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 Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer (NCT00402883), a na phase 2 study. The primary outcome is Time to Progression.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00402883 |
| Phase | Phase 2 |
| Condition | Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 5 |
| Arms in the primary outcome | n/a |
| Lead sponsor | SCRI Development Innovations, LLC |
| Results posted | Yes |
2. Clinical Question
Population
People with unresectable stage III non-small-cell lung cancer. The registry lists Lung Cancer as the condition and describes the study population as patients with unresectable stage III non-small-cell lung cancer.
Intervention
A regimen combining carboplatin, pemetrexed, radiotherapy and bevacizumab, with folic acid and vitamin B12 also listed among the interventions. The arm description states that induction treatment included carboplatin AUC=5, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg, administered intravenously in weeks 1 and 4. Concurrent radiation was described as 1.8 Gy/d in weeks 1 to 7, to a total of 61.2 Gy per institutional guidelines. The remaining consolidative-therapy description is incomplete in the registry record.
Comparator
There was no separate comparison group: the study is recorded as single group, with allocation listed as NA. The study therefore does not provide a randomized, like-for-like treatment comparison.
Primary question
The primary outcome was time to progression, with an 18-month timeframe. The registry says no patients were analyzed because the study ended early following the formation of tracheoesophageal fistulas. It consequently provides no estimate of time to progression for the studied regimen and no comparison with another treatment.
3. Trial Design
This was a Phase II, single-group study of a combination of chemotherapy, radiotherapy and bevacizumab in people with unresectable stage III non-small-cell lung cancer. The registry records no allocation method and no masking. Enrollment was 5. The study began in 2006-11, and primary completion was recorded as 2009-01. Its status is terminated.
The intervention description identifies induction treatment with carboplatin AUC=5, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg, administered intravenously in weeks 1 and 4. Radiation was administered concurrently at 1.8 Gy/d in weeks 1 to 7, to a total of 61.2 Gy per institutional guidelines. The record also lists folic acid and vitamin B12. It begins to describe consolidative therapy but the description is incomplete; further details are not reported in the registry record.
The study was not designed as a randomized comparison in the record: it is identified as single group, and allocation is NA. There is therefore no control-arm outcome against which to compare the intervention. The registry identifies Objective Response Rate and Overall Survival as secondary outcomes, alongside the primary outcome of Time to Progression. It reports no analyzed patients for the primary outcome, and no analyses are listed. The registry does not report the trial's statistical analysis plan or the reasons for selecting the enrollment target of 5.
The registry's brief summary describes the study purpose as examining whether the combination expands treatment options. That stated purpose is not itself evidence of an outcome. Because the study ended early and no patients were analyzed for the primary endpoint, the design and record do not yield an estimate of the intervention's effect on time to progression.
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.
Induction Therapy
| Stage | Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab |
|---|---|
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
Consolidation Therapy
| Stage | Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab |
|---|---|
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
Maintenance Therapy
| Stage | Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab |
|---|---|
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: No patients were analyzed due to the fact that the study ended early because of the formation of tracheoesophageal fistulas.
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 | Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab |
|---|---|---|
| Participants analysed | 5 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 |
| Age, Categorical: >=65 years | Participants | 2 |
| Age, Continuous | years | 64.6 (SD 8.9) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 3 |
| Region of Enrollment: United States | participants | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Progression, measured over 18 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
Time to progression is the stated primary endpoint, with an 18-month timeframe. In general, this endpoint concerns the time from a defined starting point until documented disease progression. It is used in clinical research to describe how long participants remain without progression under the study's endpoint definition. The specific starting point, progression criteria, assessment schedule and handling of deaths are not reported in the registry record, so the exact operational definition cannot be reconstructed from this record.
For a time-to-event endpoint, a participant's information may be incomplete at the end of observation if progression has not been recorded or follow-up ends for another reason. General methods can account for such observations through censoring, but the registry record does not report the censoring rules or any analysis method for this endpoint. Those details matter because estimates depend on how event times and incomplete follow-up are defined and handled.
Most importantly, the registry states that no patients were analyzed for time to progression because the study ended early following formation of tracheoesophageal fistulas. No endpoint estimate, confidence interval or test result is reported. Thus the endpoint's intended clinical meaning can be described, but its observed distribution in this study cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies time to progression as the primary outcome and gives an 18-month timeframe. It does not report an analyzed endpoint result: the outcome population is described as having no patients analyzed because the study ended early following formation of tracheoesophageal fistulas. Accordingly, there is no time-to-progression estimate or precision measure to interpret. The record cannot establish the pattern of progression times among participants.
The study enrolled 5 people and was recorded as terminated. Enrollment is not the same as an analysis population. In this record, the stated absence of patients analyzed for the primary endpoint means that enrollment should not be read as evidence that five outcome observations were available or used. The registry does not provide a participant flow account explaining follow-up or outcome availability beyond its statement about early termination.
The record lists Objective Response Rate and Overall Survival as secondary outcomes, but it gives no results for them. It also lists 3 outcome measures and 0 analyses. These entries do not supply evidence of an observed response rate, survival estimate or treatment comparison. The registry does not report an inferential result for any of those outcomes.
For adverse events, the record reports 5 participants at risk and 5 affected in the serious adverse-event group, and 5 at risk and 5 affected in the other adverse-event group. The serious terms listed include Shortness of Breath, Pneumonia, Transesophageal fistula, Chest Pain, Hemoptysis and Difficulty swallowing, with the corresponding percentages stated in the safety reading. These are registry safety entries, not evidence by themselves that the intervention caused any event. The registry's statement about early termination following formation of tracheoesophageal fistulas provides context for the decision to end the study, but it does not give a causal estimate.
The absence of endpoint analysis is not a null result. It does not show that progression was absent, delayed or unchanged; rather, the record contains no analyzed data from which to answer the primary question. Likewise, a small enrollment and the termination status do not permit a precise estimate of the intervention's effect. A single-group study would not in any case provide a randomized contrast against usual care or another regimen.
Any sample-size illustrations based on an observed endpoint effect require an effect estimate to serve as their starting point. Because the primary outcome has no analyzed patients in this record, the study's endpoint results cannot support such an estimate. Illustrative planning values, if displayed, should not be interpreted as observed power or as evidence that the trial detected an effect.
9. Statistical Methods Explained
What does a single-group design permit?
The registry classifies the study as single group, with allocation recorded as NA and masking recorded as none. General statistical context: a single-group study can describe outcomes among participants who receive the intervention, if those outcomes are collected and analyzed. Without a separate control group, it does not estimate a randomized between-group treatment contrast. Outcomes can also reflect factors other than the intervention, so a before-and-after observation is not equivalent to a controlled comparison.
Here, the primary outcome is reported as having no analyzed patients. That means there is no observed time-to-progression estimate to describe, even as a single-group result. Enrollment was 5, but enrollment alone does not establish how many participants had outcome data or how many could be included in an analysis. The registry does not report an analysis population for the primary endpoint.
How would time-to-event analysis work in general?
General statistical context: time-to-event methods describe the time until a specified event, such as progression. They can use information from participants who have not had an event by their last observed follow-up, rather than treating those participants as if their event time were known. Such observations are commonly handled as censored. An estimate may be displayed as a survival curve, where the event-free proportion changes over follow-up, or as a summary of event timing. A confidence interval expresses uncertainty around an estimate; wider intervals indicate less precision, while narrower intervals indicate greater precision, under the method's assumptions.
These methods rely on a clearly defined event, time origin, follow-up process and censoring approach. For this study, the registry does not report the specific progression criteria, time origin, assessment schedule, censoring rules, or estimator used. It also reports no analyzed patients for the endpoint. Therefore, general descriptions of time-to-event methods explain what could be used in principle, not what was used or estimated in this study.
What does the absence of a reported analysis mean?
The registry reports 0 analyses and says no patients were analyzed for the primary outcome because the study ended early following the formation of tracheoesophageal fistulas. This is different from a completed analysis that finds no statistically significant effect. A non-significant result would still require analyzed observations and a reported estimate or test. Here, the record provides no such primary-outcome result.
General statistical context: when an analysis is available, an effect estimate and its confidence interval are often more informative than a significance test alone. The estimate describes the observed direction and magnitude, while the interval communicates precision under the chosen method. Neither can be assessed for time to progression from this record. The record also does not report a hazard ratio, median time to progression, event count, p-value or confidence interval for the primary endpoint.
How should planning calculations be understood?
The planning illustration assumptions described in the record use a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation; the effect to detect is described as a stated fraction of an observed effect. The record says time-to-event illustrations use a total number of events, while other illustrations use participants per arm. These are planning assumptions, not descriptions of the actual study design. The actual study is single group, not an equal-allocation two-arm comparison.
The record contains no analyzed primary endpoint data and therefore no observed time-to-progression effect on which to base a planning illustration. If an illustration is displayed using an effect drawn from posted results, it cannot be treated as a result of this study's primary endpoint. General statistical context: sample-size calculations estimate how much information a future design might need under chosen assumptions. They do not measure the probability that a completed study's finding is true, and they are not observed power. Their interpretation depends on the assumed effect, variability or event process, analysis method and design.
The registry does not report the protocol's sample-size justification, planned statistical analysis, interim analyses, adjustment strategy or stopping rules. The reason enrollment was 5 is not stated. The record's description that the study ended early following formation of tracheoesophageal fistulas is not enough to reconstruct a formal monitoring or stopping procedure.
Why does over-dispersion matter in general?
General statistical context: count outcomes can vary more than a simple probability model expects. This extra variability is called over-dispersion. If it is ignored, standard errors may be too small and confidence intervals too narrow, making results appear more precise than the data justify. Models that allow extra variability can address that issue when appropriate. The registry does not report a count-based primary endpoint or an analysis involving over-dispersion, so this concept does not describe a reported method for this trial.
Overall, the statistical methods that were actually used for the primary endpoint are not reported in the registry record. The lack of an analyzed endpoint is the central limitation for statistical interpretation: no effect estimate, uncertainty interval or inferential test is available.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies Time to Progression as the primary outcome and lists Objective Response Rate and Overall Survival as secondary outcomes. It also reports 3 outcome measures and 0 analyses. No outcome analysis results or statistical testing details are reported. In particular, the registry does not report whether the investigators planned an adjustment for testing multiple outcomes, how any secondary outcomes were to be analyzed, or which analysis would be considered primary if multiple measures were examined.
General statistical context: when several outcomes or multiple analyses are tested, the chance of a false-positive finding can increase if each test is interpreted independently. A prespecified testing order or multiplicity adjustment can help control that risk. Without a reported analysis plan and results, it is not possible to assess whether multiplicity was addressed in this study. Since no primary endpoint patients were analyzed, the record does not present a set of efficacy tests whose multiplicity can be evaluated.
The record gives no details about missing-data definitions, follow-up completion, censoring, exclusions or analysis populations beyond stating that no patients were analyzed for the primary outcome. That statement should not be converted into an assumption that outcome values were missing at random, that participants were excluded for a particular reason, or that an intention-to-treat analysis was conducted. Those details are not reported in the registry record.
The registry's early-termination statement explains that the study ended early following formation of tracheoesophageal fistulas, but does not describe the statistical handling of participants or outcomes after termination. Nor does it report interim analyses or a prespecified stopping rule. These omissions prevent reconstruction of the intended analysis and the data flow from enrollment to analysis.
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 |
|---|---|---|---|
| Intervention | 5 | 5 | 100.0% |
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 |
|---|---|
| Intervention | 5 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | Intervention |
|---|---|---|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | 2 of 5 |
| Pneumonia | Infections and infestations | 2 of 5 |
| Transesophageal fistula | Gastrointestinal disorders | 2 of 5 |
| Chest Pain | Cardiac disorders | 1 of 5 |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | 1 of 5 |
| Difficulty swallowing | Gastrointestinal disorders | 1 of 5 |
| Dislodged PEG tube | Gastrointestinal disorders | 1 of 5 |
| Esophagitis | Gastrointestinal disorders | 1 of 5 |
| Anemia | Blood and lymphatic system disorders | 1 of 5 |
| Hypokalemia | Metabolism and nutrition disorders | 1 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Intervention |
|---|---|---|
| Anorexia | Gastrointestinal disorders | 5 of 5 |
| Cough | Respiratory, thoracic and mediastinal disorders | 5 of 5 |
| Esophagitis | Gastrointestinal disorders | 5 of 5 |
| Fatigue | General disorders | 5 of 5 |
| Hematologic - ANC | Blood and lymphatic system disorders | 5 of 5 |
| Hematologic - Hemoglobin | Blood and lymphatic system disorders | 5 of 5 |
| Hematologic - Platelets | Blood and lymphatic system disorders | 5 of 5 |
| Hematologic - WBC | Blood and lymphatic system disorders | 5 of 5 |
| Nausea | Gastrointestinal disorders | 5 of 5 |
| Dysphagia | Respiratory, thoracic and mediastinal disorders | 4 of 5 |
Serious events with the highest arm-level rate: shortness of breath (40.0%), pneumonia (40.0%), transesophageal fistula (40.0%), chest pain (20.0%), hemoptysis (20.0%).
The registry lists 5 participants at risk and 5 affected for serious adverse events. It also lists 5 participants at risk and 5 affected for other adverse events. These entries describe the recorded safety-group totals; they should not be interpreted as a detailed account of event timing, recurrence, severity grades or attribution. Those details are not reported in the registry record.
The serious adverse-event terms and percentages listed are Shortness of Breath at 40.0%, Pneumonia at 40.0%, Transesophageal fistula at 40.0%, Chest Pain at 20.0%, Hemoptysis at 20.0% and Difficulty swallowing at 20.0%. The record does not give additional event-level information alongside these terms. These percentages describe registry entries and do not establish that the intervention caused the events. The listed term Transesophageal fistula is not identical in wording to the registry's statement that the study ended early following formation of tracheoesophageal fistulas; the record does not explain the relationship between those descriptions.
Safety information should be read in the context of the enrollment of 5 and the early termination. The small recorded group and absence of further details limit how broadly the entries can be interpreted. The registry does not report an exposure-adjusted event rate or a comparison with another group.
12. What the Result Does, and Does Not, Mean
The record documents a Phase II, single-group study of chemotherapy, radiotherapy and bevacizumab in unresectable stage III non-small-cell lung cancer. It records enrollment of 5 and terminated status. It names time to progression as the primary outcome, with an 18-month timeframe, but says no patients were analyzed because the study ended early following formation of tracheoesophageal fistulas. The principal statistical finding is therefore the absence of an analyzed primary endpoint result, not an estimate showing benefit or lack of benefit.
The registry also lists Objective Response Rate and Overall Survival as secondary outcomes, without results. No comparison group is recorded, so the study cannot provide a randomized comparison with another treatment. The record does not report effect estimates, confidence intervals or significance tests for the named outcomes.
These registry entries do not show that the intervention does or does not change progression, response or survival. They also do not establish the cause of the fistulas or of any other adverse event. The safety entries are important descriptions in the registry, but they do not by themselves establish causation. The registry records that early termination followed formation of tracheoesophageal fistulas; it does not supply a causal analysis.
General statistical context: a small study with no analyzed primary endpoint cannot establish a precise outcome pattern. Even when a study has analyzed data, uncertainty depends on the number and quality of observations, the event process and the analysis method. In this record, there is no primary outcome estimate whose precision can be assessed. Enrollment should not be mistaken for an analyzed sample, and an illustrative planning calculation should not be mistaken for evidence that an effect was observed.
The record is most informative about the study's design, enrollment, status, planned outcome labels and the stated reason for ending early. It is not an efficacy result. Any conclusion about treatment effects would go beyond what the posted results report.
13. Why This Trial Matters Statistically
This study matters statistically because it illustrates the distinction between a trial's intended question and the evidence available to answer it. The intended primary question concerned time to progression over an 18-month timeframe. The registry says no patients were analyzed for that endpoint and records early termination. As a result, the primary clinical question remains unanswered by an effect estimate in this record.
It also illustrates why enrollment and analysis counts should be kept separate. The study enrolled 5, but the registry does not report analyzed participants for the primary endpoint. A reader cannot infer outcome availability, event counts or follow-up duration from enrollment alone. A trial's planned outcome and timeframe likewise do not establish that the endpoint was measured and analyzed.
The single-group design is another important statistical feature. Without a control group, the study cannot estimate a randomized treatment contrast, even if an outcome result had been available. Here, no primary endpoint analysis is reported either, so there is no within-group time-to-progression estimate to assess.
Finally, the record distinguishes a stated reason for ending early from a statistical stopping procedure. It reports termination following formation of tracheoesophageal fistulas, but does not report a stopping rule, interim analysis plan or statistical analysis plan. Those details cannot be inferred from the termination status. The statistical value of the record lies in clearly identifying these limits: it documents the design and the absence of primary outcome analysis, rather than supporting a treatment-effect conclusion.
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 that the registry reports no patients analyzed for the primary outcome. No time-to-progression result, event count, estimate of uncertainty or inferential test is available. The primary timeframe is stated as 18 months, but the record does not describe follow-up or how progression was assessed.
Enrollment was 5, and the study is recorded as terminated. The registry does not provide a participant-flow account or explain how many participants began, completed or discontinued the regimen. It also does not describe the analysis population for the secondary outcomes. Although Objective Response Rate and Overall Survival are listed, their results are not reported.
The study has a single-group design and no comparator. Consequently, even a reported outcome would not provide a randomized contrast against another treatment. The absence of masking is recorded, but the registry does not describe outcome-assessment procedures. Details of progression criteria, assessment timing, censoring, missing-data handling and the statistical methods used are not reported in the registry record.
The intervention description includes induction treatment and concurrent radiation details, but the consolidative-therapy description is incomplete. The registry does not report why enrollment was 5, the sample-size justification, interim analyses, multiplicity handling or a stopping rule. It states that the study ended early following formation of tracheoesophageal fistulas, but does not provide a causal analysis of events.
The safety record contains group totals and selected serious-event terms with percentages, but does not give event-level details or a comparison group. These entries cannot establish treatment causality or quantify relative risk. Together, the early termination, lack of primary endpoint analysis and limited design and methods information sharply restrict interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer — NCT00402883.
- Registry record last updated 2021-11-09; status last verified 2021-11.
- Results first posted 2014-01-13.
- 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
This is a Phase II, single-group study of chemotherapy, radiotherapy and bevacizumab for unresectable stage III non-small-cell lung cancer. The registry records enrollment of 5, no masking, terminated status, a start in 2006-11 and primary completion in 2009-01.
Time to Progression, with an 18-month timeframe, is the primary outcome. The registry says no patients were analyzed because the study ended early following formation of tracheoesophageal fistulas. Objective Response Rate and Overall Survival are listed as secondary outcomes, but results are not reported. No analysis results are listed.
The safety record reports 5 participants at risk and 5 affected in both the serious and other adverse-event groups, and lists selected serious-event terms with percentages. No comparator is recorded. Statistical methods, the sample-size justification and further outcome-analysis details are not reported in the registry record. The available record therefore describes the study and its early end, but provides no analyzed primary outcome estimate.