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 Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer (NCT00145418), a na phase 2 study. The primary outcome is Response Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00145418 |
| Phase | Phase 2 |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Oncology Specialists, S.C. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with previously untreated, unresectable stage IV or IIIB non-small cell lung cancer. The registry record lists 15 enrolled participants.
Intervention
Oxaliplatin combined with docetaxel, described as first-line therapy. The registry record identifies a single treatment group.
Comparator
There was no separate comparator group in the recorded design. Allocation is listed as not applicable, and the study model is single group.
Primary question
The primary objective was to determine the response rate by RECIST criteria for the combination in patients with previously untreated non-small cell lung cancer.
The registry describes a phase 2 study of oxaliplatin plus docetaxel for people with unresectable non-small cell lung cancer. Its primary question concerns tumor response during treatment, assessed using RECIST criteria. The record also identifies a safety objective: describing the safety profile of first-line treatment by recording grade 3 and 4 adverse events. Time to progression and duration of response are listed as secondary outcomes.
This design addresses what was observed among participants receiving the combination, rather than whether the combination performed differently from another treatment. Because the study is single group and has no recorded comparator, the response and safety observations cannot, on their own, establish a treatment difference. The registry lists 15 enrolled participants and marks the study as terminated. It does not report the primary response-rate result, so the stated objective cannot be answered from the posted results in this record.
3. Trial Design
The registry record identifies NCT00145418 as a phase 2 study of oxaliplatin and docetaxel for first-line treatment of stage IV or IIIB unresectable non-small cell lung cancer. Oncology Specialists, S.C. is listed as the sponsor. The study began in 2005-02, had a primary completion date of 2009-08, and is marked terminated.
The recorded model is single group, with no masking and allocation listed as not applicable. The sole arm is described as receiving oxaliplatin plus docetaxel. The registry lists 15 participants as enrolled. It does not describe a concurrent control arm or a randomized allocation process. This is therefore a within-group treatment study in the registry, not a like-for-like comparison between treatment groups.
The primary objective was to assess response rate by RECIST criteria in patients with previously untreated non-small cell lung cancer. The registry says response was measured every 2 cycles until disease progression. Secondary outcomes include time to progression, duration of response, and a safety objective focused on recording grade 3 and 4 adverse events.
The record does not report the protocol’s sample-size justification, detailed treatment schedule, participant flow, or reasons for termination. It also does not state whether the study stopped early, or why. Although the registry lists a primary completion date, that date alone does not explain the study’s conduct or the status of outcome collection. No more detailed analysis plan is 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.
Before assignment: patients were screened to see if they met eligibility criteria. If criteria met, enrolled into study. Otherwise listed as screen failures.
Overall Study
| Stage | Oxaliplatin + Docetaxel |
|---|---|
| STARTED | 15 |
| COMPLETED | 15 |
| 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 | Oxaliplatin + Docetaxel |
|---|---|---|
| Participants analysed | 15 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 8 |
| Age, Categorical: >=65 years | Participants | 7 |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 10 |
| Region of Enrollment: United States | participants | 15 |
6. Primary Endpoint
The registry lists the primary outcome as Response Rate, measured over Response is measured every 2 cycles until disease progression.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is response rate by RECIST criteria among patients with previously untreated non-small cell lung cancer. The registry defines complete response as disappearance of all disease and partial response as at least a 30% decrease in the sum of the longest dimensions of target lesions. Progressive disease is defined in the record as at least a 20% increase in that sum; stable disease is neither sufficient shrinkage for partial response nor sufficient increase for progressive disease. The record labels the outcome as a number of participants and says response is measured every 2 cycles until disease progression.
In general, a response endpoint provides a categorical way to describe tumor change during treatment. The RECIST categories distinguish disappearance, sufficient shrinkage, sufficient growth, and neither qualifying shrinkage nor growth. A response rate ordinarily summarizes the proportion meeting the response definition, but the registry’s primary outcome result is not reported in the registry record. No response count or response-rate estimate is available in the posted results described by this record.
Response is used because it directly matches the stated phase 2 objective: assessing tumor response to the combination. It is not interchangeable with the listed secondary outcomes of time to progression or duration of response. Those outcomes address timing, and their results are also not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record specifies a clinically framed objective but does not report its primary result. It names response rate by RECIST criteria as the primary outcome and describes the assessment schedule as every 2 cycles until disease progression. However, no number of participants with complete response, partial response, stable disease, or progressive disease is reported. There is also no response-rate estimate or confidence interval. Consequently, the posted record does not establish the observed response experience in this group or the precision of any estimate.
The study enrolled 15 participants and used a single-group design. That means the study could describe outcomes among people treated with oxaliplatin plus docetaxel, but its recorded structure does not provide a separate group receiving another treatment for a direct comparison. Even if an outcome count were available, a single-group result would not by itself identify how outcomes would have differed under a comparator treatment. Differences in participant characteristics, disease course, or other factors cannot be separated from treatment effects without an appropriate comparison.
The record lists safety information for the oxaliplatin-plus-docetaxel group. It reports 9 of 15 participants with serious adverse events and 15 of 15 with other adverse events. The listed serious-event terms include dehydration, catheter infection, nausea, clostridium difficile colitis, hemoptysis, and fatigue, each with the percentages recorded in the safety information. These observations describe events recorded in the study group; they do not establish that treatment caused each event. The record does not provide event timing, duration, severity details beyond the stated safety objective, or a comparator safety experience.
The study is marked terminated, but the registry record does not state why. The record also lists no analyses. It does not report results for time to progression, duration of response, or the primary response endpoint. A study’s status and enrollment do not substitute for outcome results, and the absence of a posted result should not be interpreted as evidence of either benefit or lack of benefit.
Overall, the available information supports a description of the intended question, design, enrollment, and recorded safety counts. It does not support a quantitative conclusion about tumor response, a comparison with another regimen, or a complete assessment of uncertainty. No statistical significance test or adjusted estimate is reported in the registry record.
9. Statistical Methods Explained
The registry record identifies a phase 2, single-group study with no masking. It does not report a detailed statistical analysis plan, and no analyses are listed. The methods below explain how the stated endpoint and design are generally interpreted; they should not be read as a description of unreported procedures used in this trial.
What does a response-rate endpoint represent?
In general, response rate is a binary outcome when participants are classified as meeting or not meeting a specified response definition. The clinical definition matters: the registry describes RECIST categories based on changes in target lesions and disappearance of disease. A response-rate estimate requires both a defined set of participants and reported outcome classifications. The registry record does not report the number classified as responders or the response-rate estimate, so neither can be evaluated for this study from the posted results.
The registry’s description includes complete response and partial response, as well as progressive disease and stable disease. These categories distinguish different patterns of tumor change. The record says response is assessed every 2 cycles until disease progression, but does not report how assessments were handled if a participant missed an assessment or stopped treatment before an assessment. That handling is not reported in the registry record.
What would uncertainty around a response estimate mean?
In general, a confidence interval describes a range of values compatible with an estimate under a specified statistical method and assumptions. It conveys uncertainty about the estimate; it does not mean that the true value is known to lie within that range with certainty. For a binary outcome, the interval’s precision depends in part on the number of participants with evaluable outcome data and the observed response count. Neither a confidence interval nor the response data needed to assess one is reported in the registry record.
A small study group can leave substantial uncertainty around a descriptive estimate, even when the estimate itself is reported. Here, the registry lists 15 enrolled participants but does not state how many were included in the primary endpoint analysis or whether all had evaluable response assessments. It would therefore be inappropriate to infer precision from enrollment alone.
What can a single-group design establish?
In general, a single-group study can describe outcomes observed among participants receiving a treatment. It does not create a concurrent treatment contrast. Without a comparator group, outcome differences attributable to treatment cannot be cleanly distinguished from other explanations, such as participant characteristics or the natural course of disease. This is a design limitation for causal comparison, not a defect in the arithmetic used to describe the group.
The registry lists allocation as not applicable and identifies a single group receiving oxaliplatin plus docetaxel. It does not describe a randomized comparison. Accordingly, no between-group treatment effect can be estimated from the design described in the record.
Why does over-dispersion matter in general?
Over-dispersion is a general issue for some count-data models: observed variation can exceed what a simple model assumes. When that happens, standard errors and confidence intervals from the simpler model may be too small, creating an overly precise impression. The primary endpoint in this record is described as a participant count for a response outcome, not as a repeated event count, and no count-model analysis is reported. The registry record does not provide enough analysis detail to determine whether over-dispersion was relevant to any planned or conducted analysis.
What can be inferred from the safety counts?
In general, a participant count with an event is a descriptive summary. Interpretation depends on the event definition, observation period, attribution rules, and whether repeated events in one participant are counted once or more than once. The registry reports participant counts for serious and other adverse events in the treatment group, but does not describe all of those counting rules. The listed percentages for selected serious-event terms should be read as recorded safety information, not as a comparative treatment effect.
The record does not report a statistical test, adjusted analysis, confidence interval, or model for these safety data. No inferential method should be attributed to the study based on the registry entry alone. The same caution applies to the unreported primary and secondary outcomes.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary response-rate outcome and secondary outcomes of time to progression, duration of response, and safety. It does not report a multiplicity strategy, such as whether testing across outcomes was controlled or whether any outcomes were designated exploratory. No analyses are listed. Without a reported analysis plan and results, the record does not show how multiple outcomes, time points, or response categories were handled statistically.
In general, multiplicity arises when several hypotheses or outcomes are examined: the more opportunities there are to identify a seemingly notable result, the more important it is to understand the analysis plan. This general concern does not establish that a particular error occurred in this study. The registry record does not describe interim analyses, outcome hierarchy beyond identifying the primary and secondary outcomes, or any adjustment for multiple testing.
Missing-data handling is also not reported in the registry record. The record does not state how participants without an evaluable response assessment were treated, whether missing assessments occurred, or how withdrawals and treatment discontinuations affected endpoint analyses. It does not report the number included in an analysis population for the primary endpoint or define an intention-to-treat, per-protocol, or other population.
These omissions limit interpretation because the enrolled count alone does not reveal how many participants contributed to each outcome. They also prevent assessment of whether missing observations could have affected the results. Since no primary or secondary outcome analyses are posted, the record cannot clarify how these issues influenced any reported estimate.
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 |
|---|---|---|---|
| Oxaliplatin + Docetaxel | 9 | 15 | 60.0% |
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 |
|---|---|
| Oxaliplatin + Docetaxel | 15 of 15 |
Most frequent serious adverse event terms
| Event term | Organ system | Oxaliplatin + Docetaxel |
|---|---|---|
| Dehydration | Gastrointestinal disorders | 2 of 15 |
| Catheter infection | Infections and infestations | 1 of 15 |
| nausea | Gastrointestinal disorders | 1 of 15 |
| clostridium difficile colitis | Gastrointestinal disorders | 1 of 15 |
| hemoptysis | Respiratory, thoracic and mediastinal disorders | 1 of 15 |
| fatigue | General disorders | 1 of 15 |
| pain | Nervous system disorders | 1 of 15 |
| chest pain | Respiratory, thoracic and mediastinal disorders | 1 of 15 |
| pericardial effusion | Cardiac disorders | 1 of 15 |
| diarrhea | Gastrointestinal disorders | 1 of 15 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Oxaliplatin + Docetaxel |
|---|---|---|
| neuropathy | Nervous system disorders | 12 of 15 |
| anemia | Blood and lymphatic system disorders | 12 of 15 |
| Nausea | Gastrointestinal disorders | 10 of 15 |
| fatigue | General disorders | 7 of 15 |
| Headache | Nervous system disorders | 6 of 15 |
| diarrhea | Gastrointestinal disorders | 6 of 15 |
| neutropenia | Blood and lymphatic system disorders | 6 of 15 |
| dysguesia | Nervous system disorders | 5 of 15 |
| alopecia | Skin and subcutaneous tissue disorders | 5 of 15 |
| thrombocytopenia | Vascular disorders | 5 of 15 |
Serious events with the highest arm-level rate: dehydration (13.3%), catheter infection (6.7%), nausea (6.7%), clostridium difficile colitis (6.7%), hemoptysis (6.7%).
The registry lists 15 participants at risk for serious adverse events and reports 9 participants affected in the oxaliplatin-plus-docetaxel group. For other adverse events, it lists 15 at risk and 15 affected. These are participant counts, not counts of all individual episodes, and the record does not describe whether a participant with repeated events is counted once or multiple times in each summary.
The record lists dehydration at 13.3% among the serious-event terms and catheter infection, nausea, clostridium difficile colitis, hemoptysis, and fatigue at 6.7% each. These are the selected serious-event terms recorded in the registry. They should not be treated as a complete event profile, and the record does not provide a comparator group for evaluating relative frequency.
The safety objective refers to recording grade 3 and 4 adverse events, while the registry also reports serious adverse event counts. Seriousness and grade are distinct classifications in general; the record does not explain their relationship for these particular summaries. It does not provide timing, duration, attribution, or a detailed account of event management. The counts describe reported events among study participants and do not, on their own, establish that the treatment caused them.
12. What the Result Does, and Does Not, Mean
The registry record documents a phase 2 study of oxaliplatin plus docetaxel as first-line therapy for previously untreated, unresectable stage IV or IIIB non-small cell lung cancer. It states that the primary objective was to assess response by RECIST criteria and that the safety objective concerned grade 3 and 4 adverse events. It also records enrollment of 15 participants and selected adverse-event summaries.
Those details do not provide the primary response result. The registry record does not report the response count, response rate, or uncertainty around a response estimate. It also does not report results for time to progression or duration of response. Thus, the stated clinical question about response cannot be resolved using the outcome information in this record.
The single-group design does not compare the combination with another treatment. As a general statistical point, a descriptive outcome in one group cannot by itself determine what would have happened to comparable participants under a different treatment. The record therefore does not establish a comparative effect, regardless of how the study’s unreported outcome results might have appeared.
The safety counts describe participants with reported events, but do not establish treatment causation. The record does not provide enough detail to assess event timing, attribution, or the full safety experience. It also does not state why the study was terminated. Termination should not be interpreted as evidence about efficacy or safety without a reported reason and outcome analysis.
In short, the record is informative about the study’s question, design, enrollment, and some recorded safety information. It is not a complete report of the trial’s primary efficacy findings or statistical analysis. No conclusion about whether the combination did or did not meet its response objective can be drawn from the posted results in this registry record.
13. Why This Trial Matters Statistically
This trial illustrates why the design and completeness of an outcome report matter alongside the clinical question. The registry describes a focused phase 2 objective: assessing response to oxaliplatin plus docetaxel in previously untreated non-small cell lung cancer. It also identifies the response criteria and the schedule for response measurement. Those details help define what the study intended to observe.
At the same time, the record lists a single treatment group and no comparator. In general, this kind of design can describe outcomes in treated participants, but it does not directly estimate a contrast against another regimen. Statistical interpretation must match that design: a within-group summary is not equivalent to evidence of a between-treatment difference.
The primary response result is not reported in the registry record. This is consequential because enrollment and outcome definitions do not reveal what was observed. Without the response count, estimate, and an account of who was assessed, readers cannot judge the magnitude or precision of the primary outcome. The absence of a posted analysis also leaves the statistical methods and analysis population unclear.
The safety information provides another useful distinction. Counts of participants with reported events are descriptive, while causal attribution and comparisons require additional information and an appropriate design. The registry’s selected serious-event terms are not a substitute for a complete safety analysis.
As a statistical example, the study highlights the importance of separating the question a trial was designed to ask from what its registry record actually reports. A clear endpoint definition can support interpretation, but missing results and analysis details limit what can be concluded. These limitations concern the evidence available in the record; they do not establish what the unreported analyses would have shown.
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 specific to this study record is that the primary response outcome is not reported. Although the endpoint definition and assessment schedule are described, there is no reported response count, response-rate estimate, or confidence interval. The record therefore does not permit assessment of the primary objective’s observed result or precision.
The registry identifies a single-group design, with no separate comparator. This prevents a direct treatment comparison within the study. The enrolled count is 15, but the record does not report the number included in each outcome analysis or whether all enrolled participants had evaluable outcome data.
The study is marked terminated, but the reason for termination is not reported in the registry record. The record also does not explain whether the planned enrollment was reached, whether follow-up was complete, or how the termination affected data collection. A primary completion date is listed, but it does not answer those questions.
Statistical methods and analysis populations are not detailed, and no analyses are listed. The handling of missing observations, the approach to multiple outcomes, and any interim analyses are not reported in the registry record. Results for the secondary outcomes of time to progression and duration of response are also not reported.
For safety, the record provides participant counts and selected serious-event terms but does not report timing, attribution, event duration, or a full accounting of the safety experience. The relationship between the grade 3 and 4 safety objective and the serious-event summaries is not explained. These limitations restrict interpretation of both efficacy and safety information in the registry.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer — NCT00145418.
- Registry record last updated 2014-06-30; status last verified 2014-06.
- Results first posted 2013-01-31.
- 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
NCT00145418 is a phase 2, single-group study of oxaliplatin plus docetaxel as first-line therapy for previously untreated, unresectable stage IV or IIIB non-small cell lung cancer. Oncology Specialists, S.C. is listed as the sponsor. The registry records 15 enrolled participants, no masking, a start date of 2005-02, a primary completion date of 2009-08, and terminated status.
The primary objective was response rate by RECIST criteria, with response measured every 2 cycles until disease progression. Time to progression, duration of response, and a safety objective are listed as secondary outcomes. The primary response result and secondary outcome results are not reported in the registry record. No analyses are listed.
The safety record reports serious adverse events in 9 of 15 participants and other adverse events in 15 of 15 participants. Because the study has a single group and lacks a recorded comparator, these safety counts are descriptive rather than comparative.