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 Celecoxib and Recombinant Interferon Alfa-2b in Metastatic Kidney Cancer Who Have Undergone Surgery (NCT01158534), a na phase 2 study. The primary outcome is Objective Response Rate Assessed by RECIST Criteria..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01158534 |
| Phase | Phase 2 |
| Condition | Renal Cell Cancer, Stage IV Renal Cell Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Case Comprehensive Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients with metastatic renal cell carcinoma and 3+ COX-2 tumor immunostaining. The trial title also describes patients who had undergone surgery; further eligibility details are not reported in the registry record.
Intervention
Oral celecoxib twice daily together with recombinant interferon alfa-2b given subcutaneously once daily, 5 times a week. Treatment courses repeat every 28 days while disease progression or unacceptable toxicity is absent.
Comparator
There is no separate comparison group. The trial is listed as single group, with allocation recorded as NA and masking as none.
Primary question
The primary endpoint is objective response assessed by RECIST criteria, recorded as a number of participants. The registry record does not report the response count or response rate.
The clinical question is whether an objective response was observed among patients receiving this combination in this selected trial population. The registry describes the study as a phase II trial and gives the response assessment schedule as week 4 of cycle 2 and every other cycle thereafter. The response definition concerns the best overall response recorded from treatment start until disease progression or recurrence, using the smallest measurements recorded since treatment began, including baseline, as the reference for progressive disease. Assignment of best response depends on meeting both measurement and confirmation criteria.
Because there is no separate control arm, this study cannot directly compare the combination with another treatment or with no treatment. The registry record describes the treatment and endpoint, but does not provide the primary response result. It therefore does not allow a reader to determine how many participants responded, or how precisely a response rate was estimated.
3. Trial Design
This is a phase II, single-group trial in metastatic renal cell carcinoma. The official title identifies patients with 3+ COX-2 tumor immunostaining, and the title describes patients who have undergone surgery. The registry lists an enrollment of 17. The sponsor is Case Comprehensive Cancer Center. The trial is marked completed, with a start date of 2006-03 and primary completion date of 2010-09.
All participants in the listed treatment arm receive celecoxib and recombinant interferon alfa-2b. Celecoxib is taken orally twice daily, and interferon alfa-2b is administered subcutaneously once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The record also lists laboratory and immunologic procedures, including biomarker analyses and immunohistochemistry, but does not describe their role in treatment assignment.
There is no randomized allocation, masking is listed as none, and the model is single group. These design features mean the primary endpoint describes outcomes observed in the treated group rather than a contrast between randomized groups. The registry lists overall survival, duration of response, progression-free survival, and changes in cellular immune parameters among the secondary outcomes.
The primary outcome is objective response assessed by RECIST criteria, with assessment scheduled at week 4 of cycle 2 and every other cycle thereafter. The registry record does not report the number of participants assessed, the response count, or an estimate of the response rate. It also does not report the protocol, detailed eligibility criteria, or a rationale for the planned enrollment.
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 | Celecoxib and Recombinant Interferon Alpha-2b |
|---|---|
| STARTED | 17 |
| COMPLETED | 14 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Celecoxib and Recombinant Interferon Alpha-2b |
|---|---|
| Withdrawal by Subject | 1 |
| Death | 1 |
| Other | 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 | Celecoxib and Recombinant Interferon Alpha-2b |
|---|---|---|
| Participants analysed | 17 | |
| Age Continuous | years | 62.9 (SD 9.6) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 13 |
| Region of Enrollment: United States | participants | 17 |
6. Primary Endpoint
The registry lists the primary outcome as Objective Response Rate Assessed by RECIST Criteria., measured over at week 4 of cycle 2 and every other cycle thereafter.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is objective response assessed by RECIST criteria and recorded as a number of participants. RECIST provides standardized rules for evaluating changes in measurable tumors, allowing response assessments to be made using defined measurement and confirmation criteria. In general, an objective response endpoint is used to describe whether tumors met criteria for response during treatment; it is not, by itself, a direct measure of how long a response lasts or whether outcomes differ from those under another treatment.
The registry defines best overall response as the best response recorded from treatment start until disease progression or recurrence. For progressive disease, the reference is the smallest measurements recorded since treatment began, including baseline. A participant's best response assignment depends on meeting both measurement and confirmation criteria. Assessments were scheduled at week 4 of cycle 2 and every other cycle thereafter.
The record identifies the endpoint but does not report its observed result. No response count, response proportion, confidence interval, or details of the response categories are reported in the registry record. Without those results, the endpoint definition alone cannot establish how many participants met the criteria or how precisely the response frequency was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a 17-participant, single-group phase II trial and defines objective response by RECIST criteria as the primary endpoint. It does not report the primary endpoint result. In particular, there is no posted response count, response rate, or confidence interval in the record. The clinical response question therefore remains unanswered by the recorded results, even though the endpoint and its assessment schedule are specified.
The distinction between a stated endpoint and a reported outcome is important. An endpoint describes what investigators intend to measure; an outcome result reports what was observed. The record supplies the former but not the latter for objective response. No conclusion about the frequency of response or its statistical precision can be drawn from the endpoint definition or enrollment alone.
The study has one treatment group rather than a randomized control group. Any outcome data from such a design describe participants receiving the combination, but do not isolate the effect of the combination from other influences. Without a concurrent comparator, differences attributable to disease course, participant selection, or other factors cannot be separated from treatment-related differences. This is a general limitation of interpreting single-group treatment outcomes, not a claim about what occurred in this trial.
The safety results report that 2 of 17 participants had a serious adverse event and that 17 of 17 had an other adverse event. The record lists seizures and thrombosis/embolism among the leading serious adverse event terms, each with a reported rate of 5.9%. These figures describe recorded event counts in the listed group. The registry does not report whether events were judged related to treatment, how events were defined or collected, or whether all participants had the same duration of follow-up.
Overall survival, duration of response, progression-free survival, and changes in cellular immune parameters are listed as secondary outcomes. Their numerical results are not reported in the registry record. The record therefore offers limited grounds for interpreting either benefit-related outcomes or the completeness of outcome reporting. No comparative treatment effect can be estimated from the single-group design, and the primary response estimate itself is unavailable.
9. Statistical Methods Explained
What does a single-group design show?
In a single-group trial, participants receive the listed intervention and outcomes are described within that group. General statistical interpretation separates a within-group outcome from a treatment comparison. A comparison requires outcomes under an alternative condition, such as a separate control group. Without that contrast, observed outcomes do not by themselves identify what would have happened to the same participants under another treatment.
This trial is listed as single group, with allocation NA and masking none. There is no separate comparator arm in the registry record. Consequently, the design can describe the treated group but cannot estimate a randomized between-group difference. This is not a judgment about the conduct of the trial; it defines the type of inference supported by the design.
What does the primary endpoint capture?
The primary endpoint is objective response assessed by RECIST criteria, expressed as a number of participants. The registry defines best overall response as the best response recorded from treatment start until disease progression or recurrence. Progressive disease is assessed against the smallest measurements recorded since treatment began, including baseline, and best response assignment requires both measurement and confirmation criteria.
In general, a response endpoint summarizes whether participants met specified tumor response criteria during observation. It differs from time-to-event outcomes such as progression-free survival, which concern the timing of an event, and overall survival, which concerns time until death. The record lists these time-to-event outcomes as secondary outcomes but does not report their results. The objective response assessment schedule is week 4 of cycle 2 and every other cycle thereafter.
How should uncertainty be understood?
A confidence interval is a general statistical way to express the uncertainty around an estimate. Its width reflects the precision of the estimate under the method used; a wider interval indicates greater uncertainty. A point estimate without an interval gives less information about precision. The registry record does not report an objective response estimate or its confidence interval, so neither the observed response frequency nor its precision can be evaluated from the record.
The enrollment of 17 describes the number entered in the trial record, not necessarily the number included in every endpoint analysis. Analysis populations and the number assessed for the primary endpoint are not reported in the registry record. In general, missing outcome data can affect an estimate if participants with unavailable assessments differ from those with observed assessments. The record does not describe missing-data methods or the extent of missing outcome data.
What can planning illustrations tell readers?
Sample-size calculations are planning tools, not observed results. General planning calculations describe how many participants might be needed under stated assumptions about the effect to detect, significance level, allocation, and statistical method. The registry record does not report the trial's own sample-size justification or its design assumptions, so a planning illustration should not be read as evidence of the trial's original design or of achieved power.
Any sample-size illustration based on an observed effect is conditional on that effect and the assumptions used for the illustration. It does not show that the trial had a particular probability of detecting an effect after the study was completed. Sample sizes are planning illustrations, never observed power. The record does not give a primary response effect estimate, so the reader should not infer a response-based planning target from the enrollment alone.
More generally, statistical significance and clinical importance are not interchangeable. A statistical test addresses compatibility of data with a specified statistical model or null hypothesis; it does not establish that an effect is important to patients or that a treatment caused an outcome. The registry record reports no primary endpoint analysis or p-value, and the single-group design does not supply a randomized treatment contrast.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists objective response as the primary outcome and names overall survival, duration of response, progression-free survival, and change in cellular immune parameters among the secondary outcomes. The record identifies 5 outcome measures, but does not provide the full analysis plan or explain how outcomes were prioritized beyond naming the primary endpoint.
When several outcomes or statistical tests are examined, general statistical practice considers multiplicity: repeated testing can increase the chance of at least one apparently positive result by chance. Possible approaches include prespecifying a primary analysis or adjusting interpretation for multiple tests. The registry record does not report whether any multiplicity procedure was planned or used. It also reports no posted analyses.
The primary response result and numerical secondary outcome results are not reported in the registry record. The record does not state how missing measurements were handled, whether outcomes were analyzed for all enrolled participants or a defined subset, or how many participants contributed to each analysis. Those analysis populations and missing-data methods are therefore not reported in the registry record.
These omissions limit assessment of whether results were analyzed as planned, how much data were available, and how uncertainty or multiple outcomes were handled. They do not establish that a method was or was not used; they mean that the relevant details are not reported in the registry record.
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 |
|---|---|---|---|
| Celecoxib and Recombinant Interferon Alpha-2b | 2 | 17 | 11.8% |
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 |
|---|---|
| Celecoxib and Recombinant Interferon Alpha-2b | 17 of 17 |
Most frequent serious adverse event terms
| Event term | Organ system | Celecoxib and Recombinant Interferon Alpha-2b |
|---|---|---|
| Seizures | Nervous system disorders | 1 of 17 |
| Thrombosis/embolism | Cardiac disorders | 1 of 17 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Celecoxib and Recombinant Interferon Alpha-2b |
|---|---|---|
| Fatigue | General disorders | 14 of 17 |
| Anorexia | Metabolism and nutrition disorders | 9 of 17 |
| Nausea | Gastrointestinal disorders | 9 of 17 |
| Lymphopenia | Blood and lymphatic system disorders | 8 of 17 |
| Diarrhea | Gastrointestinal disorders | 7 of 17 |
| Platelets | Blood and lymphatic system disorders | 7 of 17 |
| Hemoglobin | Blood and lymphatic system disorders | 6 of 17 |
| Leukocytes | Blood and lymphatic system disorders | 6 of 17 |
| Prutitus | Skin and subcutaneous tissue disorders | 6 of 17 |
| Hypocalcemia | Metabolism and nutrition disorders | 5 of 17 |
Serious events with the highest arm-level rate: seizures (5.9%), thrombosis/embolism (5.9%).
The adverse event record lists one group titled Celecoxib and Recombinant Interferon Alpha-2b, with 17 participants at risk for serious adverse events and 2 affected. For other adverse events, 17 participants were at risk and 17 were affected. These are participant counts in the registry record; they are not counts of the total number of separate event episodes.
The leading serious adverse event terms are seizures and thrombosis/embolism, each reported at 5.9%. The record does not provide further event-level detail, such as timing, severity grades, duration, recurrence, or the number of participants affected by each term beyond the listed rates. Death counts are not reported in the registry record.
Serious adverse events and other adverse events are distinct categories in this record. The reported counts do not establish that an event was caused by treatment: attribution to treatment is not reported in the registry record. The record also does not describe the event-collection period or the criteria used for each category. These safety figures should therefore be read as recorded counts for the listed group, not as a causal comparison or a complete account of safety over time.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a phase II, single-group trial evaluated celecoxib plus recombinant interferon alfa-2b in metastatic renal cell carcinoma with 3+ COX-2 tumor immunostaining. It specifies a RECIST-based objective response endpoint and a schedule for assessment. It also records serious and other adverse event counts for the treatment group.
However, the record does not report the primary response result. It therefore cannot show how many participants met objective response criteria, what response rate was observed, or how precisely that rate was estimated. The listed secondary outcomes also have no numerical results in the registry record. Descriptions of the intervention and measurement plan should not be mistaken for evidence about the size or direction of outcomes.
Even if within-group outcomes were available, the design would not provide a randomized comparison with another treatment. General causal interpretation requires care because outcomes in a single treated group do not reveal the counterfactual outcomes those same participants would have experienced under a different condition. The design therefore does not establish a comparative treatment effect.
The safety counts provide descriptive information for the group, including 2 participants with a serious adverse event and 17 with an other adverse event. They do not establish treatment causation, and the registry record does not report event attribution or detailed follow-up information. The most defensible interpretation is limited to the design, endpoint definitions, and event counts actually recorded; the primary clinical outcome and its uncertainty remain unreported.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a carefully defined endpoint and a reported result. The registry specifies objective response by RECIST criteria, describes the response assessment schedule, and explains how best overall response is assigned. Yet it does not report the response count or an estimate of response frequency. Without those results, readers cannot assess the central endpoint's observed magnitude or precision.
The single-group design also makes the inferential boundary clear. Such a design can describe outcomes among participants receiving a combination, but it does not directly compare the combination with an alternative. Recognizing that distinction helps prevent a within-group observation from being interpreted as a causal treatment contrast.
The record also illustrates why outcome reporting and analysis details matter. It lists several secondary outcomes and gives adverse event counts, but does not report the numerical secondary results, analysis populations, missing-data methods, or multiplicity approach. Those details help readers understand which participants contributed to results and how uncertainty across several outcomes was considered.
These features matter to biostatisticians and clinical researchers because transparent reporting connects the protocol's question, the analysis, and the claims readers can support. In this record, the trial's design and measurement plans are described more fully than its efficacy results. That gap constrains interpretation without changing the registry entries that the registry does report.
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 primary limitation for interpreting the central clinical question is that the objective response result is not reported in the registry record. The record gives the endpoint definition and schedule but not the response count, rate, confidence interval, or number assessed. The secondary outcomes are listed without numerical results.
The trial is single group, with no separate comparator, allocation listed as NA, and masking listed as none. As a result, the design does not provide a randomized estimate of a treatment difference. The registry record does not report detailed eligibility criteria, the protocol, a sample-size justification, or the statistical analysis plan.
Analysis populations, participant flow, missing-data methods, and the handling of multiple outcomes are not reported in the registry record. It is therefore not possible to determine from the record how many participants contributed to each endpoint or how unavailable measurements were handled. The duration and completeness of follow-up for the listed outcomes are also not reported.
For safety, the record gives participant counts and leading serious adverse event terms, but does not report attribution to treatment, event timing, detailed severity information, or event-collection procedures. Death counts are not reported. These limitations mean the safety figures should be interpreted descriptively rather than as a complete, causal comparison.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Celecoxib and Recombinant Interferon Alfa-2b in Metastatic Kidney Cancer Who Have Undergone Surgery — NCT01158534.
- Registry record last updated 2012-08-07; status last verified 2012-08.
- Results first posted 2012-07-12.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
The registry record describes a completed phase II, single-group trial sponsored by Case Comprehensive Cancer Center. It lists enrollment of 17 and evaluates oral celecoxib with subcutaneous recombinant interferon alfa-2b in metastatic renal cell carcinoma with 3+ COX-2 tumor immunostaining. The treatment courses repeat every 28 days in the absence of progression or unacceptable toxicity.
The primary endpoint is objective response assessed by RECIST criteria, with assessment at week 4 of cycle 2 and every other cycle thereafter. The primary response result and numerical secondary outcome results are not reported in the registry record. Safety entries list 2 participants with a serious adverse event and 17 with an other adverse event. The record does not report a comparator group, analysis populations, missing-data methods, or treatment attribution for adverse events.