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 OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer (NCT00076310), a na phase 2 study. The primary outcome is Overall Response Assessment (Radiographic RECIST).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00076310 |
| Phase | Phase 2 |
| Condition | Head and Neck Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 50 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
People with metastatic or recurrent head and neck squamous cell cancer. The registry record identifies the condition as head and neck cancer and describes the study population more specifically in its official title and treatment summary.
Intervention
The study regimen combined OSI-774, cisplatin, and docetaxel. The listed regimen describes cisplatin 75 mg/m^2 and docetaxel 60 mg/m^2 intravenously every 21 days, with OSI-774 100 mg orally daily. A possible OSI-774 dose escalation to 150 mg is described as dependent on prior dose toleration.
Comparator
No concurrent comparator is described. This was a single-group study, and the allocation field is recorded as not applicable. The treatment group therefore cannot be read as one side of a randomized, like-for-like comparison.
Primary question
The primary endpoint asks how many participants have each radiographic response category under RECIST v.1.0: complete response, partial response, stable disease, progressive disease, or not evaluable. The assessment is specified after 2 cycles of treatment (6 weeks), with confirmation 4-6 weeks thereafter.
The registry’s stated purpose was to study whether adding OSI-774 to cisplatin and docetaxel was effective in metastatic or recurrent head and neck cancer, and to study safety. The endpoint definition tells readers what response categories were intended to be assessed; it does not, by itself, establish how many participants were assessed or what responses occurred. The registry record does not report the primary response counts, so the magnitude and precision of the observed response outcome cannot be described from this record.
Because there is no control group, the study’s response observations would describe outcomes among participants receiving the combination, rather than estimate a treatment contrast against another regimen or against no treatment. That distinction matters: a response proportion in a single group does not separate the effect of the regimen from other influences on outcomes. The record also does not report an analysis comparing response with a prespecified benchmark. The appropriate statistical reading is therefore descriptive and limited to the recorded study design and endpoint definition.
3. Trial Design
This is a phase II, single-group clinical study sponsored by M.D. Anderson Cancer Center. The registry records enrollment of 50 and marks the study as completed. Allocation is listed as not applicable, and masking is listed as none. These design details indicate that the registry does not describe randomized assignment to competing treatment groups or masking of treatment assignment.
The intervention group is titled “Cisplatin + Docetaxel + OSI-774.” Its description specifies cisplatin 75 mg/m^2 intravenously every 21 days, docetaxel 60 mg/m^2 intravenously every 21 days, and OSI-774 100 mg orally each day. The description allows a possible increase of OSI-774 to 150 mg depending on prior dose toleration. It states that daily OSI-774 continues until a study endpoint or removal from the study. These are the registry’s regimen details; the record does not explain how many participants received each dose level or how dose changes were implemented.
The primary outcome is a participant count classified by radiographic RECIST v.1.0 response. Assessment is specified after 2 cycles (6 weeks) and confirmation 4-6 weeks thereafter. The registry also lists progression-free survival and overall survival duration assessments, and toxicity measured as the number of adverse events. Although it reports 3 outcome measures, it lists 0 analyses. The record does not provide results for the response endpoint or the listed secondary outcomes.
The record labels the study completed, but the available information does not establish whether every enrolled participant completed the response assessment, whether follow-up was complete, or how exclusions and missing outcome data were handled. The statistical plan, analysis population, and any protocol changes are not reported in the registry record. Without a comparator and without reported outcome analyses, this record supports a description of the intended design and outcome definitions, but not a comparative estimate of treatment effect.
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 | Experimental (OSI-774 Erlotinib) |
|---|---|
| STARTED | 50 |
| COMPLETED | 33 |
| NOT COMPLETED | 17 |
Reasons for not completing this period:
| Reason | Experimental (OSI-774 Erlotinib) |
|---|---|
| Adverse Event | 9 |
| Death | 7 |
| patient withdrawal | 1 |
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 | Experimental (OSI-774 Erlotinib) |
|---|---|---|
| Participants analysed | 50 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 43 |
| Age, Categorical: >=65 years | Participants | 7 |
| Age, Continuous | years | 57 (39 to 72) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 42 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 49 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 48 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 50 |
| Distribution of categorical clinical characteristics among evaluable patients: Performance Status 0 | Participants | 7 |
| Distribution of categorical clinical characteristics among evaluable patients: Performance Status 1 | Participants | 41 |
| Distribution of categorical clinical characteristics among evaluable patients: Performance Status 2 | Participants | 2 |
| Distribution of categorical clinical characteristics among evaluable patients: Primary Site: Oropharynx | Participants | 19 |
| Distribution of categorical clinical characteristics among evaluable patients: Primary Site: Oral Cavity | Participants | 15 |
| Distribution of categorical clinical characteristics among evaluable patients: Primary Site: Larynx | Participants | 11 |
| Distribution of categorical clinical characteristics among evaluable patients: Primary Site: Hypopharynx | Participants | 3 |
| Distribution of categorical clinical characteristics among evaluable patients: Primary Site: Unknown | Participants | 2 |
| Distribution of categorical clinical characteristics among evaluable patients: Disease Status at Entry: Locoregional Recurrence | Participants | 31 |
| Distribution of categorical clinical characteristics among evaluable patients: Disease Status at Entry: Metastatic Disease | Participants | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Response Assessment (Radiographic RECIST), measured over after 2 cycles of treatment (6 weeks) and confirmed 4-6 weeks thereafter.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is an overall response assessment based on radiographic RECIST v.1.0 criteria. It is reported as a count of participants, with response categories defined as complete response, partial response, stable disease, progressive disease, and not evaluable. Complete response means disappearance of all target lesions. Partial response requires at least a 30% decrease in the sum of the longest diameters of target lesions. Stable disease falls between the criteria for partial response and progressive disease. Progressive disease requires at least a 20% increase in the sum of the longest diameters from the smallest sum diameter recorded. Imaging is specified by CT or MRI.
Response categories provide a structured way to describe how measurable lesions change on imaging during treatment. In general, using consistent criteria helps make assessment more reproducible than relying on an undefined impression of change. Counting participants in each category also makes clear that not every assessed participant necessarily has a measurable response: some may have stable disease, progressive disease, or an assessment that is not evaluable.
The registry specifies assessment after 2 cycles of treatment (6 weeks), with confirmation 4-6 weeks thereafter. That timing defines the intended assessment window; it does not establish that all participants had an assessment or confirmation. The registry record does not report the observed counts by response category, the number assessed, or how not-evaluable and missing assessments were treated in the analysis. Consequently, the endpoint definition can be explained, but the response result and its statistical precision cannot be evaluated from the reported record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive point is that the registry describes a single treatment group and a primary response endpoint, but does not report the response counts or a statistical analysis of that endpoint. The enrollment is recorded as 50, yet that number alone does not tell readers how many participants had an evaluable radiographic assessment, how responses were distributed, or how uncertain an estimated response proportion would be. No numerical response estimate or confidence interval is reported in the registry record.
A single-group phase II study can describe outcomes observed among people who received a regimen. It cannot, without a concurrent comparator or a justified external comparison, show what those same participants’ outcomes would have been under a different treatment. Differences in disease characteristics, supportive care, assessment timing, and other factors can affect outcomes across groups or across studies. Thus, even if a response count were available, it would not by itself establish that the regimen caused the responses or that it improves outcomes relative to another option.
The response endpoint is a categorical count, not a time-to-event estimate. The record separately lists progression-free survival and overall survival duration assessments, but provides no results for them. It also lists toxicity as an outcome and includes adverse-event summaries. Those safety data should be read as event reporting for the study group, not as a comparative safety estimate. The record does not provide a control group, exposure-adjusted event rates, or enough detail to determine the timing and attribution of the reported events.
The safety summary lists 50 at risk and 29 affected for serious adverse events, 50 at risk and 50 affected for other adverse events, and 48 deaths. The listed serious-event terms include dehydration at 18.0%, death at 14.0%, diarrhea at 10.0%, infection at 10.0%, febrile neutropenia at 8.0%, and hypotension at 8.0%. These entries do not establish that an event was caused by the regimen. The registry record does not give the definitions, observation windows, attribution rules, or analysis details needed to interpret these figures as a causal risk.
In particular, the safety summary includes both a deaths count of 48 and a serious-event term “Death” at 14.0%. The record does not explain the relationship between those entries, so they should not be treated as directly interchangeable measures. The reported response and survival results, the analysis population, and inferential statistics are not reported in the registry record. The available evidence therefore supports a careful account of the study’s design and listed outcomes, but not a conclusion about comparative benefit, cause of adverse events, or the precision of an unreported treatment effect.
9. Statistical Methods Explained
The methods can be understood by separating what the registry specifies from what it does not report. It identifies a phase II, single-group study with masking listed as none and allocation listed as not applicable. It defines a radiographic response endpoint and lists additional survival and toxicity outcomes. It does not report the statistical analysis plan, primary response counts, confidence intervals, hypothesis tests, or the analysis population. Those omissions limit how far statistical interpretation can go.
What does a single-group design estimate?
In general, a single-group study describes outcomes among participants receiving the study regimen. If an outcome proportion is reported, it summarizes the observed frequency in that group. It does not directly estimate the difference between the regimen and a comparator, because there is no concurrently assigned comparison group. Random allocation, when used, helps make groups comparable on average; this study’s registry entry does not describe randomization. A comparison with outcomes from another study would require careful justification and information about differences in participants, treatment, follow-up, and outcome assessment. No such comparison is reported.
The absence of masking is also relevant to interpretation, especially for outcomes that require judgment. The response criteria are radiographic and defined using RECIST v.1.0, but the record does not state whether imaging was reviewed centrally, whether assessors knew treatment details, or how disagreements were handled. The record does not report these procedures. A defined criterion can improve consistency, but it does not remove every possible source of assessment variation.
How should the response endpoint be read?
The primary outcome is a count of participants in radiographic response categories. A count is a descriptive summary. To interpret a response proportion, readers would also need the relevant denominator: for example, the number included in the analysis and the number with an evaluable scan. The registry gives an enrollment value but does not report the number assessed or the response-category counts. It therefore does not provide enough information to calculate or verify a response proportion, and no such calculation should be inferred.
RECIST v.1.0 specifies categories based on changes in target lesions. The record defines complete response as disappearance of all target lesions, partial response as at least a 30% decrease in the sum of longest diameters, and progressive disease as at least a 20% increase from the smallest recorded sum diameter. Stable disease is between the criteria for response and progression; not evaluable is also included. These operational definitions clarify how the endpoint is intended to classify imaging findings, but the registry record does not report the actual classifications or missing-assessment handling.
What do precision and statistical significance mean?
In general, a confidence interval expresses the range of values compatible with the observed data under a specified statistical model and procedure. A narrower interval indicates greater precision under those assumptions; a wider interval indicates more uncertainty. A significance test addresses whether data are sufficiently inconsistent with a specified null hypothesis, but its interpretation depends on the hypothesis, analysis plan, and assumptions. Neither a confidence interval nor a p-value is reported for the primary outcome in the registry record. Without the observed response data and analysis details, precision and statistical significance cannot be assessed.
The record lists 0 analyses. That should not be taken to mean that no analyses were conducted outside the registry; it means that no analyses are listed in this registry record. The protocol’s statistical plan, planned hypotheses, model choices, and any interim analyses are not reported in the registry record. They should not be reconstructed from the phase designation or from the type of endpoint.
What do the planning illustrations mean?
General sample-size planning asks how much information a future study would need to detect a specified effect under stated assumptions. The planning description associated with this record uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; it describes the detectable effect as a stated fraction of the observed effect. For time-to-event outcomes, the description refers to a total number of events, while other outcomes are expressed as participants per arm. These are planning assumptions, not the design of the single-group study described in the registry.
Such planning values are hypothetical illustrations. They are not observed power, do not show that this study was designed with those assumptions, and do not establish that the study had adequate power for its actual objectives. The registry record does not report the study’s own sample-size justification or the statistical plan used to choose enrollment. The observed effect needed as a planning reference is not stated in the outcome information available in this record, and no planning calculation should be treated as a trial result.
Why can adverse-event counts be difficult to compare?
In general, an adverse-event count can refer to participants who experienced at least one event or to the total number of event occurrences. These are different quantities: one participant can experience more than one event, and categories may overlap. The record labels the adverse outcome as a number of adverse events and lists participant counts in its safety summary, but does not report enough detail to establish how repeat events, overlapping categories, timing, or attribution were handled. Without a comparator, these counts describe events reported in the study group and do not estimate a relative risk.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists an overall response assessment as the primary outcome and also names progression-free survival, overall survival duration, and toxicity among the outcomes. It reports 3 outcome measures and 0 analyses. The record does not state which secondary outcomes were formally tested, which were descriptive, or how testing across multiple outcomes was handled. A prespecified multiplicity strategy, such as a hierarchy or adjustment to control the chance of false-positive findings across several tests, is not reported in the registry record.
Multiplicity matters when several outcomes or comparisons are tested: interpreting each result as if it were the only planned test can overstate the strength of evidence. That general concern cannot be quantified for this study because the registry record does not provide the analysis plan, test results, or details of any additional comparisons. It would be inappropriate to assume that a particular correction, endpoint hierarchy, or testing procedure was used.
The record also does not report how missing or unevaluable response assessments were handled. The endpoint definition includes “not evaluable,” but there is no reported count in that category and no explanation of whether such participants were included in a denominator, excluded, or handled through another rule. The number with complete follow-up for progression-free survival or overall survival is not reported. Nor are the analysis populations, exclusions, withdrawals, or reasons for missing data described.
In general, missing outcomes can affect interpretation when the chance of missingness is related to participants’ health or outcomes. A complete-case summary may differ from one that uses a different missing-data approach. Without participant flow and analysis details, readers cannot judge the direction or size of any such effect. The registry record does not report whether interim analyses occurred or how they may have affected analyses or outcome reporting.
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 |
|---|---|---|---|
| Experimental (OSI-774 Erlotinib) | 29 | 50 | 58.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Experimental (OSI-774 Erlotinib) | 48 of 50 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Experimental (OSI-774 Erlotinib) | 50 of 50 |
Most frequent serious adverse event terms
| Event term | Organ system | Experimental (OSI-774 Erlotinib) |
|---|---|---|
| Dehydration | Metabolism and nutrition disorders | 9 of 50 |
| Death | General disorders | 7 of 50 |
| Diarrhea | Gastrointestinal disorders | 5 of 50 |
| Infection | Infections and infestations | 5 of 50 |
| Febrile neutropenia | Blood and lymphatic system disorders | 4 of 50 |
| Hypotension | Vascular disorders | 4 of 50 |
| Neutropenia | Investigations | 4 of 50 |
| Hemoglobin | Blood and lymphatic system disorders | 3 of 50 |
| Nausea | Gastrointestinal disorders | 3 of 50 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 3 of 50 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Experimental (OSI-774 Erlotinib) |
|---|---|---|
| Fatigue | General disorders | 41 of 50 |
| Lymphopenia | Blood and lymphatic system disorders | 35 of 50 |
| Nausea | Gastrointestinal disorders | 33 of 50 |
| Rash/desquamation | Skin and subcutaneous tissue disorders | 31 of 50 |
| Diarrhea | Gastrointestinal disorders | 30 of 50 |
| Dysphagia | Gastrointestinal disorders | 29 of 50 |
| Anemia | Blood and lymphatic system disorders | 26 of 50 |
| Trismus | Musculoskeletal and connective tissue disorders | 20 of 50 |
| Insomnia | General disorders | 19 of 50 |
| Constipation | Gastrointestinal disorders | 18 of 50 |
Serious events with the highest arm-level rate: dehydration (18.0%), death (14.0%), diarrhea (10.0%), infection (10.0%), febrile neutropenia (8.0%).
The registry’s safety summary lists an experimental group labelled “OSI-774 Erlotinib.” It records 50 at risk and 29 affected for serious adverse events, 50 at risk and 50 affected for other adverse events, and 48 deaths. It also lists serious-event terms with percentages: dehydration at 18.0%, death at 14.0%, diarrhea at 10.0%, infection at 10.0%, febrile neutropenia at 8.0%, and hypotension at 8.0%. These are the registry’s reported entries; their definitions and observation window are not described in the available record.
The percentages should be read as reported values for the listed serious-event terms, not as evidence that those events were caused by treatment. A serious adverse event is not necessarily a treatment-related adverse event. The record does not report event attribution, onset, duration, severity grading criteria, or whether each listed term refers to participants or event occurrences. Event categories can overlap in general, so the listed terms should not be added together to infer a total.
The record lists 48 deaths and also includes “Death” among the serious-event terms at 14.0%. It does not explain how these entries relate to each other, and they should not be treated as equivalent summaries. The registry does not report a comparator or exposure-adjusted rates. These data are therefore descriptive safety reporting for the study group; they do not establish comparative risk or causation.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a phase II single-group study evaluated a combination of OSI-774, cisplatin, and docetaxel in metastatic or recurrent head and neck squamous cell cancer. It gives the intended regimen, defines a radiographic response endpoint using RECIST v.1.0, and lists survival and toxicity outcomes. It also includes safety counts and selected serious-event terms. These details help readers understand what the study set out to assess and what kinds of outcomes it recorded.
The record does not report the primary response counts, a response proportion, or a confidence interval. It does not report analyses of the listed survival outcomes, nor inferential comparisons. As a result, the posted information does not establish the size or precision of the response outcome, whether outcomes differed from a benchmark, or whether the regimen performed better or worse than another treatment. The study has no concurrent comparator in its registry design, so a causal treatment contrast is not available from this record.
The safety information also has limits. Counts of adverse events and deaths do not, by themselves, establish that treatment caused an event. The registry record does not give attribution rules, event timing, or enough context to reconcile the deaths count with the “Death” serious-event term. The listed values should be interpreted as registry safety entries, not as comparative estimates or proof of causation.
In general, a study’s design, endpoint definitions, completeness of follow-up, and analysis choices all affect how results should be understood. Here, the statistical plan, analysis populations, missing-data procedures, and multiplicity approach are not reported in the registry record. Those gaps mean that the design and outcome definitions can be described, while the efficacy and precision of the posted results cannot be assessed from the available entries. No conclusion about individual treatment decisions follows from this registry summary.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its design and endpoint make clear the difference between describing outcomes and estimating a comparative effect. A single-group study can record response categories and adverse events among participants receiving a regimen. Without a concurrent control group, however, those observations do not directly quantify how outcomes would differ under another treatment. That distinction remains important even when a trial has a clearly defined radiographic endpoint.
The RECIST-based endpoint illustrates how measurement rules can make an outcome more explicit. Complete response, partial response, stable disease, progressive disease, and not evaluable have stated meanings tied to imaging findings. At the same time, transparent definitions do not substitute for reporting the observed counts, denominators, and analysis decisions. The registry record contains the criteria and assessment timing, but not the primary response results needed to judge the endpoint’s observed magnitude or precision.
The record also illustrates why safety summaries require context. Counts, percentages, and event labels may represent different kinds of summaries, and the relationship between entries is not always clear from a registry record alone. In this case, the deaths count and the serious-event term “Death” are both listed without an explanation connecting them. Attribution, timing, and exposure information are also not reported, so the figures should not be read as a causal comparison.
Finally, the record distinguishes trial design from planning illustrations. Hypothetical sample-size calculations use explicit assumptions and are not the same as the study’s actual design or observed power. The registry does not report the study’s own sample-size justification or analysis plan. Recognizing these boundaries helps prevent a descriptive registry entry from being interpreted as a complete statistical evaluation of treatment effect.
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 principal limitation for interpreting this trial statistically is the absence of reported primary outcome results. Although the registry defines the RECIST response categories and assessment timing, it does not report the number of participants in each category, the number assessed, or an estimate with an interval. The enrollment entry alone cannot supply those missing outcome details.
The single-group design has no concurrent comparator. It can describe the study group’s outcomes if those outcomes are reported, but cannot isolate a regimen effect from other influences or estimate a randomized treatment contrast. The registry also does not report an external benchmark or an analysis comparing results with one. The lack of masking is recorded, while procedures for imaging review and response adjudication are not reported in the registry record.
Further limitations arise from incomplete analysis information. The registry lists outcome measures but no analyses. It does not report the protocol’s statistical plan, analysis populations, sample-size justification, multiplicity procedure, handling of missing or not-evaluable assessments, or whether interim analyses occurred. These details are necessary to understand which participants and outcomes contributed to any analysis and how uncertainty was assessed.
The safety data are also limited by missing context. The record does not describe event attribution, observation windows, event-level definitions, repeat-event handling, or exposure-adjusted summaries. It lists 48 deaths and a “Death” serious-event term at 14.0%, but does not explain their relationship. These entries should not be combined or interpreted as evidence of treatment causation. The record’s completed status does not establish complete follow-up or complete reporting of all outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer — NCT00076310.
- Registry record last updated 2026-07-22; status last verified 2026-07.
- Results first posted 2026-04-15.
- 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
NCT00076310 is a completed phase II, single-group study sponsored by M.D. Anderson Cancer Center. It enrolled 50 and studied OSI-774 with cisplatin and docetaxel for metastatic or recurrent head and neck squamous cell cancer. The registry lists no masking and no randomized allocation.
The primary outcome is a participant count by radiographic RECIST v.1.0 response category, assessed after 2 cycles of treatment (6 weeks) and confirmed 4-6 weeks thereafter. The registry also lists progression-free survival, overall survival duration, and toxicity outcomes. It reports 3 outcome measures and 0 analyses.
The registry record does not report the response counts, survival analyses, or inferential statistics. Its safety summary lists serious and other adverse-event counts, deaths, and selected serious-event terms. These entries are descriptive and do not establish causation or comparative risk. The statistical plan, analysis populations, and missing-data procedures are not reported in the registry record.