are listed as secondary outcomes. Their numerical results and the detailed statistical analysis plan 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 | Cisplatin, Etoposide, Bevacizumab |
|---|---|
| STARTED | 65 |
| COMPLETED | 63 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Cisplatin, Etoposide, Bevacizumab |
|---|---|
| Withdrew before treatment | 1 |
| Ineligible | 1 |
Analysis population for the primary outcome, as defined in the registry: Per protocol, the analysis included all eligible, treated patients (n=63). The safety analysis included all treated patients, regardless of eligibility (n=64).
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 | Cisplatin, Etoposide, Bevacizumab |
|---|---|---|
| Participants analysed | 63 | |
| Age, Continuous | Years | 65 (45 to 83) |
| Sex: Female, Male: Female | Participants | 36 |
| Sex: Female, Male: Male | Participants | 27 |
| Region of Enrollment: United States | participants | 63 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Alive and Progression-free (PF) at 6 Months, measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage of Participants |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the percentage of participants alive and progression-free at 6 months. The registry definition treats progression-free survival as the interval, in months, from registration to documented disease progression or death without progression. Participants alive without progression at 6 months were included in the numerator used to calculate the progression-free rate.
This endpoint combines two clinically relevant events—documented progression and death without progression—into a time-to-event measure. Expressing the result at a specified follow-up time gives a fixed-time description of the proportion of the analyzed group meeting the endpoint. That can be useful in a phase II study when describing the observed course of participants receiving a regimen.
The registry lists the endpoint parameter as a mean and its dispersion as a 95% confidence interval. The primary population is described as all eligible, treated patients (n=63). However, the registry record does not report the numerical endpoint estimate or confidence limits. It also does not report detailed methods for handling censoring or participants without an observed six-month status. Consequently, the definition and target population are available, but the size and precision of the observed result cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the study question and primary endpoint, but it does not report the primary endpoint estimate or its 95% confidence interval. The percentage alive and progression-free at 6 months therefore cannot be quoted, and the precision of that estimate cannot be evaluated. The endpoint definition alone does not reveal how many participants met it.
The study is recorded as single-group, with allocation not applicable and no masking. Its outcome summaries can describe the treated group, but the design does not provide a randomized comparison with a concurrent control group. Thus, the registry information does not establish how outcomes would differ under another treatment or without the study regimen. This is a design limitation for comparative interpretation, not a reason to infer a result that is absent from the record.
The registry lists overall survival and best objective response as secondary outcomes. Their numerical results are not reported in the registry record. No conclusion about the direction or size of those outcomes can be drawn from their names alone. Likewise, the fact that the trial is marked completed does not supply the missing efficacy estimates.
The safety summary lists 64 participants at risk for serious adverse events and 49 affected, and 64 at risk for other adverse events and 63 affected. It also lists serious adverse-event terms with percentages. These figures describe the posted safety summary; they should not be confused with the primary efficacy endpoint or interpreted as comparative risks. The registry record does not report a death count in the adverse-event summary.
The outcome population and safety population are not identical: the primary analysis included eligible, treated patients (n=63), while the safety analysis included all treated patients (n=64). These denominators reflect different stated analysis populations. The record does not provide enough participant-level detail to reconcile all enrolled participants with each analysis set. Overall, the posted information supports a description of design, endpoint, analysis populations, and selected safety figures, but not a numerical account of the primary result or a comparative efficacy claim.
9. Statistical Methods Explained
The registry record characterizes the primary measure as the mean of a continuous measure and gives a 95% confidence interval as its dispersion. The outcome is expressed as the percentage of participants alive and progression-free at 6 months. The reported parameter label and the clinical wording identify what was intended to be summarized, but the detailed calculation procedure is not reported in the registry record.
What a confidence interval conveys
As a general statistical explanation, a confidence interval describes uncertainty around an estimated quantity under the assumptions of the method used to calculate it. A narrower interval indicates greater precision than a wider interval, while neither width nor location can be judged without the interval itself. In this trial, the registry record specifies a 95% confidence interval but gives no limits. The precision and range of plausible values associated with the primary estimate are therefore not assessable from the posted record.
How the endpoint is defined
The primary endpoint concerns status at 6 months, based on progression-free survival measured from registration. The event definition includes documented progression or death without progression. The registry states that participants alive without progression at 6 months were counted in the numerator when calculating the rate. This definition identifies the event and time origin. It does not, by itself, describe every analysis decision that may affect a time-to-event estimate, such as the handling of censoring or incomplete follow-up; those details are not reported in the registry record.
Why the design matters
As a general statistical point, a single-group study estimates outcomes within the group studied. Without a concurrent randomized comparator, differences from another treatment cannot be separated from differences in participant characteristics, care, follow-up, or other factors. This study is recorded as single-group, with allocation not applicable. Its primary endpoint can therefore be read as a planned description of the treated population, not as a randomized estimate of the effect relative to a control group.
The record identifies 65 enrolled participants, 63 eligible, treated participants in the per-protocol primary analysis, and 64 treated participants in the safety analysis. These are distinct stated populations. As a general principle, analysis populations should be read alongside the endpoint because exclusions or differing eligibility definitions can affect which participants contribute to a result. The record does not give a full accounting of every participant’s status or explain all differences among these populations.
What is not specified
The registry reports one analysis and three outcome measures, but this does not reveal which statistical tests or models were used. The detailed statistical plan, adjustment procedures, and methods for missing outcome data are not reported in the registry record. It would be inappropriate to infer a particular model, imputation method, or interim-analysis plan from the endpoint wording alone.
As a general explanation, over-dispersion matters when observed variability exceeds what a statistical model assumes; if that assumption is violated, standard errors and confidence intervals may be misleading unless the analysis accounts for it. The registry record does not report a model or information that would establish whether over-dispersion was assessed, so this issue cannot be evaluated for this trial.
The registry’s planning assumptions describe a hypothetical illustration based on the observed effect: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. These assumptions describe planning calculations, not the study’s single-group design, and they are not a report of observed power. The registry record does not report the trial’s own sample-size justification. Any planning illustration should not be mistaken for an observed treatment effect or evidence that the study had a particular probability of detecting one.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures and identifies progression-free status at 6 months as the primary endpoint. Overall survival and best objective response are listed as secondary outcomes. The number of recorded analyses is one, but that count does not specify which outcomes were included in the analysis or whether multiple statistical comparisons were made.
Whether the analysis adjusted for testing multiple outcomes, time points, or subgroups is not reported in the registry record. Without a stated multiplicity strategy and the associated results, the risk of inflated false-positive findings across multiple tests cannot be evaluated. The primary endpoint designation identifies the principal question, but it does not establish how any additional analyses were handled.
Methods for missing data are also not reported in the registry record. The endpoint definition specifies how participants alive without progression at 6 months contributed to the numerator, but it does not describe what happened to participants whose progression or vital status was unknown, or how censoring was handled in the calculation. No imputation or sensitivity-analysis approach is described.
The stated analysis populations differ: the primary analysis included eligible, treated patients (n=63), and the safety analysis included all treated patients regardless of eligibility (n=64). The record does not give enough detail to establish why each enrolled participant was or was not included in these populations. The trial’s interim-analysis plan and detailed statistical plan are not reported in the registry record. These omissions limit assessment of the analysis decisions, but they do not justify assuming that a particular method was or was not used.
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 |
|---|---|---|---|
| Cisplatin, Etoposide, Bevacizumab | 49 | 64 | 76.6% |
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 |
|---|---|
| Cisplatin, Etoposide, Bevacizumab | 63 of 64 |
Most frequent serious adverse event terms
| Event term | Organ system | Cisplatin, Etoposide, Bevacizumab |
|---|---|---|
| Low Neutrophils | Blood and lymphatic system disorders | 37 of 64 |
| Low Leukocytes | Blood and lymphatic system disorders | 19 of 64 |
| Low Platelets | Blood and lymphatic system disorders | 9 of 64 |
| Fatigue | General disorders | 8 of 64 |
| Hyponatremia | Metabolism and nutrition disorders | 7 of 64 |
| Hypertension | Cardiac disorders | 5 of 64 |
| Low Hemoglobin | Blood and lymphatic system disorders | 3 of 64 |
| Dehydration | Gastrointestinal disorders | 3 of 64 |
| Febrile Neutropenia | Infections and infestations | 3 of 64 |
| Joint, pain | Musculoskeletal and connective tissue disorders | 3 of 64 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cisplatin, Etoposide, Bevacizumab |
|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | 47 of 64 |
| Nausea | Gastrointestinal disorders | 43 of 64 |
| Leukocytes | Blood and lymphatic system disorders | 40 of 64 |
| Neutrophils | Blood and lymphatic system disorders | 33 of 64 |
| Constipation | Gastrointestinal disorders | 30 of 64 |
| Platelets | Blood and lymphatic system disorders | 28 of 64 |
| Anorexia | Gastrointestinal disorders | 28 of 64 |
| Hyponatremia | Metabolism and nutrition disorders | 26 of 64 |
| Hypomagnesemia | Metabolism and nutrition disorders | 21 of 64 |
| Creatinine | Metabolism and nutrition disorders | 19 of 64 |
Serious events with the highest arm-level rate: low neutrophils (57.8%), low leukocytes (29.7%), low platelets (14.1%), fatigue (12.5%), hyponatremia (10.9%).
The adverse-event summary lists 64 participants at risk for serious adverse events, with 49 affected. For other adverse events, it lists 64 at risk and 63 affected. These counts refer to the registry’s safety summary and its stated treated population; they are not the primary efficacy result. The registry record does not report a death count in this adverse-event summary.
The listed top serious adverse-event terms and percentages are Low Neutrophils, 57.8%; Low Leukocytes, 29.7%; Low Platelets, 14.1%; Fatigue, 12.5%; Hyponatremia, 10.9%; and Hypertension, 7.8%. These are the terms and percentages recorded in the safety results. The registry record does not provide additional detail about event severity grading, timing, duration, or whether a participant experienced more than one listed term.
As a general statistical explanation, adverse-event summaries describe events observed in the studied group and do not by themselves establish that the treatment caused each event. In a single-group study, the posted figures also do not provide a randomized safety comparison with another regimen. The affected counts and listed percentages should therefore be read as descriptive safety information, not as comparative estimates.
12. What the Result Does, and Does Not, Mean
This trial addresses a specific population: patients with previously untreated extensive-stage small cell lung cancer. It evaluates a combination of cisplatin, etoposide, and bevacizumab in a phase II, single-group design. Its primary question concerns the percentage alive and progression-free at 6 months, using the registry’s stated definition of progression-free survival.
The registry record does not report the numerical primary endpoint result or its 95% confidence interval. Accordingly, it is not possible to describe the observed percentage or how precisely it was estimated from the posted information. Overall survival and best objective response are named as secondary outcomes, but their numerical results are also not reported in the registry record.
Even if a numerical within-group result were available, a single-group study would not provide a randomized comparison against another treatment. As a general statistical point, outcomes in one group cannot by themselves show what would have happened to the same population under a different treatment. The registry design therefore supports describing the study and its observed outcomes, where reported, rather than making a direct comparative estimate.
The safety summary supplies descriptive counts and selected serious adverse-event percentages. These figures are useful for understanding what the registry recorded among treated participants, but they do not constitute a comparison of safety between treatments. The registry record also does not provide the detail needed to evaluate every aspect of event timing, severity, or attribution.
In short, the record documents the trial question, design, endpoint definition, analysis populations, and selected safety results. It does not report the primary efficacy estimate, confidence limits, or secondary-outcome results. Those gaps limit the conclusions that can be drawn from the registry record; they should not be filled by assumptions about the trial’s findings.
13. Why This Trial Matters Statistically
Statistically, this study illustrates the distinction between describing an outcome and estimating a treatment contrast. The registry records a single-group phase II design, so the study question is framed around outcome within the treated group. There is no randomized comparator in the design to support a direct between-group estimate.
The primary endpoint is defined at a fixed follow-up time and uses a time-to-event definition that includes progression or death without progression. Clear event and time-origin definitions are important because they determine what the measure represents. Here, the registry identifies registration as the time origin and states how participants alive without progression at 6 months contributed to the rate.
It also matters that the registry record does not report the numerical primary estimate or its 95% confidence interval. Statistical interpretation depends not only on an endpoint definition, but also on the estimate and its uncertainty. Without those values, neither the observed level of the endpoint nor its precision can be assessed from the record.
The record distinguishes the per-protocol primary population from the treated safety population. Keeping analysis populations explicit helps readers understand which participants contribute to each type of result. It also highlights why participant flow and missing-data methods matter: the record lists enrollment and analysis counts, but does not give a complete accounting or detailed methods for incomplete outcome data.
Finally, selected adverse-event counts and percentages are descriptive. In a single-group trial, they do not provide comparative safety estimates. Taken together, these features show why design, endpoint definition, analysis population, uncertainty, and reporting completeness all shape what can be concluded from a clinical-trial record.
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 main limitation for statistical interpretation is that the registry record does not report the primary endpoint estimate or its 95% confidence interval. The primary endpoint can be defined, but its observed value and precision cannot be assessed. The numerical results for the listed secondary outcomes—overall survival and best objective response—are also not reported in the registry record.
The study is single-group, with allocation not applicable and no masking. It therefore does not include a randomized concurrent comparator for estimating differences between treatments. The record supports a description of the study design, but not a direct randomized treatment contrast.
The record gives 65 enrolled participants, 63 eligible, treated participants in the primary analysis, and 64 treated participants in the safety analysis. It does not provide a complete participant disposition explaining the differences among these counts. Detailed methods for missing data, censoring, and analysis of the primary endpoint are not reported in the registry record, limiting assessment of how incomplete follow-up may have been handled.
The registry does not report the detailed statistical plan, multiplicity procedures, interim-analysis plan, or the trial’s sample-size justification. The adverse-event summary gives counts and selected percentages, but does not report a death count there or provide further detail on event timing, duration, severity grading, and attribution. These reporting gaps constrain interpretation of both efficacy and safety information. They do not establish that particular methods were omitted from the trial; they mean those methods are not described in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer — NCT00079040.
- Registry record last updated 2014-05-14; status last verified 2012-12.
- Results first posted 2010-02-02.
- 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
NCT00079040 is a completed phase II, single-group study sponsored by the National Cancer Institute (NCI). It evaluated cisplatin, etoposide, and bevacizumab in previously untreated extensive-stage small cell lung cancer. Enrollment was 65; the recorded start was 2006-01 and primary completion was 2009-01.
The primary endpoint was the percentage of participants alive and progression-free at 6 months. The primary analysis included eligible, treated patients (n=63), and the safety analysis included all treated patients (n=64). Overall survival and best objective response are listed as secondary outcomes.
The registry record does not report the primary endpoint estimate or confidence interval, or numerical results for the secondary outcomes. It lists descriptive safety counts and selected serious adverse-event terms and percentages. The single-group design and missing outcome estimates limit comparative interpretation.