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 and Capecitabine for First Line Colon Cancer (NCT00961571), a na phase 2 study. The primary outcome is Progression-free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00961571 |
| Phase | Phase 2 |
| Condition | Metastatic Colorectal 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 | Georgetown University |
| Results posted | Yes |
2. Clinical Question
Population
Patients with metastatic colorectal cancer who had not received chemotherapy for their cancer. The registry lists an enrollment of 50, although it does not clarify in the outcome information how many participants contributed to the primary endpoint or safety results.
Intervention
Sunitinib and capecitabine, administered by mouth every day until the cancer worsened, according to the study summary. The listed intervention is a combination of these medicines.
Comparator
There is no separate comparator arm. The registry identifies the study as a single-group trial, with allocation marked NA and no masking. Therefore, the design does not provide a randomized, like-for-like control comparison.
Primary question
The study set out to assess progression-free survival during treatment with sunitinib and capecitabine. The primary endpoint defines progression-free survival as the months from enrollment to progression or death, with a timeframe of 36 months. The registry does not report the observed median, its full range, or an estimated treatment effect. The stated purpose was to find out whether the medicines could be used together to improve progression-free survival; the posted information does not establish a comparative effect because it has no control arm and no primary outcome result.
3. Trial Design
This is a single-center, Phase II trial sponsored by Georgetown University. The registry lists metastatic colorectal cancer as the condition and describes a first-line treatment study among patients who had not received chemotherapy for their cancer. The intervention is sunitinib and capecitabine, described as oral medicines taken every day until the cancer worsened. The registry identifies one group and no masking; allocation is listed as NA. There is no randomized comparator group in the recorded design.
The registry lists enrollment as 50. It records a start date of 2009-08, a primary completion date of 2011-03, and a status of terminated. The reason for termination, whether enrollment reached the listed number, and the number included in the primary endpoint analysis are not reported in the registry record. The listed primary outcome is progression-free survival, measured in months from enrollment to progression or death, with a 36 months timeframe. The outcome is specified as a median with full range, but no median or range is posted.
A single-group design can describe outcomes among participants receiving the combination, but it cannot directly distinguish treatment effects from other explanations, such as the underlying course of illness or participant selection. General statistical context: random allocation to a concurrent control group is one way trials support a comparative interpretation by balancing factors that may affect outcomes. This design has no such comparison. The registry record does not report a protocol, details of the enrollment target, or the reason the trial 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.
Overall Study
| Stage | Sunitinib and Cepecitabine |
|---|---|
| STARTED | 50 |
| COMPLETED | 11 |
| NOT COMPLETED | 39 |
Reasons for not completing this period:
| Reason | Sunitinib and Cepecitabine |
|---|---|
| Physician Decision | 39 |
Analysis population for the primary outcome, as defined in the registry: Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.
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: metastatic colon cancer who has not received 1st line systemic chemotherapy
| Characteristic | Unit | Sunitinib and Cepecitabine |
|---|---|---|
| Participants analysed | 11 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 |
| Age, Categorical: >=65 years | Participants | 6 |
| Age, Continuous | years | 67 (23 to 88) |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 6 |
| Region of Enrollment: United States | participants | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival, measured over 36 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is progression-free survival (PFS). The registry defines it as the number of months between each participant’s enrollment and the date of progression or death. Its stated timeframe is 36 months, and the planned summary is a median with full range. The registry record does not post an observed median, range, or other estimate for this endpoint.
In general, a time-to-event endpoint uses the time until a defined event rather than simply whether the event occurred. PFS combines progression and death in one endpoint; the registry’s definition does not provide separate estimates for those two event types. A median summarizes the time at which half the observed time-to-event distribution has reached the event, subject to the analysis method and available follow-up. A range describes the span of observed values, but neither summary is available in the posted results.
PFS is used in clinical trials to characterize how long participants remain alive without documented progression. It is not the same as overall survival, because progression can occur before death and the endpoint counts either event. The registry does not provide the assessment rules for progression, follow-up procedures, or handling of participants whose event status was not observed. Those details matter for interpreting a time-to-event estimate, so the endpoint definition alone is not enough to reconstruct an analysis or assess its precision.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a Phase II, single-group study of sunitinib and capecitabine for first-line treatment of metastatic colorectal cancer. Its primary outcome is progression-free survival, defined from enrollment to progression or death. The record does not include a numerical PFS result. In particular, it does not report the specified median or full range, nor a confidence interval, hazard ratio, or test result. There is therefore no posted primary endpoint estimate from which to assess the observed duration or its statistical precision.
The record lists one outcome measure and zero analysis records. That absence does not establish that no analysis was conducted; it means a statistical analysis is not reported in the registry record. There is also no sponsor-reported hazard ratio in the information recorded for this trial. As a result, no comparative treatment effect can be described from the posted results.
The absence of a control arm is central to interpretation. An outcome observed in a single group cannot by itself show what would have happened to comparable participants under another treatment or without this combination. General statistical context: a randomized concurrent comparison can estimate a difference between assigned groups under the trial’s assumptions. Here, there is no such group, so even a reported time-to-event estimate would describe the study group rather than isolate the effect of the combination.
The registry lists enrollment as 50, while the adverse-event group lists 11 participants at risk. The record does not explain the relation between these entries, how many participants received treatment, or how many contributed to the primary endpoint. The status is terminated, but a reason is not reported. These omissions limit interpretation of both the completeness of follow-up and the safety counts.
The safety record lists 8 participants affected by serious events, 11 affected by other events, and 1 death in the group for which 11 were at risk. It also lists several serious-event terms with percentages. These are safety descriptions, not evidence of a comparative risk, since no control group is recorded. The record does not provide details sufficient to determine event attribution, timing, or whether the death was related to treatment.
Planning illustrations associated with the results should not be read as observed trial findings or as evidence of power achieved in this study. The stated sample-size assumptions describe hypothetical planning based on an observed effect, equal allocation, a two-sided significance level of 0.05, and a normal approximation. The registry does not report a trial-specific sample-size justification or a comparative observed effect in the information available. Overall, the record documents the trial question and some safety counts, but it does not report the primary efficacy result needed to characterize PFS in the treated group.
9. Statistical Methods Explained
The registry identifies progression-free survival as the primary endpoint and specifies a median with full range as the summary. It defines the event time as months from enrollment to progression or death and gives a 36 months timeframe. It does not report a median, full range, confidence interval, hazard ratio, or analysis result. The statistical interpretation must therefore distinguish the endpoint that was registered from an outcome estimate that is not posted.
What does a time-to-event endpoint represent?
In general, time-to-event methods describe how long it takes for an event to occur. They can use information from participants whose events are not observed during their available follow-up, rather than treating those participants as if they had an event at the end of observation. Such methods rely on rules for defining event dates, follow-up, and censoring. The registry record does not report those rules for this trial, nor does it state how progression was assessed or how participants with incomplete follow-up were handled.
For PFS in this trial, the event is the first recorded progression or death under the registry’s definition. The endpoint therefore combines two event types. General statistical context: combining events can give a useful summary of time without progression or death, but it does not tell the reader how much of the observed endpoint experience came from progression versus death unless those components are also reported. Separate component results are not reported in the registry record.
What does a median and full range communicate?
In general, the median is the central point of a distribution: half the observed times are on either side, subject to the way a time-to-event distribution is estimated. The full range gives the lowest and highest observed values. A median and range provide a compact description, but they do not show the entire distribution or, by themselves, quantify uncertainty around the median. A confidence interval serves a different purpose: in general, it communicates uncertainty in an estimate under a specified statistical procedure. No confidence interval for PFS is reported in the registry record.
Time-to-event analyses often use methods that account for participants whose event times are not fully observed. In general, censoring indicates that a participant’s event time is known only to extend beyond the last observed follow-up. The validity of estimates can depend on the follow-up pattern and assumptions about censoring. It is not reported in the registry record whether censoring occurred, how it was defined, or which estimation method was used. No survival curve or detailed event-time results are reported.
Why does the single-group design matter?
The design has one group receiving sunitinib and capecitabine, with allocation listed as NA and masking as none. There is no concurrent control group. In general, an estimate from one group describes outcomes among those participants; it does not directly estimate the difference that would have occurred under a different treatment. Factors other than treatment can influence observed outcomes. Consequently, a single-group PFS estimate, even if posted, would not by itself quantify a causal treatment effect. In this record, even that descriptive estimate is absent.
Hazard ratios are comparisons of event rates over time between groups under a statistical model. General context: a hazard ratio needs a defined comparison and cannot be inferred from a median alone. No sponsor-reported hazard ratio appears in the registry record, and the recorded design does not identify a second arm. There is no comparative estimate to interpret. No proportional-hazards assumption or other model specification is reported.
How should planning calculations be read?
The stated planning assumptions describe illustrations using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a fraction of an observed effect. For time-to-event planning, the stated convention is a total number of events. These are planning assumptions, not a report of the trial’s own design rationale or an analysis of observed data. The registry does not report a trial-specific sample-size justification. Any planning figures should be understood as hypothetical illustrations and not as observed power; the recorded trial itself is single-group, not an equal-allocation, two-arm comparison.
In general, a significance level is a threshold specified for a statistical test, while power is a planning probability under assumed conditions. Neither describes the precision or reliability of an actual result without a suitable analysis and its assumptions. The registry record does not report a test, p-value, or treatment-effect estimate for the primary endpoint. The stated planning assumptions do not fill that gap.
The record lists an enrollment of 50 but does not report how many participants were analyzed for PFS or whether the listed enrollment was reached. There are zero analysis records. No method for missing data, analysis population, interim analysis, or adjustment for multiple testing is reported in the registry record. These are distinct elements of a statistical plan; none can be reconstructed from the endpoint definition or the planning assumptions alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, progression-free survival, and zero analysis records. It does not report a multiplicity strategy, such as whether any additional outcomes or tests were prespecified for formal inference, or whether adjustment for multiple comparisons was planned. A single registered primary outcome does not establish that the full analysis plan contained no other tests. The statistical plan and any multiplicity procedures are not reported in the registry record.
Missing-data handling is also not reported. For a time-to-event endpoint, follow-up may end before progression or death is documented; general statistical methods can account for that situation through censoring, but the registry does not state whether or how censoring was used in this trial. It does not describe loss to follow-up, withdrawal, missing progression assessments, or sensitivity analyses. The number of participants contributing to the endpoint analysis is not reported.
The registry does not identify an intention-to-treat, per-protocol, safety, or other analysis population for the primary outcome. The enrollment entry is 50, while the safety group lists 11 at risk; the record does not explain the relationship between these numbers. The safety group’s denominator should not be assumed to be the PFS analysis population. No protocol deviations, exclusions, or analysis-set definitions are reported.
These omissions limit the ability to judge whether outcome ascertainment was complete, how participants with incomplete follow-up contributed to the analysis, and whether the reported analysis followed a prespecified plan. Since no primary result is posted, the effect of any such decisions on an estimate cannot be evaluated from 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 |
|---|---|---|---|
| Sunitinib and Cepecitabine | 8 | 11 | 72.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sunitinib and Cepecitabine | 1 of 11 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sunitinib and Cepecitabine | 11 of 11 |
Most frequent serious adverse event terms
| Event term | Organ system | Sunitinib and Cepecitabine |
|---|---|---|
| Hypoalbuminemia | Hepatobiliary disorders | 5 of 11 |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | 3 of 11 |
| GI Obstruction | Gastrointestinal disorders | 2 of 11 |
| Dermatology/Skin - Other | Skin and subcutaneous tissue disorders | 1 of 11 |
| Fatigue | General disorders | 1 of 11 |
| Febrile neutropenia | General disorders | 1 of 11 |
| Gastrointestinal - Other | Gastrointestinal disorders | 1 of 11 |
| Lymphopenia | Blood and lymphatic system disorders | 1 of 11 |
| Nausea | General disorders | 1 of 11 |
| Neuropathy | Nervous system disorders | 1 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sunitinib and Cepecitabine |
|---|---|---|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | 10 of 11 |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | 7 of 11 |
| Hemoglobin | Blood and lymphatic system disorders | 6 of 11 |
| Fatigue (asthenia, lethargy, malaise) | General disorders | 5 of 11 |
| Nausea | General disorders | 5 of 11 |
| Anorexia | Gastrointestinal disorders | 4 of 11 |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Hepatobiliary disorders | 4 of 11 |
| Platelets | Blood and lymphatic system disorders | 4 of 11 |
| Alkaline phosphatase | Gastrointestinal disorders | 3 of 11 |
| Constipation | Gastrointestinal disorders | 3 of 11 |
Serious events with the highest arm-level rate: hypoalbuminemia (45.5%), neutrophils/granulocytes (anc/agc) (27.3%), gi obstruction (18.2%), dermatology/skin - other (9.1%), fatigue (9.1%).
The registry lists one safety group, titled “Sunitinib and Cepecitabine,” with 11 participants at risk. It records 8 participants affected by serious events, 11 affected by other events, and 1 death. These counts describe the safety information entered for that group. The registry does not explain why the number at risk differs from the enrollment entry of 50, or whether these safety counts cover every participant enrolled or treated.
The listed serious-event terms and percentages are hypoalbuminemia, 45.5%; neutrophils/granulocytes (ANC/AGC), 27.3%; GI obstruction, 18.2%; dermatology/skin - other, 9.1%; fatigue, 9.1%; and febrile neutropenia, 9.1%. These are presented as registry terms and percentages. The record does not provide event counts for each term, timing, severity grading details, or attribution to study treatment. It also does not clarify whether participants could contribute to more than one term.
In general, safety counts describe events recorded in a study group and are not a comparative risk estimate. With no separate control group, these figures cannot establish whether the combination changed the likelihood of an event relative to another treatment. The single reported death is not accompanied by a cause or treatment-relatedness assessment in the registry record. The counts should therefore be read as descriptive registry entries, with the denominator and reporting context in mind.
12. What the Result Does, and Does Not, Mean
The record establishes that a single-center Phase II study was conducted to examine sunitinib and capecitabine in first-line metastatic colorectal cancer. The stated primary question concerned progression-free survival, defined as the time from enrollment to progression or death. The record also contains safety entries for one group. These details describe the study’s purpose and selected registry information; they do not provide a complete efficacy or safety assessment.
The primary PFS result is not reported in the registry record. No median or full range is posted, and there is no confidence interval, hazard ratio, or p-value. Thus, the observed time to progression or death and its precision cannot be characterized from the posted results. The status is terminated, but the reason for termination is not reported.
The study has no randomized comparator group. General statistical context: outcomes in a single group do not show what would have happened to similar participants under an alternative treatment. The design therefore cannot directly estimate a comparative effect. Even a numerical PFS summary, if available, would describe the group’s observed experience rather than provide a controlled estimate of treatment benefit.
The safety entries list participants affected by serious and other events and one death, along with serious-event terms and percentages. They do not identify a comparative safety difference, treatment attribution, or the cause of the death. The listed safety group has 11 participants at risk, whereas the registry enrollment entry is 50; the relation between these numbers is not explained.
Accordingly, the registry record supports a description of the study design, intended endpoint, and recorded safety entries. It does not support a conclusion about the size or precision of a PFS outcome, a comparative treatment effect, or whether an observed event pattern differs from another treatment. Those questions require results and analysis details that are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why the design and completeness of a registry record are as important as the stated clinical question. The study sought to examine progression-free survival with sunitinib and capecitabine in first-line metastatic colorectal cancer, but it is recorded as a single-group study with no comparator. That design distinction determines what the data could establish: a group’s outcomes can be described, but a difference relative to another treatment cannot be estimated directly.
The endpoint is defined, and the registry specifies a median with full range over a 36 months timeframe. Yet the result itself is absent. Without a posted estimate or uncertainty measure, readers cannot assess either the observed PFS distribution or the precision of an estimate. A registered endpoint is not a substitute for a reported result. The record also has zero analysis records, so a statistical method or primary analysis cannot be checked against the endpoint definition.
The enrollment entry of 50 and the safety group’s 11 participants at risk also underscore the importance of reporting analysis populations and denominators. The record does not explain whether the entries refer to different stages of participation or different data sets. Without that information, the scope of the safety counts and their relation to the trial enrollment remain unclear.
For biostatistical interpretation, the practical lesson is to separate study intent, design, observed outcomes, and inference. Planning assumptions are not a trial-specific justification or evidence of observed power. Descriptive safety entries are not comparative effects. A terminated status is not an explanation for why the study ended. Keeping these distinctions explicit prevents missing registry information from being mistaken for a null result or a complete analysis.
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 of the posted record is the absence of a primary PFS estimate. Although the endpoint is defined as months from enrollment to progression or death and is specified as a median with full range, neither summary is reported. No confidence interval, hazard ratio, p-value, or analysis method is available. The precision and distribution of PFS therefore cannot be evaluated.
The study is identified as single-group, with allocation marked NA and no masking. There is no concurrent comparator, so the design does not permit a like-for-like treatment comparison. This is a limitation for causal interpretation even if a descriptive endpoint result were available. The registry also does not report the protocol, detailed statistical plan, or rationale for the enrollment target.
The record lists enrollment as 50, but the safety group lists 11 at risk. The reason for this difference and the number included in the PFS analysis are not reported. The status is terminated, with no termination reason recorded. The registry does not clarify whether the listed enrollment was reached, the duration of participant follow-up, or completeness of endpoint assessment.
Further details relevant to time-to-event interpretation are absent: the progression assessment rules, censoring method, handling of missing data, analysis population, and any sensitivity analyses. The serious-event entries do not include event timing, treatment attribution, or cause of death. These limitations concern what can be understood from the registry record and should not be interpreted as evidence that the omitted procedures or data did not exist.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Sunitinib and Capecitabine for First Line Colon Cancer — NCT00961571.
- Registry record last updated 2025-02-12; status last verified 2025-02.
- Results first posted 2017-04-21.
- 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
The registry record describes NCT00961571, a single-center Phase II trial sponsored by Georgetown University. It lists sunitinib and capecitabine for first-line treatment of metastatic colorectal cancer among patients not previously treated with chemotherapy for their cancer. The study is single-group, with allocation listed as NA and no masking. Enrollment is listed as 50; status is terminated.
The primary outcome is progression-free survival, defined as months from enrollment to progression or death, with a 36 months timeframe and a median with full range as the specified summary. The registry does not report a primary outcome value or a statistical analysis. The safety entry lists 11 participants at risk, 8 affected by serious events, 11 affected by other events, and 1 death. The reason for termination, analysis population, and relationship between the enrollment and safety entries are not reported in the registry record.