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 Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer (NCT00088907), a randomized phase 3 study. The primary outcome is Overall Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00088907 |
| Phase | Phase 3 |
| Condition | Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 270 |
| Arms in the primary outcome | 2 |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Patients with recurrent or metastatic head and neck cancer who had performance status 2 or had been previously treated. The primary analysis included eligible and treated patients. The registry record describes the condition as recurrent and metastatic head and neck cancer; it does not give additional eligibility details in the posted results.
Intervention
Docetaxel with gefitinib, also identified as ZD1839 or Iressa. The posted regimen describes docetaxel administered intravenously on days 1, 8, and 15, with oral gefitinib once daily on days 1-28 of each cycle.
Comparator
Docetaxel with oral placebo. The docetaxel schedule was the same as in the gefitinib arm, and placebo was taken once daily on days 1-28. Courses repeated every 28 days in both arms.
Primary question
Did overall survival differ between the docetaxel-plus-gefitinib and docetaxel-plus-placebo groups? Overall survival was defined as time from registration to death from any cause. The registry reports a log-rank comparison and arm-specific median estimates with 95% confidence intervals.
The trial was randomized, double-masked, and parallel-group. Its stated rationale was to compare docetaxel with and without gefitinib in patients with metastatic or locally recurrent disease. The registry record identifies time to progression and overall response rate as secondary outcomes. It does not report a separate registry analysis for those secondary outcomes, so recalculated comparisons should be read as exploratory rather than as replacements for an analysis specified by the trial team.
3. Trial Design
This was a phase III randomized, placebo-controlled trial with a parallel-group design and double masking. The registry describes the comparison as docetaxel plus gefitinib versus docetaxel plus placebo. The enrollment target recorded in the registry was 270. The registry lists the National Cancer Institute as sponsor and records the status as terminated. The reason for termination is not reported in the registry record.
In both arms, docetaxel was administered intravenously over 30-60 minutes on days 1, 8, and 15. Participants in the comparator arm took oral placebo daily on days 1-28. Participants in the other arm took oral gefitinib daily on days 1-28; the arm description specifies a 250 mg dose and continuation until progression. Courses repeated every 28 days. The registry describes the primary analysis population as eligible and treated patients.
The overall-survival results include 117 participants in the docetaxel-and-placebo arm and 122 in the docetaxel-and-gefitinib arm. Those analysis counts need not match the enrollment target: they describe the posted primary outcome analysis, while enrollment is the trial-level figure in the registry. The registry record does not provide an explanation for the distinction. It also does not report the allocation ratio, sequence-generation method, concealment procedures, or details of how masking was maintained.
The primary outcome was overall survival, defined as time from registration to death from any cause. The registry lists time to progression and overall response rate as secondary outcomes. Follow-up for the primary outcome was assessed every 3 months if a patient was less than 2 years from study entry, then every 6 months if 2-5 years from entry; no specific requirements were given for patients more than 5 years from entry. The start date recorded is 2004-08 and primary completion is recorded as 2009-05. The registry does not describe the trial's statistical planning assumptions or the reason it was terminated.
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.
Randomized Study (Step 1)
| Stage | Arm I (Docetaxel and Placebo) | Arm II (Docetaxel and Gefitinib) |
|---|---|---|
| STARTED | 136 | 134 |
| Treated | 129 | 124 |
| Eligible | 117 | 122 |
| Eligible and Treated | 117 | 122 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 136 | 134 |
Reasons for not completing this period:
| Reason | Arm I (Docetaxel and Placebo) | Arm II (Docetaxel and Gefitinib) |
|---|---|---|
| Lack of Efficacy | 55 | 62 |
| Adverse Event | 14 | 19 |
| Death | 11 | 12 |
| Withdrawal by Subject | 10 | 15 |
| complicating disease | 3 | 1 |
| unknown/not specify | 24 | 13 |
| ineligible or not start protocol therapy | 19 | 12 |
Single Gefitinib Treatment (Step 2)
| Stage | Arm I (Docetaxel and Placebo) | Arm II (Docetaxel and Gefitinib) |
|---|---|---|
| STARTED | 24 | 0 |
| Treated | 19 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 24 | 0 |
Reasons for not completing this period:
| Reason | Arm I (Docetaxel and Placebo) | Arm II (Docetaxel and Gefitinib) |
|---|---|---|
| Lack of Efficacy | 16 | 0 |
| Death | 1 | 0 |
| unknown/not specify | 2 | 0 |
| not start protocol therapy | 5 | 0 |
Analysis population for the primary outcome, as defined in the registry: eligible and treated patients
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.
Population: The primary population was eligible and treated patients in the study. All study results were based on the primary population except for adverse event results. In total, 136 patients enrolled on arm I, but 19 patients were ineligible/no protocol therapy. 134 patients entered arm II, 12 of them were not eligible/not starting protocol therapy.
| Characteristic | Unit | Arm I (Docetaxel and Placebo) | Arm II (Docetaxel and Gefitinib) | Total |
|---|---|---|---|---|
| Participants analysed | 117 | 122 | 239 | |
| Age, Continuous | years | 61 (28 to 86) | 60 (41 to 84) | 60 (28 to 86) |
| Sex: Female, Male: Female | Participants | 25 | 24 | 49 |
| Sex: Female, Male: Male | Participants | 92 | 98 | 190 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival, measured over assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Overall survival measures the time from registration until death from any cause. It is a time-to-event outcome: each participant contributes follow-up information until death or the end of the available observation period. The registry specifies that all eligible and treated patients were included in the analysis. The outcome is not limited to deaths attributed to cancer, because the definition includes death from any cause.
For this endpoint, the registry reports the median overall survival in each arm and a 95% confidence interval for each median. A median is the time by which half of the relevant survival distribution has experienced the event, as estimated from the available follow-up. It describes the center of the observed time-to-event experience; it does not by itself describe the entire survival pattern or establish that the arms differ.
Overall survival is used in clinical trials because it is a direct outcome that can be defined without deciding whether a particular cause of death is related to treatment. Comparing the full time-to-event experience also uses information about when events occur, rather than treating every death as if it happened at the same point. General statistical context: time-to-event methods are useful when follow-up duration varies or some participants have not experienced the event by the end of observation. The registry record does not provide the amount of censoring or a detailed account of missing follow-up.
The registry specifies follow-up assessments at the stated intervals, but does not report a separate estimate of the effect as a hazard ratio. The reported inferential comparison is a log-rank test. The arm-specific medians and their confidence intervals therefore answer a descriptive question, while the log-rank result addresses a comparison across the observed survival curves.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The median overall survival was 5.98 months in the docetaxel-and-placebo arm, with a 95% confidence interval from 4.93 to 7.43 months. In the docetaxel-and-gefitinib arm, the median was 7.33 months, with a 95% confidence interval from 5.75 to 8.44 months. These are arm-specific estimates, not a direct estimate of the difference between the treatment strategies.
The registry reports a log-rank p-value of 0.60 for the comparison. This result does not provide evidence of a statistically detectable difference in the overall survival experience under the reported test. It should not be read as proof that the strategies have identical effects. A p-value describes how compatible the observed data are with a specified null model, under the test's assumptions; it is not the probability that the null hypothesis is true and does not quantify the size or clinical importance of a possible effect.
The confidence intervals around the medians indicate uncertainty in the individual arm estimates. They overlap, but overlap or non-overlap of arm-specific confidence intervals is not itself the formal test of the between-arm difference. The log-rank test is the registry's reported comparison. No confidence interval for a between-arm survival effect or hazard ratio is reported in the registry record, so the precision of a comparative survival estimate cannot be assessed from such a measure.
The primary result should be kept distinct from the secondary response outcome. For overall response rate, the posted arm estimates are 4.3% with a 95% confidence interval from 1.4% to 9.7% for docetaxel plus placebo, and 9.8% with a 95% confidence interval from 5.2% to 16.6% for docetaxel plus gefitinib. A recalculated unadjusted risk difference is 0.056, with a 95% confidence interval from -0.009 to 0.120 and an unadjusted p-value of 0.094. The interval includes zero, and the unadjusted comparison is not the trial's reported primary analysis. It should not displace the survival result or be treated as confirmatory evidence.
Overall, the posted primary analysis reports no statistically detectable survival difference by the log-rank test. The arm-specific estimates remain uncertain, and the record does not provide a comparative survival effect estimate with a confidence interval. The result therefore supports a cautious description of what the registered analysis found, not a claim that one strategy is superior, equivalent, or ineffective.
9. Statistical Methods Explained
Overall survival is a time-to-event outcome because the endpoint records both whether death occurred and the time from registration to death. General statistical context: a time-to-event analysis can retain information from participants who are still being followed without an observed event at the analysis cutoff. Their follow-up is censored at the last time their status is known, rather than being treated as if an event occurred then. The registry record does not report censoring counts, the analysis cutoff, or details of follow-up completeness.
What does a median survival estimate describe?
The median is a point on the estimated survival distribution: it marks the time at which the estimated proportion surviving reaches one half. Here, the registry reports a median and 95% confidence interval separately for each arm. Those intervals express uncertainty around each arm's median estimate. They are not a confidence interval for the contrast between arms, and subtracting or otherwise contrasting the two medians would not reproduce the reported log-rank analysis.
General statistical context: a confidence interval gives a range of values compatible with the data and the method used, at the stated confidence level. It does not guarantee that the true value lies within that particular interval, nor does it give the probability that a treatment effect is beneficial. Its width reflects precision as well as the observed data. No confidence interval for a comparative survival effect is reported in the registry record.
What does the log-rank test compare?
The registry reports a log-rank test for overall survival, with p = 0.60. In general, the log-rank test compares the event patterns over follow-up between groups, taking account of the timing of events and the risk sets at those times. It is not simply a comparison of the medians. Its p-value summarizes how unusual the observed separation in event patterns would be under the test's null hypothesis and assumptions. It does not state the probability that the treatments are the same, and it does not measure the magnitude of a difference.
The log-rank test is commonly interpreted alongside an effect estimate, such as a hazard ratio, and its confidence interval. The registry record does not report a sponsor hazard ratio for this result. No recalculated comparative survival estimate is presented, and the record does not include enough posted summary information to derive one using the permitted simple re-calculation approach. The reported log-rank result therefore takes precedence for the primary survival comparison.
How should the response outcome be read?
Overall response rate is a binary outcome: participants are classified according to whether they met the response definition. The posted percentages are accompanied by arm-specific 95% confidence intervals. A recalculated, unadjusted risk difference compares the response proportions directly, expressed on the probability scale. Its estimate is 0.056, with a 95% confidence interval from -0.009 to 0.120. The corresponding unadjusted p-value is 0.094. Because this is a simple re-calculation from posted summary counts, it is not a substitute for a sponsor analysis or a prespecified analysis plan. No sponsor-reported analysis for this secondary outcome appears in the registry record.
General statistical context: an interval for a risk difference that includes zero is compatible with no difference under the interval method, as well as with effects in either direction within the interval. That uncertainty matters even when the observed arm percentages differ. The response comparison is unadjusted, and the record does not describe whether response assessments, evaluability criteria, or missing response data were handled in a particular way.
How should planning illustrations be interpreted?
The planning figures are illustrations computed from the observed response effect, not the trial's own design calculations. They use a two-sided significance level of 0.05, equal allocation, and a normal approximation. The displayed scenarios consider planning for 100%, 75%, and 50% of the observed effect. For 80% power, the listed participants per arm are 332, 536, and 1,084, respectively; for 90% power, they are 444, 717, and 1,450, respectively. These are planning illustrations, not observed power, and they do not establish that the trial was designed to detect the observed response difference. The registry record does not report the trial's own sample-size assumptions or justification.
General statistical context: smaller target effects generally require more information to detect reliably, which is why planning for a fraction of the observed effect can yield larger illustrations. Such estimates depend on the assumptions used and should not be treated as a retrospective score of whether a completed trial succeeded. The registry record does not report whether interim analyses were planned or conducted, what significance level was used for the primary survival test, or how the original design addressed multiple outcomes.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Log Rank | not reported | 0.600 |
The sponsor-reported primary comparison is the log-rank test for overall survival, with p = 0.60. That analysis is the relevant result for the registered primary endpoint. The arm-specific medians are descriptive estimates, while the log-rank test compares the observed time-to-event patterns across follow-up. The registry record does not report a sponsor hazard ratio or a confidence interval for a between-arm survival effect.
No recalculated primary survival comparison is available from the posted summary statistics. Accordingly, there is no competing recalculated survival p-value or effect estimate to set against the sponsor's test. The sponsor's own analysis takes precedence when a recalculation conflicts with it; no discrepancy is indicated for this record. The appropriate reading is therefore the reported log-rank result, alongside the uncertainty in the arm-specific median estimates.
For overall response rate, the record does not list a sponsor-reported statistical comparison. The unadjusted risk difference and its p-value are recalculations from posted response summaries and should be treated as exploratory. They do not supersede the primary survival analysis, and the registry record does not establish that the response comparison was the trial team's planned inferential test.
11. Multiplicity, Missing Data and Analysis Populations
The registry identifies overall survival as the primary outcome and lists time to progression and overall response rate as secondary outcomes. It does not report a multiplicity adjustment, a testing hierarchy, or rules for deciding how secondary outcomes would be interpreted alongside the primary endpoint. Without those details, unadjusted secondary comparisons should be treated cautiously, especially when more than one endpoint is considered.
The registry record does not report whether interim analyses were planned or conducted, whether early stopping boundaries were used, or how any interim testing would have affected the final analysis. The trial status is listed as terminated, but the reason for termination is not reported in the registry record. Termination alone does not establish that the trial stopped for benefit, harm, futility, or any other specific reason.
The primary analysis population is described as eligible and treated patients. The record does not provide a fuller definition of eligibility for analysis, explain exclusions from the randomized population, or state whether an intention-to-treat analysis was conducted. The primary outcome counts are 117 in the docetaxel-and-placebo arm and 122 in the docetaxel-and-gefitinib arm, while the recorded enrollment is 270; the registry does not explain the relationship among these figures.
Missing-data handling is not reported in the registry record. For overall survival, the record does not state how participants lost to follow-up were handled or give censoring information. For response, it does not describe the response-evaluable population, missing assessments, or any imputation procedure. The record also does not state whether sensitivity analyses were performed. These omissions limit assessment of how robust the results are to incomplete follow-up, exclusions, and analytic choices.
The sample-size illustrations are based on the observed response effect and specified planning assumptions; they are not the trial's own design calculation. The registry record does not report the original sample-size justification, the target effect for the primary endpoint, or the planned power. The illustrations should therefore not be used to infer the trial's intended detectable effect or its statistical adequacy.
12. 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 |
|---|---|---|---|
| Step 1: Docetaxel+Placebo | 64 | 129 | 49.6% |
| Step 1: Docetaxel+ZD1839 | 61 | 124 | 49.2% |
| Step 2: ZD1839 | 2 | 19 | 10.5% |
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 |
|---|---|
| Step 1: Docetaxel+Placebo | 16 of 129 |
| Step 1: Docetaxel+ZD1839 | 25 of 124 |
| Step 2: ZD1839 | 2 of 19 |
Most frequent serious adverse event terms
| Event term | Organ system | Step 1: Docetaxel+Placebo | Step 1: Docetaxel+ZD1839 | Step 2: ZD1839 |
|---|---|---|---|---|
| Fatigue | General disorders | 21 of 129 | 14 of 124 | 1 of 19 |
| Diarrhea | Gastrointestinal disorders | 3 of 129 | 16 of 124 | 0 of 19 |
| Dehydration | Metabolism and nutrition disorders | 6 of 129 | 8 of 124 | 0 of 19 |
| Lung infection | Infections and infestations | 9 of 129 | 5 of 124 | 0 of 19 |
| Lymphocyte count decreased | Investigations | 9 of 129 | 4 of 124 | 0 of 19 |
| Nausea | Gastrointestinal disorders | 5 of 129 | 7 of 124 | 0 of 19 |
| White blood cell decreased | Investigations | 5 of 129 | 6 of 124 | 0 of 19 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 6 of 129 | 5 of 124 | 0 of 19 |
| Anorexia | Metabolism and nutrition disorders | 3 of 129 | 6 of 124 | 0 of 19 |
| Neutrophil count decreased | Investigations | 4 of 129 | 4 of 124 | 0 of 19 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Step 1: Docetaxel+Placebo | Step 1: Docetaxel+ZD1839 | Step 2: ZD1839 |
|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 10 of 129 | 16 of 124 | 0 of 19 |
| Fatigue | General disorders | 11 of 129 | 14 of 124 | 1 of 19 |
| Nausea | Gastrointestinal disorders | 6 of 129 | 11 of 124 | 0 of 19 |
| Diarrhea | Gastrointestinal disorders | 4 of 129 | 7 of 124 | 1 of 19 |
| White blood cell decreased | Investigations | 4 of 129 | 7 of 124 | 0 of 19 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 0 of 129 | 7 of 124 | 0 of 19 |
| Alopecia | Skin and subcutaneous tissue disorders | 0 of 129 | 0 of 124 | 2 of 19 |
| Dry skin | Skin and subcutaneous tissue disorders | 0 of 129 | 0 of 124 | 1 of 19 |
Serious events with the highest arm-level rate: fatigue (16.3%), diarrhea (12.9%), lymphocyte count decreased (7.0%), lung infection (7.0%), dehydration (6.5%).
The registry lists serious adverse events affecting 64 participants in the docetaxel-and-placebo group and 61 in the docetaxel-and-ZD1839 group. The corresponding at-risk counts are 129 and 124. A separate Step 2 ZD1839 group lists 2 participants affected and 19 at risk. These safety groups are not the same as the primary overall-survival analysis groups, and the registry record does not explain the relationship between the Step 2 group and the randomized comparison.
The most frequently listed serious adverse event terms are fatigue, 16.3%; diarrhea, 12.9%; lymphocyte count decreased, 7.0%; lung infection, 7.0%; dehydration, 6.5%; and nausea, 5.6%. These percentages describe the posted serious-event listings; they are not a complete safety profile. The registry record does not provide the full event listings or explain whether the figures represent participants with at least one event, event episodes, or a particular follow-up window.
General statistical context: safety counts need their denominators and group definitions to be interpreted. Differences in the number at risk, exposure duration, follow-up, and event ascertainment can affect comparisons. The posted figures alone do not establish that a treatment caused an event or that event rates differ between strategies. No medical conclusion should be drawn from these serious-event listings without the missing context.
13. What the Result Does, and Does Not, Mean
The primary result describes the registry's comparison of overall survival between docetaxel plus placebo and docetaxel plus gefitinib. The log-rank test yielded p = 0.60. This is a failure to detect a statistically significant difference by that test, not proof that the groups had identical survival or that a meaningful difference is impossible. The arm-specific medians are estimates with uncertainty, and no comparative survival effect estimate with a confidence interval is reported.
The response outcome has an unadjusted recalculated comparison, but it is secondary and no sponsor analysis is listed. Its confidence interval spans values on both sides of zero. This does not establish a reliable treatment difference, and it should not be promoted to a confirmatory finding. The results for response and survival address different outcomes and cannot be treated as interchangeable measures.
General statistical context: a non-significant test can arise when a true effect is small, when estimates are imprecise, or when the data do not show a sufficiently clear separation under the chosen analysis. The p-value alone cannot distinguish among those possibilities. Interpreting a trial also requires the design assumptions, analysis population, missing-data handling, and the precision of effect estimates. Several of those details are not reported in the registry record.
The posted information does not establish whether the treatment strategies are equivalent, whether either is preferable, or whether the results apply to populations beyond the trial's stated eligibility group. It also does not explain why the trial was terminated or provide the protocol's statistical plan. The defensible conclusion is limited: the registry reports the stated arm-specific survival estimates and a log-rank result that did not show a statistically detectable difference, with important uncertainty and reporting gaps.
14. Why This Trial Matters Statistically
This trial illustrates why a primary endpoint's analysis should be interpreted according to the question it was designed to answer. Overall survival is measured as time to death from any cause, and the sponsor-reported log-rank test compares event patterns over follow-up rather than simply comparing arm medians. Reading the medians alone could obscure the fact that the formal comparison concerns the broader time-to-event experience.
It also demonstrates the distinction between a trial's own analysis and a recalculation from posted summaries. The registry reports a primary log-rank result, while the overall-response comparison is an unadjusted recalculation because no sponsor analysis is posted for that outcome. Those results have different statistical status. The recalculation can help describe uncertainty in the posted response summaries, but it cannot be treated as the trial's prespecified inferential conclusion.
The record highlights how incomplete reporting limits interpretation. It does not include a comparative survival effect estimate and confidence interval, details of missing-data handling, a multiplicity strategy, or the original sample-size justification. The termination status is recorded without a reason. These gaps make it difficult to assess the precision of a comparative survival effect, the robustness of the analyses, or how the trial's findings relate to its original design assumptions.
Finally, planning illustrations based on an observed secondary effect are not evidence of observed power and do not reconstruct the study's design. Keeping descriptive estimates, sponsor-reported tests, recalculations, and planning scenarios separate is essential to a statistically disciplined reading of this record.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record leaves important aspects of the trial design and analysis unspecified. Although the study is identified as randomized and double-masked, the record does not describe sequence generation, allocation concealment, masking procedures, or the allocation ratio. It does not explain why the trial was terminated. The reason should not be inferred from the termination status alone.
For overall survival, the record gives arm-specific medians and confidence intervals and a log-rank p-value, but no comparative hazard ratio or confidence interval. It does not report the number of deaths, censoring information, duration of follow-up, or detailed handling of participants lost to follow-up. As a result, the comparative effect's magnitude and precision cannot be fully assessed from the posted primary results.
The primary analysis population is described as eligible and treated patients, but the registry does not provide a detailed account of exclusions or clarify whether all randomized participants were analyzed in their assigned groups. The overall-survival analysis counts differ from the recorded enrollment figure; the record does not explain this. Missing-data methods and sensitivity analyses are also not reported.
Reporting for secondary outcomes is incomplete. Although time to progression is listed, no numerical result is included in the information summarized in the registry record. Overall response rate has posted arm estimates, but no sponsor-reported comparison. The response definition, assessment procedures, evaluable population, and handling of missing assessments are not described. The record also does not state how multiplicity was addressed across endpoints.
The safety listings do not supply a full account of adverse events, exposure duration, or the relationship of the Step 2 group to the randomized comparison. Finally, the registry record does not report the original sample-size justification, planned statistical analysis details, or interim-analysis plans. These limitations constrain interpretation; they do not, by themselves, determine the direction or validity of the trial's findings.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer — NCT00088907.
- Registry record last updated 2015-05-06; status last verified 2013-07.
- Results first posted 2015-05-06.
- 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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19. Record Summary
The registry describes a phase III randomized, double-masked, parallel-group, placebo-controlled trial of docetaxel plus gefitinib versus docetaxel plus placebo in recurrent or metastatic head and neck cancer. Enrollment is recorded as 270, the sponsor as the National Cancer Institute, and status as terminated. The reason for termination is not reported in the registry record.
Overall survival was the primary outcome, defined as time from registration to death from any cause. The posted medians were 5.98 months for docetaxel plus placebo and 7.33 months for docetaxel plus gefitinib; the sponsor-reported log-rank p-value was 0.60. Overall response rate is also posted, but its comparison is an unadjusted recalculation rather than a sponsor-reported analysis.
The record does not report a comparative survival effect estimate with a confidence interval, the original sample-size justification, multiplicity procedures, or missing-data methods. The results support a cautious description of the posted analyses, not a conclusion of equivalence or a definitive claim about treatment effects.