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 Cetuximab Plus Conformal Thoracic Radiotherapy in Patients (Pts) With Inoperable or Unresectable Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC) (NCT00673738), a na phase 2 study. The primary outcome is Median Progression Free Survival (PFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00673738 |
| Phase | Phase 2 |
| Condition | Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 27 |
| Arms in the primary outcome | n/a |
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Results posted | Yes |
2. Clinical Question
The study asked whether concurrent cetuximab and conformal thoracic radiotherapy, followed by consolidation docetaxel and cetuximab, could be given to patients with inoperable or unresectable locally advanced non-small cell lung cancer, and what progression-free survival and safety outcomes would be observed. This is a question about outcomes in a treated group, not a direct comparison between treatment strategies.
Population
Patients with inoperable or unresectable, locally advanced non-small cell lung cancer. The registry lists 27 enrolled participants and identifies the primary-endpoint population as all participants.
Intervention
Concurrent cetuximab and conformal thoracic radiotherapy, followed by consolidation docetaxel plus cetuximab. The arm description specifies definitive radiotherapy of 70 Gy in 35 fractions and 3 cycles of consolidation treatment.
Comparator
There was no separate comparison group in this single-group study. The allocation is listed as NA, so outcomes cannot be read as a randomized, like-for-like comparison with another treatment.
Primary question
What was the median progression-free survival, measured from first cetuximab administration to objective disease progression using RECIST criteria? The registry names the endpoint and its timeframe as up to 36 months, but the median and confidence interval are not reported in the registry record.
The registry also lists median overall survival and overall response rate as secondary outcomes. Their outcome results are not reported in the registry record. The study description frames the research around tumor response and treatment-related side effects, but the posted results do not establish whether the regimen performed better or worse than another approach.
3. Trial Design
This was a completed phase II, single-group study sponsored by H. Lee Moffitt Cancer Center and Research Institute. The registry lists enrollment of 27 participants, allocation as NA, and masking as none. The study started in 2008-04 and had a primary completion date of 2013-12. No separate control arm or randomized treatment assignment is described.
The treatment arm was named Cetuximab Plus Radiotherapy. Participants received concurrent cetuximab and conformal thoracic radiotherapy. The arm description specifies definitive radiotherapy of 70 Gy in 35 fractions, described as the institution’s existing standard, followed by 3 cycles of consolidation docetaxel plus cetuximab. The intervention list identifies cetuximab as a drug and conformal thoracic radiotherapy as radiation. Other treatment scheduling details are not reported in the registry record.
The primary endpoint was median progression-free survival, with a stated timeframe of up to 36 months. The endpoint population is listed as all participants. Secondary outcomes were median overall survival and overall response rate. Although three outcome measures are listed, the registry record does not report outcome estimates for these measures or a statistical analysis result.
A single-group design describes outcomes among participants receiving the regimen, but it does not estimate a treatment contrast against a concurrent control. Without such a comparison, differences between observed outcomes and outcomes under another treatment cannot be attributed to the regimen using this design alone. The registry record does not report a detailed protocol, a sample-size justification, or further design details. The listed sample-size illustrations are not the study’s own design assumptions and should not be interpreted as evidence that the trial was planned to achieve a particular power.
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 | Cetuximab Plus Radiotherapy |
|---|---|
| STARTED | 27 |
| COMPLETED | 27 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: All participants
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 | Cetuximab Plus Radiotherapy |
|---|---|---|
| Participants analysed | 27 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 |
| Age, Categorical: >=65 years | Participants | 25 |
| Age, Continuous | years | 72 (58 to 83) |
| Sex: Female, Male: Female | Participants | 9 |
| Sex: Female, Male: Male | Participants | 18 |
| Region of Enrollment: United States | participants | 27 |
6. Primary Endpoint
The registry lists the primary outcome as Median Progression Free Survival (PFS), measured over Up to 36 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is median progression-free survival, expressed in months. The registry defines progression-free survival as the interval from the date of the first cetuximab administration to the date of objective disease progression. Progression was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST). The record describes progressive disease as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
General statistical explanation: a time-to-event endpoint records how long it takes for a defined event to occur. A median summarizes the point in the event-time distribution at which half of the observed population has experienced the event, subject to the study’s event and follow-up definitions. It can describe the timing of progression in a treated group, while a confidence interval conveys uncertainty around the estimated median.
Progression-free survival is often used to summarize disease-control timing without relying only on whether progression occurred by a single assessment point. Its interpretation depends on how progression is assessed, how participants who have no recorded progression are handled, and how follow-up is managed. The registry record does not report the assessment schedule, censoring rules, or the method used to calculate the confidence interval. It also does not state whether death was included as an event in this endpoint definition. The median and 95% confidence interval are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies median progression-free survival as the primary endpoint but does not report a median estimate or its 95% confidence interval. As a result, the posted results do not give a numerical summary of how long participants remained progression-free, nor do they show the precision of such an estimate. The stated endpoint timeframe is up to 36 months; that timeframe alone is not an outcome result.
Median overall survival and overall response rate are listed as secondary outcomes. Their results are not reported in the registry record either. No hazard ratio, comparative effect estimate, p-value, or analysis result is listed. The record lists no analyses. Therefore, the available information does not support a statistical conclusion about the size or uncertainty of an effect on progression-free survival, overall survival, or response rate.
This study has a single treatment group, with allocation listed as NA and no masking. Its results, if reported, would describe outcomes among participants receiving concurrent cetuximab and radiotherapy followed by consolidation docetaxel and cetuximab. They would not by themselves quantify what would have happened under a different treatment. A comparison across separate studies would also not provide the same protection against differences in participant characteristics, follow-up, or outcome assessment that a concurrent randomized comparison can offer.
The safety record reports 20 participants at risk and affected for serious adverse events, with 27 at risk and affected for other adverse events. The serious-event terms listed include dyspnea (shortness of breath) at 18.5%, febrile neutropenia at 14.8%, infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) at 14.8%, pneumonitis/pulmonary infiltrates at 14.8%, dehydration at 11.1%, and dysphagia (difficulty swallowing) at 11.1%. These figures describe recorded safety events in the treatment group; they do not establish that the treatment caused each event. The deaths entry is not reported in the registry record.
The study description indicates that investigators were interested in tumor response and adverse effects, but the registry’s stated aims should not be mistaken for findings. With the efficacy outcomes absent, the main statistical reading is that the record identifies what was intended to be measured, but does not provide the estimates needed to assess those outcomes or their precision.
9. Statistical Methods Explained
The registry record contains a treatment description and endpoint definitions, but no reported analysis estimates. The methods below explain how the listed statistical measures are generally interpreted; they do not fill in details missing from the record.
What does a median time-to-event result mean?
General statistical explanation: a time-to-event analysis follows participants from a defined starting point until a specified event occurs, or until the available follow-up ends without that event being recorded. For this trial, the specified start is first cetuximab administration, and the described event is objective progression. A median time-to-event estimate summarizes the event-time distribution rather than an average duration. It is useful when follow-up times differ or when some participants have not experienced the event by the time observation ends.
Participants without a recorded event by the end of their observation may contribute information up to that point, depending on the analysis method. This is commonly handled through censoring. Censoring rules matter because they define how incomplete event histories enter the analysis. The registry record does not report its censoring rules, how participants lost to follow-up were handled, or how progression assessments were scheduled. Those omissions limit reproducibility and make it difficult to evaluate how the observed follow-up would affect a time-to-event estimate.
What does a confidence interval add?
General statistical explanation: a confidence interval expresses statistical uncertainty around an estimate. A narrower interval indicates greater precision under the method’s assumptions, while a wider interval indicates less precision. The registry specifies a 95% confidence interval as the dispersion measure for median progression-free survival, but neither the interval nor the median is reported in the registry record. Without both, it is not possible to describe the location or precision of the intended primary result.
A confidence interval is not a guarantee that a particular value is correct, and it does not resolve design limitations. In a single-group study, an interval around the group’s median can quantify uncertainty about that group’s outcome under the analysis assumptions. It does not create a treatment comparison or remove the possibility that participant characteristics, subsequent care, or other influences affected the observed outcomes.
What can a single-group design estimate?
General statistical explanation: a single-group study can describe the outcomes observed among participants who received its treatment. A comparative treatment effect requires a contrast between outcomes under different treatment conditions. When a study has no concurrent comparison group, the counterfactual outcome—what these same participants would have experienced under another treatment—is not observed. Consequently, a group’s event-time estimate cannot alone establish that the treatment changed progression timing.
The registry lists allocation as NA, masking as none, and a single-group model. It does not describe randomized assignment or a control arm. Any interpretation should therefore stay with the observed treatment group, rather than imply comparative efficacy. The endpoint population is listed as all participants, but further details about analysis populations are not reported in the registry record.
How should the planning illustrations be read?
General statistical explanation: a sample-size calculation is a planning exercise based on assumptions about the effect to be detected, the statistical testing framework, and the way participants are assigned. The record describes its illustrations as calculations from the observed effect, not as the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For time-to-event illustrations, the quantity is total events using the Schoenfeld approach; other illustrations are expressed as participants per arm.
Those assumptions do not describe the actual single-group treatment design. Equal allocation between two arms is a hypothetical planning framework here, not a feature of the trial. The illustrations should not be described as observed power, and they cannot show that the study had a particular probability of detecting an effect. The registry record does not report a trial-specific sample-size justification. Nor does the information available report the observed effect or numerical planning outputs, so no such values can be interpreted in this account.
What does the safety summary measure?
General statistical explanation: adverse-event summaries count events or participants according to the reporting definitions used in the record. A participant may experience more than one event, and a term-specific percentage may not be interchangeable with the percentage of participants who experienced any event. Serious adverse events and other adverse events are separate summary groupings in the registry. Their reported totals and term frequencies should be read as safety descriptions, not as randomized comparisons or proof of causation.
The registry identifies the treatment group and the numbers at risk and affected for the serious and other adverse-event groupings. It does not report the statistical method for safety comparisons, and the design has no comparator group. The deaths entry is not reported in the registry record. Consequently, the safety information can describe reported events in the study group, but it cannot establish how event frequencies compare with another treatment or background risk.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists median progression-free survival as the primary outcome, with median overall survival and overall response rate as secondary outcomes. It does not report a multiplicity adjustment, a testing hierarchy, or a detailed statistical analysis plan. Because the analysis record contains no reported analyses, there is no stated set of outcome-specific estimates or tests from which to judge how multiple outcomes were handled. Whether any outcomes were analyzed under a prespecified procedure is not reported in the registry record.
Missing-data handling is also not reported in the registry record. For a time-to-event endpoint, important details include how participants without documented progression were treated, how withdrawals and incomplete follow-up were handled, and whether outcome assessments were available for all participants. The registry gives the primary-endpoint population as all participants and states a timeframe of up to 36 months, but does not describe the analysis population beyond that listing or explain how endpoint data availability affected inclusion.
The record does not report the frequency or reasons for missing outcome measurements, a method for addressing missing data, or sensitivity analyses. These details matter because missingness can affect estimates when participants with incomplete records differ systematically from those with complete follow-up. Without the relevant reporting, the degree to which missing observations could influence the endpoint estimates cannot be assessed. No assumptions about analysis populations or missing-data methods should be inferred from the all-participants label alone.
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 |
|---|---|---|---|
| Cetuximab Plus Radiotherapy | 20 | 27 | 74.1% |
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 |
|---|---|
| Cetuximab Plus Radiotherapy | 27 of 27 |
Most frequent serious adverse event terms
| Event term | Organ system | Cetuximab Plus Radiotherapy |
|---|---|---|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | 5 of 27 |
| Febrile neutropenia | Infections and infestations | 4 of 27 |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) | Infections and infestations | 4 of 27 |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | 4 of 27 |
| Dehydration | Gastrointestinal disorders | 3 of 27 |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | 3 of 27 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 3 of 27 |
| Thrombosis/thrombus/embolism | Vascular disorders | 3 of 27 |
| Low Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | 2 of 27 |
| Hypotension | Cardiac disorders | 2 of 27 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cetuximab Plus Radiotherapy |
|---|---|---|
| Fatigue (asthenia, lethargy, malaise) | General disorders | 22 of 27 |
| Rash: dermatitis associated with radiation - Radiation | Skin and subcutaneous tissue disorders | 20 of 27 |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | 19 of 27 |
| Esophagitis | Gastrointestinal disorders | 19 of 27 |
| Pruritus/itching | Skin and subcutaneous tissue disorders | 19 of 27 |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | 18 of 27 |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | 17 of 27 |
| Constipation | Gastrointestinal disorders | 15 of 27 |
| Nausea | Gastrointestinal disorders | 14 of 27 |
| Cough | Respiratory, thoracic and mediastinal disorders | 14 of 27 |
Serious events with the highest arm-level rate: dyspnea (shortness of breath) (18.5%), febrile neutropenia (14.8%), infection with normal anc or grade 1 or 2 neutrophils - lung (pneumonia) (14.8%), pneumonitis/pulmonary infiltrates (14.8%), dehydration (11.1%).
The registry lists 27 participants at risk for other adverse events and 27 affected. For serious adverse events, it lists 27 at risk and 20 affected. These are group-level counts; they do not describe the number of distinct event episodes or establish that an event was caused by treatment. The deaths entry is not reported in the registry record, which should not be read as confirmation that no deaths occurred.
The serious adverse-event terms with the largest listed percentages are dyspnea (shortness of breath), 18.5%; febrile neutropenia, 14.8%; infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia), 14.8%; pneumonitis/pulmonary infiltrates, 14.8%; dehydration, 11.1%; and dysphagia (difficulty swallowing), 11.1%. These are the percentages recorded for the listed terms. The registry excerpt does not specify the term-level denominators or clarify whether participants could be counted under multiple terms.
General statistical explanation: an adverse-event frequency describes what was recorded in the observed group. Without a comparison group, it cannot show whether a frequency is higher or lower than it would have been under another treatment. The listed events are useful for describing reported safety experience, but their interpretation is limited by the absent comparative data and the lack of further event-level details in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed phase II study of concurrent cetuximab and conformal thoracic radiotherapy followed by consolidation docetaxel and cetuximab in patients with locally advanced non-small cell lung cancer. It specifies a primary progression-free survival endpoint and describes how progression was defined. It also reports aggregate adverse-event counts and selected serious-event terms.
What the posted results do not provide is the primary endpoint estimate or its 95% confidence interval. The secondary outcomes of median overall survival and overall response rate are named, but their results are not reported in the registry record. No hazard ratio, p-value, or analysis estimate is available in the record. Thus, the stated aims and endpoint definitions cannot be treated as evidence of the observed efficacy outcomes.
Because the study is single-group, the design describes outcomes in participants receiving the regimen rather than a contrast with another treatment. Even a reported median would describe the treated group’s progression experience; it would not on its own establish what caused that experience or how it compares with an alternative. No treatment recommendation or conclusion about benefit can be drawn from the information reported.
The safety entries indicate that adverse events were recorded among participants, including serious events and the listed term-specific percentages. They do not establish causation or comparative safety. Additional information about event definitions, timing, attribution, missing follow-up, and deaths is not reported in the registry record. Overall, the record gives important context about the treatment and planned outcomes, but the missing efficacy estimates and limited design details constrain statistical interpretation.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a stated research question and a reported result. The record names progression-free survival as the primary endpoint, defines progression using RECIST criteria, and specifies a measurement window of up to 36 months. Those details identify what the investigators intended to assess. They do not replace the outcome estimate, its uncertainty, or an account of how incomplete follow-up was handled.
The single-group design also makes the target of inference important. A treatment group’s observed outcomes can be described, but there is no concurrent control group to estimate a treatment contrast. That distinction matters whenever readers are asked to interpret survival or response outcomes: descriptive experience and comparative effect are different statistical quantities.
The record also highlights why safety counts should be interpreted separately from efficacy findings. It reports group-level numbers affected and percentages for selected serious-event terms, but does not report a comparison or establish causation. Counts describe recorded events, while comparative safety requires an appropriate basis for comparison.
Finally, planning illustrations should be kept distinct from the actual study design. The stated calculation assumptions include equal allocation between two arms, whereas this study is listed as single-group. Those illustrations are explicitly not the trial’s own design and do not constitute observed power. Careful separation of design, endpoint definition, observed result, and planning calculation is central to sound interpretation of clinical research.
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 consequential limitation for statistical interpretation is that the registry record does not report the primary progression-free survival estimate or its 95% confidence interval. The secondary outcome results are also not reported. Without those results, the intended efficacy outcomes cannot be quantitatively assessed from this record.
The design is single-group, with allocation listed as NA and masking as none. There is no concurrent control group for a treatment contrast. The record therefore supports description of the treatment group, not a causal comparison with another treatment. Participant eligibility criteria and detailed baseline characteristics are not reported in the registry record, limiting assessment of the population represented by the enrolled group.
Details needed to evaluate the time-to-event analysis are also absent. The registry does not report the progression assessment schedule, censoring rules, handling of incomplete follow-up, or the method used to calculate the confidence interval. The record names all participants as the primary-endpoint population, but further analysis-population details and missing-data methods are not reported. It does not provide the trial-specific sample-size justification or a detailed statistical analysis plan.
Safety information is limited to aggregate counts and selected serious-event terms. The deaths entry is not reported in the registry record, and the record does not provide further details about event attribution or the term-level denominators. These limitations do not negate the reported descriptions, but they restrict how precisely the efficacy and safety experience can be characterized.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cetuximab Plus Conformal Thoracic Radiotherapy in Patients (Pts) With Inoperable or Unresectable Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC) — NCT00673738.
- Registry record last updated 2015-10-08; status last verified 2015-09.
- Results first posted 2014-03-04.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed phase II, single-group study sponsored by H. Lee Moffitt Cancer Center and Research Institute, with 27 participants enrolled. Treatment consisted of concurrent cetuximab and conformal thoracic radiotherapy, followed by consolidation docetaxel plus cetuximab. The arm description specifies radiotherapy of 70 Gy in 35 fractions and 3 cycles of consolidation treatment.
Median progression-free survival was the primary endpoint, defined from first cetuximab administration to objective progression under RECIST criteria, with a timeframe of up to 36 months. Median overall survival and overall response rate were secondary outcomes. The outcome estimates are not reported in the registry record. Aggregate adverse-event counts and selected serious-event percentages are listed, but no comparator group is described, and deaths are not reported in the registry record.