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 Evaluation of Outcomes in Women Undergoing Multimodality Treatment for Advanced Stage Endometrial Carcinoma (NCT04743999), a na phase 2 study. The primary outcome is Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04743999 |
| Phase | Phase 2 |
| Condition | Endometrial Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Henry Ford Health System |
| Results posted | Yes |
2. Clinical Question
Population
Women with advanced-stage endometrial carcinoma are the population described. The study description specifically refers to FIGO stage III uterine carcinoma after surgical staging. The registry lists endometrial cancer as the condition. The registry enrollment is 9; the study description states an intended enrollment of 60. The record does not provide a fuller description of eligibility criteria or the characteristics of participants enrolled.
Intervention
The study concerns multimodality adjuvant treatment involving concurrent chemotherapy and radiation therapy. The description identifies carboplatin and paclitaxel-based chemotherapy, with radiation during chemotherapy cycles 1-3. The listed intervention is a quality-of-life questionnaire, rather than a randomized treatment assignment. The record does not provide participant-level treatment exposure or completion details.
Comparator
There is no separate comparison group. The registry identifies a single-group study with allocation listed as not applicable and no masking. Consequently, the record does not support a direct randomized comparison of this regimen with another treatment strategy. Changes over the scheduled assessment times could be described within the group if results were reported, but they would not by themselves establish a treatment contrast.
Primary question
The primary question concerns physical and functional well-being measured using the FACT-G questionnaire at baseline and follow-up. The questionnaire description covers physical treatment side effects, such as pain, nausea, and fatigue, and functional impact, such as ability to work or enjoy hobbies. The primary measure is a mean score on a 0-4 scale, with standard deviation as the stated measure of dispersion. The registry record does not report the observed scores or their changes over time.
3. Trial Design
This is a prospective, phase 2, single-group study listed as terminated. The registry describes an evaluation of quality of life and treatment-related side effects among women undergoing multimodality treatment for advanced-stage endometrial carcinoma. It is not a randomized trial: allocation is listed as not applicable, and masking is listed as none. The listed intervention is a quality-of-life questionnaire, and the arm description identifies scheduled assessments following surgery and during follow-up.
The record lists a start date of 2020-02-27 and a primary completion date of 2023-06-27. Registry enrollment is 9. The study description states that 60 patients with FIGO stage III uterine carcinoma would be prospectively enrolled after surgical staging. These are different kinds of information: the stated enrollment goal describes the study plan, while the registry enrollment is the count recorded for the trial. The record does not explain why enrollment was below the stated goal or why the study was terminated.
The treatment description includes six cycles of carboplatin and paclitaxel, with radiation planned during chemotherapy cycles 1-3. It describes external beam radiation to the pelvis and provides dose details, but the treatment-plan text in the registry record is incomplete. The record does not establish which treatments each participant actually received, whether the regimen was completed, or whether treatment varied among participants.
Without a control group, the design can describe outcomes within the enrolled group but cannot provide a randomized estimate of the difference between treatment strategies. The registry record lists no statistical analyses. It also does not report a statistical analysis plan, sample-size justification, interim analyses, or the reasons for termination.
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.
Baseline Questionnaire
| Stage | Quality of Life Evaluation |
|---|---|
| STARTED | 9 |
| COMPLETED | 9 |
| NOT COMPLETED | 0 |
3-month Questionnaire
| Stage | Quality of Life Evaluation |
|---|---|
| STARTED | 9 |
| COMPLETED | 8 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Quality of Life Evaluation |
|---|---|
| Death | 1 |
6-month Questionnaire
| Stage | Quality of Life Evaluation |
|---|---|
| STARTED | 8 |
| COMPLETED | 7 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Quality of Life Evaluation |
|---|---|
| Study terminated due to low accrual | 1 |
12-month Questionnaire
| Stage | Quality of Life Evaluation |
|---|---|
| STARTED | 7 |
| COMPLETED | 6 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Quality of Life Evaluation |
|---|---|
| Study terminated due to low accrual | 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 | Quality of Life Evaluation |
|---|---|---|
| Participants analysed | 9 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 6 |
| Age, Categorical: >=65 years | Participants | 3 |
| Sex: Female, Male: Female | Participants | 9 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 |
| Race (NIH/OMB): White | Participants | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire, measured over Baseline, 3-month, 6-month, 12-month, 24-month.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is physical and functional well-being assessed with the Functional Assessment of Cancer Therapy - General questionnaire, identified as FACT-G. The registry describes it as a prospectively validated questionnaire addressing physical side effects of treatment, including pain, nausea, and fatigue, as well as functional impact, such as ability to work or enjoy hobbies. The response scale runs from 0 to 4, where 0 means “Not at all” and 4 means “Very much.”
The endpoint is specified as a mean score with standard deviation. In general, a mean describes the average observed score, while a standard deviation describes how spread out scores are around that average. These summaries can help characterize the group at each assessment time, but do not show the experiences of every individual participant. The listed time points are baseline, 3-month, 6-month, 12-month, and 24-month.
Repeated assessment is relevant to a quality-of-life question because physical well-being and functioning may be described at different points during follow-up. A pattern across assessments, if reported, could show how the group’s measured scores varied over time. It would not by itself establish that treatment caused a change, particularly in a single-group study without a concurrent control group.
The registry record does not report the observed primary endpoint scores, standard deviations, or changes between assessment times. It notes that values reported as “0.00 (0.00)” are accurate in all outcome measures; that general note does not identify a specific primary result or provide the missing assessment-level results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a prospective quality-of-life evaluation in women with advanced endometrial carcinoma receiving multimodality treatment. It records enrollment of 9 and lists the trial as terminated. The study description states an intended enrollment of 60. The primary outcome is defined, but the observed FACT-G means and standard deviations are not reported in the registry record. Therefore, the posted information does not show the group’s measured physical or functional well-being at baseline or follow-up, or whether scores changed over time.
The registry lists 4 outcome measures and 0 analyses. The primary outcome description specifies the instrument, score scale, summary measure, and assessment schedule, but a definition of an endpoint is not a result. Without observed values, there is no basis in this record to characterize the direction or magnitude of any quality-of-life pattern, or the precision of an estimated mean or change.
In general, a confidence interval expresses a range of values that are compatible with the data and the method used to calculate it. Its width conveys precision: a narrower interval indicates greater precision under that method, while a wider interval indicates less. The record does not report confidence intervals for the primary outcome, and it does not provide the underlying outcome data needed to assess precision independently. No inferential conclusion about change can be drawn from the endpoint description alone.
The single-group design is important to interpretation. If within-group scores had been reported, they could describe how the measured scores differed across scheduled times. Such a pattern would not isolate the effect of treatment from other influences over time, nor compare the treatment with another regimen or with no treatment. The registry does not list a randomized comparator, and the record does not report a statistical analysis addressing causal attribution.
The safety entries list 0 participants affected by serious adverse events and 0 affected by other adverse events in the quality-of-life evaluation group, with 1 death recorded. The record does not provide event terms or describe the relationship of the death to treatment. These counts should be read as registry entries, not as evidence that treatment caused or prevented an event.
Overall, the registry provides study-design context, a defined primary measure, enrollment information, and limited safety counts. It does not provide the primary outcome results or statistical analyses needed to assess observed quality-of-life scores, differences over time, or their uncertainty. The reason for termination and the completeness of follow-up are not reported in the registry record.
9. Statistical Methods Explained
The primary measure is continuous: it is a score on a scale, summarized as a mean and standard deviation. The registry record identifies the assessment instrument and time points, but does not report score results or analyses. The explanations below describe general statistical concepts; they do not imply that a particular analysis was conducted in this study.
What does a mean score describe?
In general, the mean is the arithmetic average of observed scores in a group at a specified assessment. It gives a compact description of the group’s central score, but can conceal variation among participants. A mean alone does not show whether scores were clustered closely or spread broadly, nor whether some participants had substantially different experiences from the group average.
The standard deviation is a measure of the spread of individual scores around the mean. A larger standard deviation indicates more variation in scores within the group, while a smaller one indicates less variation. It is not the same as a confidence interval: the standard deviation describes dispersion among observations, whereas a confidence interval describes uncertainty in an estimated quantity. The registry specifies standard deviation but reports no values for the FACT-G assessments.
How should repeated assessments be understood?
The planned schedule includes baseline and follow-up at 3-month, 6-month, 12-month, and 24-month assessments. Repeated measurements can describe the course of a score over time. Because measurements from the same participant are related, analyses of repeated data generally need to account for that within-person relationship. General approaches may compare change from baseline or model observations across visits, but the registry does not state which approach was planned or used.
Interpretation of a change also depends on what observations are available at each assessment and on how missing observations are handled. If the participants contributing data differ across visits, a difference between group means can reflect both changes in scores and changes in who was observed. The registry record does not report the number assessed at each time, the amount or pattern of missing outcome data, or a missing-data method. It is therefore not possible to determine whether follow-up summaries, if any, would represent the same participants at each time.
What would a confidence interval add?
In general, a confidence interval places an estimated mean or change in the context of sampling uncertainty under a stated statistical method. It provides information beyond a point estimate: the interval’s location indicates which values are compatible with the data under that method, and its width indicates precision. An interval does not remove design limitations or establish causality. No confidence interval, standard error, or test result for the primary outcome is reported in the registry record.
A p-value, if reported, would address how compatible the data are with a specified null hypothesis under the assumptions of a test. It would not measure the size or importance of a change, and it would not correct for the absence of a comparator. The registry lists 0 analyses and provides no p-value or inferential procedure for the primary endpoint. Statistical significance therefore cannot be assessed from the posted results.
What can a single-group design estimate?
In general, a single-group study can describe observed scores within the enrolled group. It can report a mean at an assessment or a within-group change if data and an analysis are available. A randomized comparison uses a separate group assigned to a different strategy to estimate a treatment contrast under the study design. This registry identifies no such comparison. Observed before-and-after differences, if they had been reported, could not by themselves separate treatment effects from time, other care, disease course, or changes in who completed assessments.
How should planning calculations be read?
Any sample-size values associated with planning are illustrations, not observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Those assumptions do not describe this single-group study’s actual allocation or establish that the trial was designed using that calculation. The registry record does not report the trial’s own sample-size justification or statistical plan. Planning calculations cannot substitute for observed outcomes, and they do not establish the probability that a finding is true.
The underlying outcome data, analysis choices, and uncertainty measures would be needed to evaluate the primary endpoint statistically. With the available registry information, the endpoint is defined but the estimated scores, changes, and precision remain not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 4 outcome measures, but the record describes only the primary measure in detail in the available study information. It lists 0 analyses. The statistical plan, including any prespecified approach to multiple outcomes or repeated assessment times, is not reported in the registry record.
In general, multiplicity arises when several outcomes, time points, or comparisons are tested. Conducting many tests can increase the chance of at least one apparently unusual result, even when there is no underlying difference. Statistical plans may address this by identifying a primary outcome, prioritizing comparisons, or adjusting the interpretation of multiple tests. The record names a primary outcome but does not state how results across the listed outcomes and assessments would be handled.
The record does not report the number of participants with an observed FACT-G score at each assessment, the amount or pattern of missing data, or an imputation or other missing-data method. The listed assessment schedule does not establish that every participant completed every questionnaire. In general, missingness can affect estimates when the availability of an outcome is related to participants’ scores or circumstances. Without follow-up counts and a stated method, the extent and consequences of missing data cannot be assessed.
Analysis populations are also not described. The registry record does not state which participants would be included in each outcome analysis, or whether analyses used all enrolled participants, participants with available questionnaires, or another defined population. These choices can affect the interpretation of an estimate. No analysis population should be inferred from the enrollment count alone.
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 |
|---|---|---|---|
| Quality of Life Evaluation | 0 | 9 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Quality of Life Evaluation | 1 of 9 |
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 |
|---|---|
| Quality of Life Evaluation | 0 of 9 |
For the quality-of-life evaluation group, the registry lists 9 at risk for serious adverse events and 0 affected. It also lists 9 at risk for other adverse events and 0 affected. The record identifies no top serious adverse-event terms. These are the registry’s reported counts; the record does not provide event-level descriptions or additional detail about how the entries were collected.
The same group has 1 death recorded. The registry entry does not state whether the death was considered treatment-related, whether it occurred during a particular treatment period, or how it relates to the adverse-event counts. It should not be assumed to be caused by treatment or unrelated to treatment based on the information reported.
Counts of zero in the adverse-event fields do not establish that no event could have occurred outside the recorded definitions, observation period, or reporting process. The registry record does not provide those details. The counts also do not allow a comparison of safety between treatment strategies, because the study is single-group and has no comparator. They are descriptive entries for this registry group, not a comparative estimate of risk.
12. What the Result Does, and Does Not, Mean
The record establishes that a prospective phase 2, single-group study was registered to assess quality of life and treatment-related side effects in women undergoing multimodality treatment for advanced endometrial carcinoma. It identifies FACT-G physical and functional well-being as the primary outcome, describes the score scale and summary measure, and lists planned assessment times. It also records enrollment of 9, a terminated status, and limited safety counts.
The record does not report the observed primary outcome scores, standard deviations, or changes over time. It therefore cannot show whether the group’s physical or functional well-being was higher, lower, or stable across assessments, or how precisely any estimate was measured. The absence of reported results is not evidence that scores were unchanged or that a particular outcome occurred.
The design also limits what the study could establish about treatment effects. A single group can provide descriptive information about its participants, but without a concurrent comparison group it cannot estimate a randomized difference between treatment strategies. A pattern of change over time, even if reported, would not alone establish that treatment caused that pattern. The registry record does not report analyses that address causal effects.
The listed safety counts provide limited descriptive information, including 0 serious adverse events affected, 0 other adverse events affected, and 1 death. The record does not explain the relation of the death to treatment or provide event details. These entries cannot support a comparative safety conclusion.
In general, a registry entry is a record of study information and reported outcomes, not a substitute for complete outcome data and analysis details. Here, the primary endpoint is specified, but its results, uncertainty, missing-data handling, analysis populations, and statistical methods are not reported in the registry record. The reason for termination and the completeness of follow-up are also not reported. Conclusions should remain limited to the design and entries recorded.
13. Why This Trial Matters Statistically
This study is statistically notable for defining a patient-reported quality-of-life endpoint in a prospective evaluation of multimodality treatment. Clinical outcomes are not limited to disease measures: a structured questionnaire can capture physical symptoms and functional impact that matter to the experience being studied. The registry identifies FACT-G, explains its score scale, and specifies baseline and follow-up assessments.
The single-group structure is central to the statistical question. It allows an evaluation to describe scores within the enrolled group if those scores are reported, but it does not provide a randomized treatment comparison. This distinction helps separate descriptive monitoring from estimation of a treatment contrast. Even a clear within-group pattern would require cautious interpretation as an association over time rather than proof that the regimen caused the pattern.
The gap between the stated intended enrollment of 60 and registry enrollment of 9 is relevant context for reading the record. A small recorded enrollment can constrain the amount of information available, but the record does not provide outcome values or uncertainty estimates with which to assess that constraint quantitatively. It also does not report why enrollment ended below the stated target or why the study was terminated.
More broadly, specifying an outcome and assessment schedule is not enough to evaluate the observed effect. Readers need the actual scores, the number assessed at each time, an account of missing data, analysis methods, and uncertainty measures. Those details are not reported in the registry record. The study therefore illustrates why a defined endpoint and a registry status should be distinguished from an analyzable set of results.
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 trial-specific limitation of the posted record is that it defines the primary FACT-G endpoint but does not report its observed values. No means, standard deviations, changes, confidence intervals, or test results are available in the registry record. The record lists 4 outcome measures and 0 analyses, so the broader outcome findings and statistical interpretation are also not described.
The study is single-group, with allocation listed as not applicable and masking listed as none. There is no randomized comparator from which to estimate a treatment contrast. The study can only support descriptive interpretation of the group if results are available; it cannot, on this record, separate treatment effects from other changes over time.
The registry enrollment is 9, whereas the study description states an intended enrollment of 60. The record does not explain the difference, the reason for termination, or whether all scheduled assessments were completed. It does not report the number contributing data at each time, participant characteristics, or the amount and pattern of missing outcome data. These omissions prevent assessment of follow-up completeness and the representativeness of available scores.
The record does not report a statistical analysis plan, sample-size justification, analysis populations, handling of repeated observations, multiplicity approach, or missing-data method. The treatment description is incomplete, ending mid-sentence, and the record does not provide participant-level exposure or treatment completion. The safety entries provide counts but no event terms or explanation of the death’s relationship to treatment. These limitations restrict interpretation of both quality-of-life and safety findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Outcomes in Women Undergoing Multimodality Treatment for Advanced Stage Endometrial Carcinoma — NCT04743999.
- Registry record last updated 2024-03-29; status last verified 2024-03.
- Results first posted 2024-03-29.
- 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 identifies a prospective, phase 2, single-group study of quality of life during multimodality treatment for advanced endometrial carcinoma. It lists Henry Ford Health System as sponsor, a start date of 2020-02-27, a primary completion date of 2023-06-27, terminated status, and enrollment of 9. The study description states an intended enrollment of 60.
The primary outcome is mean FACT-G physical and functional well-being score, with standard deviation, assessed at baseline, 3-month, 6-month, 12-month, and 24-month time points. The score scale is 0-4. The registry lists 4 outcome measures and 0 analyses. Observed primary outcome results, analysis methods, and missing-data details are not reported in the registry record.
The safety entries list 0 serious adverse events affected, 0 other adverse events affected, and 1 death. The record does not state the death’s relationship to treatment or provide serious-event terms.