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 Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC) (NCT00267748), a randomized phase 2 study. The primary outcome is Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00267748 |
| Phase | Phase 2 |
| Condition | Carcinoma, Renal Cell |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 317 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
The central question is whether time to tumor progression differs between two sunitinib malate dosing schedules used as first-line therapy for metastatic renal cell cancer. The 4/2 schedule consists of 4 weeks on treatment followed by 2 weeks off treatment; the comparator is continuous daily dosing. The registry describes the trial as randomized, with parallel groups and no masking.
The record also describes a trial with two parts. The first part concerned determining doses of sunitinib malate and interferon alfa-2b that could be given safely in combination, and is described as closed to enrollment. The second part was intended to compare the 4/2 and continuous schedules for delaying progression and to assess response, survival, side effects, symptoms, and possible predictive tests. The primary endpoint is time to tumor progression, assessed using the Memorial Sloan-Kettering Cancer Center prognostic factors model.
The posted record reports enrollment of 317 participants and identifies an intent-to-treat population consisting of everyone randomized, whether or not they received study medication. It does not report the primary endpoint medians, confidence intervals, or sponsor-reported hazard-ratio estimates. Thus, the registry description establishes the question and design, but does not by itself give the numerical result needed to characterize the size or precision of the schedule comparison.
Population
People with metastatic renal cell cancer receiving first-line therapy. The primary endpoint description defines the intent-to-treat population as all randomized participants, regardless of whether they received study medication.
Intervention
Sunitinib malate on a 4/2 schedule: 4 weeks on treatment and 2 weeks off treatment.
Comparator
Sunitinib malate given by continuous daily dosing.
Primary question
How does time to tumor progression compare between the two dosing schedules, with endpoint assessment using the MSKCC prognostic factors model?
3. Trial Design
The registry identifies NCT00267748 as a completed randomized Phase II study of sunitinib malate schedule 4/2 versus continuous dosing as first-line therapy for metastatic renal cell cancer. The reported enrollment is 317. The trial is described as having a parallel-group model and no masking. Random allocation can help balance measured and unmeasured participant characteristics between groups on average; lack of masking means treatment assignment was not concealed from participants and trial personnel in the way it would be in a masked trial.
The record's brief summary describes two parts. The first part examined doses of sunitinib malate and interferon alfa-2b for combination use and is described as closed to enrollment. The second part was designed to compare the 4/2 schedule with continuous dosing. The listed interventions for the study are sunitinib malate continuous daily dosing and sunitinib malate schedule 4/2. The adverse-event record also lists a group receiving sunitinib 37.5 mg with interferon alfa-2b, in addition to groups receiving sunitinib 50 mg on schedule 4/2 and sunitinib 37.5 mg.
The primary endpoint is time to tumor progression, with a median and 95% confidence interval specified as the outcome measure. The primary endpoint timeframe is described as beginning at randomization and continuing until documented progression or death due to any cause, assessed up to a maximum of 2 years. The endpoint description also gives a calculation based on the first dose of study medication and describes death due to cancer. These differences in wording should be kept in mind when interpreting the endpoint definition.
The record lists secondary outcomes for objective response, duration of response, and overall survival assessed using the MSKCC prognostic factors model. It reports 6 outcome measures and 12 analyses, but detailed statistical methods beyond the posted endpoint descriptions are not reported in the registry record. In particular, the protocol, the rationale for the planned enrollment, interim analyses, and a full statistical analysis plan are not 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.
Non-randomized Period
| Stage | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|---|
| STARTED | 25 | 0 | 0 |
| COMPLETED | 2 | 0 | 0 |
| NOT COMPLETED | 23 | 0 | 0 |
Reasons for not completing this period:
| Reason | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|---|
| Progressive disease | 10 | 0 | 0 |
| Adverse Event | 8 | 0 | 0 |
| Death | 1 | 0 | 0 |
| Participant not willing to participate | 1 | 0 | 0 |
| Other | 3 | 0 | 0 |
Randomized Period
| Stage | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|---|
| STARTED | 0 | 146 | 146 |
| Treated | 0 | 146 | 143 |
| COMPLETED | 0 | 19 | 14 |
| NOT COMPLETED | 0 | 127 | 132 |
Reasons for not completing this period:
| Reason | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|---|
| Death | 0 | 2 | 3 |
| Adverse Event | 0 | 23 | 25 |
| Global deterioration of health status | 0 | 6 | 7 |
| Lost to Follow-up | 0 | 1 | 0 |
| Objective progression or relapse | 0 | 77 | 86 |
| Withdrawal by Subject | 0 | 9 | 2 |
| Other | 0 | 9 | 6 |
| randomized but not treated | 0 | 0 | 3 |
Analysis population for the primary outcome, as defined in the registry: The intent-to-treat (ITT) population included all participants who were randomized into the study regardless of whether they received study medication.
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 | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 25 | 146 | 146 | 317 | |
| Age Continuous | Years | 62.4 (SD 7.2) | 60.4 (SD 9.8) | 64.3 (SD 9.7) | 62.4 (SD 9.7) |
| Sex: Female, Male: Female | Participants | 5 | 45 | 57 | 107 |
| Sex: Female, Male: Male | Participants | 20 | 101 | 89 | 210 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model, measured over From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is time to tumor progression (TTP), reported as a median with a 95% confidence interval. A time-to-event endpoint records how long it takes for a defined event to occur. In this trial, the registry's primary timeframe says that follow-up starts at randomization and ends at documented progression or death due to any cause, with assessment up to a maximum of 2 years.
The endpoint description also defines TTP as time from the start of study treatment to the first documentation of objective tumor progression or death due to cancer. It states that TTP was calculated from the first event date and the first dose date, with an adjustment of one day, then divided by 30.44. The difference between the timeframe wording and the endpoint description matters: one refers to death due to any cause, while the other refers to death due to cancer. The registry record does not clarify this difference.
The endpoint is assessed using the MSKCC prognostic factors model, which classifies participants as low, intermediate, or high risk based on the number of prognostic criteria present. Prognostic categories can be used to describe baseline risk and to examine outcomes in groups with different prognoses. The registry record does not report the number of participants in each category or the primary endpoint results by category.
General: a median time-to-event value describes the point by which half of the relevant observed event-time distribution has occurred, subject to the analysis method and follow-up. A confidence interval communicates uncertainty around an estimate; it is not a guarantee that an individual participant's event will occur within that interval. The registry record specifies a median and 95% confidence interval but does not report their values for the primary comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes a randomized comparison of two sunitinib malate dosing schedules and identifies time to tumor progression as the primary endpoint. It does not report the numerical primary endpoint results. The median TTP values, their 95% confidence intervals, and sponsor-reported hazard-ratio estimates are not reported in the registry record. Without those estimates, it is not possible to describe the observed direction, magnitude, or precision of the primary comparison from this record.
Enrollment was 317, but enrollment alone does not show how many participants experienced progression or death, how long they were followed, or how outcomes differed between treatment schedules. The record's primary endpoint timeframe is assessment up to a maximum of 2 years; that ceiling is not itself a statement that every participant was followed for that duration. Numbers of events, censoring information, and details of follow-up are not reported in the registry record.
The registry describes the study as randomized, parallel-group, and unmasked. Random allocation supports a comparative interpretation by helping make treatment groups comparable at baseline on average. It does not remove uncertainty in the estimated treatment contrast. Because the study was unmasked, assessments or decisions that involve judgment could potentially be influenced by knowledge of assigned treatment; the record does not describe procedures used to address that possibility.
The listed secondary outcomes include objective response, duration of response, and overall survival. Their numerical results are not reported in the registry record. The brief summary also names symptoms and possible predictive tests among the trial's aims, but the record does not give results for those aims. No conclusion about the clinical benefit or lack of benefit of either schedule should be drawn from the study description alone.
General: a hazard ratio is a relative comparison of event rates over follow-up, under the assumptions of the analysis. A median and a hazard ratio answer related but distinct questions: the median describes a point in the event-time distribution, while the hazard ratio compares event rates over time. Neither measure, without its estimate and uncertainty, can establish how large or precise a comparison is. The posted registry entries describe the analysis type but do not include numerical results for these comparisons.
The record states that 6 outcome measures and 12 analyses are present. Multiple outcomes or analyses can make results harder to interpret if the analysis plan and approach to multiplicity are not clear. The plan for handling multiple comparisons is not reported in the registry record. Any illustrative planning estimates associated with the posted results are planning illustrations, not observed power and not a substitute for the trial's outcome estimates.
9. Statistical Methods Explained
General statistical concepts help clarify what the listed methods would mean, but they do not fill gaps in the registry record. The record identifies a median time-to-event endpoint and specifies a 95% confidence interval. It also indicates that the intended interpretation of the primary outcome is time to tumor progression and that sponsor-reported hazard ratios are the relevant effect measure for time-to-event results. Numerical estimates are not reported in the registry record.
What does a median time-to-event estimate describe?
General: time-to-event analyses use both the timing of events and information from participants who have not had an event by the end of their observed follow-up. A participant without a recorded event may be censored, meaning that the exact event time is unknown but the participant contributed information up to a known point. This approach is useful when follow-up times vary or when some participants have not experienced the event during observation. The registry record does not report the number of events, the extent of censoring, or the censoring rules used in the analysis.
A median summarizes the event-time distribution by identifying the point at which half of the estimated distribution has experienced the event. It does not describe the experience of every participant, and it does not alone show whether the treatment groups differ throughout follow-up. The registry specifies a median and a 95% confidence interval for TTP, but the estimates themselves are not reported in the registry record.
What does a hazard ratio add?
General: a hazard ratio compares the instantaneous event rates between groups over time, conditional on remaining event-free until each time. Its interpretation depends on the analysis and, for a single summary ratio, on whether the relative event rates are reasonably represented by a constant relationship over follow-up. A hazard ratio is not a direct difference in median times and should not be read as a probability that a participant will experience an event. The registry's statistical summary indicates use of sponsor-reported hazard ratios, but their values and confidence intervals are not reported in the registry record.
A confidence interval conveys the uncertainty associated with an estimate under the statistical model. Wider intervals generally indicate less precision, while narrower intervals indicate greater precision. A confidence interval does not express the range of possible outcomes for an individual participant. In this record, the primary endpoint is specified with a 95% confidence interval, but the interval limits are not reported in the registry record. No p-value for the primary comparison is reported in the registry record.
Why is the intent-to-treat population important?
The primary endpoint description defines the intent-to-treat population as everyone randomized, regardless of whether study medication was received. General: analyzing participants according to their randomized assignment preserves the comparison created by randomization and reflects the effect of assignment to a treatment strategy, rather than only the experience of participants who completed or adhered to treatment. This does not mean that missing outcome data cease to matter. The registry record does not describe how missing outcome information, withdrawals, or other departures from follow-up were handled.
The record describes random allocation, a parallel-group design, and no masking. General: randomization is intended to reduce systematic differences between groups at the start of a trial. Parallel groups allow treatment strategies to be compared over the same study period. Masking can reduce the influence of treatment knowledge on behavior, co-interventions, outcome reporting, or assessment; because masking is listed as none, the registry does not claim those protections. The record does not describe additional safeguards for outcome assessment.
How should planning illustrations be read?
The planning assumptions describe an illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For a time-to-event illustration, the total number of events is the relevant planning quantity; other illustrations are expressed as participants per arm. The assumed effect is stated as a fraction of the observed effect. General: such calculations explore what a future design might require under specified assumptions. They are not the trial's observed power, do not show that the trial was adequately powered, and do not replace the observed outcome estimates. The registry record does not report the original sample-size justification or the numerical planning outputs.
General: over-dispersion is variation in count data greater than expected under a simple model such as a Poisson model. Accounting for it can prevent uncertainty from being understated when observations are more variable than that model assumes. The registry record does not describe a count outcome analysis or report an over-dispersion adjustment, so this concept should not be taken as a claim about the methods used in this trial.
The registry record identifies 6 outcome measures and 12 analyses. A complete assessment of the statistical methods would require details such as the analysis populations for each outcome, treatment of missing observations, covariate adjustment, censoring rules, and handling of multiple comparisons. Those details are not reported in the registry record. General: prespecified methods make it easier to distinguish confirmatory analyses from exploratory ones and to interpret estimates in the context of the full set of analyses.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 6 outcome measures and 12 analyses. The primary endpoint is TTP; listed secondary outcomes include objective response, duration of response, and overall survival assessed using the MSKCC prognostic factors model. The brief summary also describes aims concerning symptoms and possible predictive tests. When a trial considers several outcomes or analyses, the chance of at least one apparently notable result can increase if each is interpreted without accounting for the full set. General: multiplicity methods can address this issue by controlling the overall error rate or by specifying a hierarchy of outcomes. The trial's approach to multiplicity is not reported in the registry record.
The primary endpoint description defines the intent-to-treat population as all randomized participants, regardless of whether they received study medication. That definition is useful because it clarifies who belongs in the primary analysis population. However, the registry record does not describe the amount or pattern of missing outcome data, how withdrawals were handled, or whether sensitivity analyses were used to assess the effect of missing information. The method used to handle censoring in the time-to-event analysis is not reported in the registry record.
The registry wording for TTP is not fully consistent. The primary timeframe refers to progression or death due to any cause, while the endpoint description defines the event as objective progression or death due to cancer. The endpoint description also refers to time from the first dose, whereas the timeframe begins at randomization. The registry record does not explain these differences, so the exact operational definition should be interpreted cautiously.
The protocol, complete statistical analysis plan, sample-size justification, and any interim analyses are not reported in the registry record. General: these details help readers determine which analyses were planned in advance and how departures from the original plan were addressed. Their absence from the registry record does not establish that no plan or procedure existed; it means those details cannot be evaluated from this 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 |
|---|---|---|---|
| Sunitinib 37.5 mg + Interferon Alpha-2b | 7 | 25 | 28.0% |
| Sunitinib 50 mg (Schedule 4/2) | 50 | 146 | 34.2% |
| Sunitinib 37.5 mg | 54 | 143 | 37.8% |
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 |
|---|---|
| Sunitinib 37.5 mg + Interferon Alpha-2b | 25 of 25 |
| Sunitinib 50 mg (Schedule 4/2) | 144 of 146 |
| Sunitinib 37.5 mg | 142 of 143 |
Most frequent serious adverse event terms
| Event term | Organ system | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | 1 of 25 | 6 of 146 | 12 of 143 |
| Disease progression | General disorders | 0 of 25 | 7 of 146 | 11 of 143 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 1 of 25 | 3 of 146 | 3 of 143 |
| Anaemia | Blood and lymphatic system disorders | 1 of 25 | 3 of 146 | 2 of 143 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 1 of 25 | 2 of 146 | 3 of 143 |
| Vomiting | Gastrointestinal disorders | 0 of 25 | 3 of 146 | 3 of 143 |
| Pneumonia | Infections and infestations | 0 of 25 | 3 of 146 | 3 of 143 |
| Hyponatraemia | Metabolism and nutrition disorders | 0 of 25 | 1 of 146 | 5 of 143 |
| Renal failure acute | Renal and urinary disorders | 0 of 25 | 2 of 146 | 4 of 143 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 0 of 25 | 2 of 146 | 4 of 143 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|---|---|
| Fatigue | General disorders | 25 of 25 | 94 of 146 | 100 of 143 |
| Diarrhoea | Gastrointestinal disorders | 20 of 25 | 85 of 146 | 98 of 143 |
| Nausea | Gastrointestinal disorders | 14 of 25 | 91 of 146 | 76 of 143 |
| Decreased appetite | Metabolism and nutrition disorders | 11 of 25 | 46 of 146 | 59 of 143 |
| Dysgeusia | Nervous system disorders | 7 of 25 | 55 of 146 | 49 of 143 |
| Vomiting | Gastrointestinal disorders | 8 of 25 | 48 of 146 | 48 of 143 |
| Hypertension | Vascular disorders | 6 of 25 | 46 of 146 | 42 of 143 |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 6 of 25 | 46 of 146 | 36 of 143 |
| Rash | Skin and subcutaneous tissue disorders | 6 of 25 | 36 of 146 | 44 of 143 |
| Constipation | Gastrointestinal disorders | 5 of 25 | 40 of 146 | 39 of 143 |
Serious events with the highest arm-level rate: dehydration (8.4%), disease progression (7.7%), anaemia (4.0%), myocardial infarction (4.0%), gastrointestinal haemorrhage (4.0%).
The adverse-event record lists three groups: sunitinib 37.5 mg with interferon alfa-2b, sunitinib 50 mg on schedule 4/2, and sunitinib 37.5 mg. For serious adverse events, the record lists 7 affected participants among 25 at risk in the combination group, 50 among 146 in the schedule 4/2 group, and 54 among 143 in the sunitinib 37.5 mg group. The corresponding groups for other adverse events list 25 of 25, 144 of 146, and 142 of 143 affected. These are counts as recorded, not adjusted comparisons between randomized schedules.
The most frequently listed serious terms include dehydration at 8.4%, disease progression at 7.7%, anaemia at 4.0%, myocardial infarction at 4.0%, gastrointestinal haemorrhage at 4.0%, and cholecystitis at 4.0%. These term-specific percentages should be read as the registry reports them. They do not indicate how severe or persistent an event was for an individual, and a participant may contribute to more than one event category.
The record includes a deaths field for the groups, but deaths are not reported in the registry record. Group sizes and event counts do not by themselves establish that one schedule has a higher or lower safety risk. The listed groups include different dosing descriptions, including a combination group, so they should not be treated as a direct two-arm comparison of the primary schedule question without additional analysis details.
12. What the Result Does, and Does Not, Mean
The trial description sets out a randomized comparison of schedule 4/2 with continuous daily dosing for first-line treatment of metastatic renal cell cancer. It identifies TTP as the primary endpoint and provides an intent-to-treat definition. These details make the study question and the intended population understandable. The record also gives enrollment, design features, and some adverse-event counts.
However, the primary endpoint's median estimates, confidence intervals, and sponsor-reported hazard ratios are not reported in the registry record. Numerical results for the listed secondary outcomes are also not reported in the registry record. As a result, the posted record does not establish the size or precision of the comparative effect on TTP, nor does it allow a statistical assessment of the response, duration-of-response, or overall-survival findings.
General: a trial result is best interpreted using the estimated effect and its uncertainty, alongside the design, analysis population, follow-up, and outcome definition. A result can be imprecise even when a study is randomized, and an estimate can be difficult to interpret if methods or endpoint definitions are unclear. Here, the registry's difference in TTP wording—death due to any cause in the timeframe, versus death due to cancer in the endpoint description—adds uncertainty about the exact event definition.
The adverse-event counts and listed terms describe reported safety information for the groups recorded in the registry. They are not sufficient, by themselves, to make a comparative safety conclusion about the two schedules. The groups include a combination-treatment group and the record does not provide a complete comparative analysis of the listed adverse events.
The trial's design and registry description therefore support a clear account of what was intended to be compared, but not a conclusion about which schedule had better or worse outcomes. No treatment recommendation follows from the registry description alone. The key numerical outcome estimates and important analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why a well-defined design question and a complete set of numerical results are both needed for statistical interpretation. Randomization and a parallel-group model define the intended comparison between the 4/2 and continuous dosing schedules. The intent-to-treat definition identifies the population for the primary endpoint. These elements help readers understand the comparison being attempted.
The endpoint is time-to-event, so interpretation depends not only on the number of participants enrolled but also on event timing, follow-up, censoring, and the definition of an event. The primary timeframe and endpoint description differ on whether death from any cause or death due to cancer is included, and on whether timing begins at randomization or first dose. Clarifying those details is important because a change in the event definition or time origin can affect what an estimate represents.
The record also demonstrates that a trial can list multiple outcomes and analyses. With 6 outcome measures and 12 analyses, readers need to know which comparisons were primary, which were secondary or exploratory, and how multiplicity was addressed. Those methods are not reported in the registry record. Similarly, the absence of a reported sample-size justification makes it impossible to evaluate the original planning rationale from this record.
Finally, design details do not substitute for results. Without the primary medians, confidence intervals, or hazard-ratio estimates, the comparative effect and its precision cannot be evaluated. For biostatisticians and clinical researchers, this distinction is central: a registry description can define the intended estimand and document selected design features, while still leaving the empirical evidence needed to interpret the trial unavailable in the record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important limitation for interpreting this registry entry is that numerical results for the primary endpoint are not reported in the registry record. The median TTP estimates, 95% confidence intervals, and sponsor-reported hazard ratios are absent, as are numerical results for the listed secondary outcomes. This prevents assessment of the magnitude, direction, and precision of the intended schedule comparison from the registry record.
The endpoint description is not fully consistent about the time origin and death definition. The timeframe begins at randomization and includes death due to any cause, while the endpoint description refers to time from first dose and death due to cancer. The record does not explain which wording governed the analysis. This is a limitation in interpreting exactly what the primary endpoint represents.
The trial is described as unmasked. The record does not describe measures used to reduce potential influence of treatment knowledge on outcome assessment or reporting. The registry also describes two trial parts and includes adverse-event groups that do not all correspond to the two schedule labels in the central comparison. The record does not give enough analysis detail to establish how those groups relate to each outcome analysis.
Important methodological details—including missing-data handling, censoring rules, multiplicity procedures, the original sample-size justification, interim analyses, and the full statistical analysis plan—are not reported in the registry record. The adverse-event record lists deaths as null; deaths are not reported in the registry record. These gaps limit both efficacy and safety interpretation. They do not show that the trial lacked methods or analyses; they limit what can be concluded from this registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC) — NCT00267748.
- Registry record last updated 2011-09-05; status last verified 2011-08.
- Results first posted 2011-09-05.
- 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
NCT00267748 is a completed randomized Phase II study with enrollment of 317. It compares sunitinib malate schedule 4/2 with continuous daily dosing as first-line therapy for metastatic renal cell cancer. The record describes a parallel-group design with no masking and a two-part trial, including an initial combination-dose part and a schedule-comparison part.
The primary endpoint is median time to tumor progression, with a 95% confidence interval and assessment using the MSKCC prognostic factors model. The primary endpoint description defines the intent-to-treat population as all randomized participants, whether or not they received study medication. The record lists 6 outcome measures and 12 analyses.
Primary and secondary numerical outcome estimates are not reported in the registry record. The record also does not report the full statistical analysis plan, missing-data methods, or multiplicity procedures. It lists adverse-event counts and serious-event terms for three groups, but those figures do not constitute a complete comparative safety analysis.