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 Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients w/ Body Surface Area (BSA) > 2.0 (NCT02756013), a na phase 2 study. The primary outcome is Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02756013 |
| Phase | Phase 2 |
| Condition | Gynecologic Malignancies |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Case Comprehensive Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerns overweight women with gynecologic malignancies and a body surface area greater than 2.0, as described in its title and summary. The primary outcome population is listed as participants who received treatment. The registry record does not report further eligibility details or how many enrolled participants received treatment.
Intervention
Participants were assigned to a single treatment group receiving paclitaxel and carboplatin. Paclitaxel was dosed using actual body surface area without capping at a body surface area of 2.0. Carboplatin dosing was to use the Calvert formula, with estimated glomerular filtration rate from the Cockcroft-Gault formula, and subject to maximum allowed doses.
Comparator
There was no separate comparator group. The registry record identifies a single-group model and no allocation. It therefore does not support a like-for-like comparison with another treatment, a capped-dose regimen, or a control group.
Primary question
The primary question was how much of the intended treatment plan participants completed, measured as mean relative dose intensity expressed as the percent of intended cycles completed. The registry record gives a timeframe of up to 190 days and identifies participants who received treatment as the population. It does not report the observed mean or full range, so the result of that evaluation cannot be described from the registry record.
3. Trial Design
This was a phase 2, single-group trial sponsored by Case Comprehensive Cancer Center. The registry record lists enrollment of 3, a single Paclitaxel + Carboplatin group, no allocation, and no masking. The trial status is terminated. Its start date is 2016-04-20 and its primary completion date is 2018-08-16. The registry record does not give a reason for termination.
The treatment plan specified paclitaxel based on actual body surface area, without a cap at body surface area 2.0. Carboplatin was to be calculated according to the Calvert formula using estimated glomerular filtration rate from the Cockcroft-Gault formula, with maximum allowed doses. These are descriptions of the intended dosing approach; the registry record does not report each participant’s delivered doses or adherence to that approach.
The primary outcome was mean relative dose intensity, measured as the percent of intended cycles completed, among participants who received treatment. Its timeframe was up to 190 days. A secondary outcome was the number of participants with progression-free survival, but the registry record does not give a result for that outcome or specify a numerical follow-up result.
Because the trial had one group and no allocation, it was not designed in the registry record as a randomized comparison. The record does not report a control regimen, a prespecified hypothesis, or a detailed statistical analysis plan. It also does not report the planned sample-size justification or any interim-analysis plan. The small enrollment and lack of posted numerical outcome results substantially limit what can be inferred about treatment delivery or clinical outcomes.
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 | Paclitaxel + Carboplatin |
|---|---|
| STARTED | 3 |
| COMPLETED | 1 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Paclitaxel + Carboplatin |
|---|---|
| Adverse Event | 1 |
| Hypersensitivity | 1 |
Analysis population for the primary outcome, as defined in the registry: Participants who received treatment
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: Participants who went on study
| Characteristic | Unit | Paclitaxel + Carboplatin |
|---|---|---|
| Participants analysed | 3 | |
| Age, Customized: 50-59 years | Participants | 2 |
| Age, Customized: 60-69 years | Participants | 1 |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | 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 | 1 |
| Race (NIH/OMB): White | Participants | 2 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed, measured over Up to 190 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | percent of intended cycles completed |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was relative dose intensity, summarized as the mean percent of intended cycles completed. In practical terms, this endpoint describes treatment delivery: it compares the cycles completed by participants with the cycles intended in the therapeutic plan. The registry record describes prospective evaluation of the average percent completed and specifies participants who received treatment as the population. The timeframe was up to 190 days.
As a general statistical concept, a measure of treatment completion can help describe whether a planned regimen was delivered as intended. It is not, by itself, a measure of tumor response, disease control, or survival. A mean describes the group average, while a full range describes the lowest and highest observed values; together, they can convey both a central summary and the spread of individual experience. The registry record identifies the mean and full range as the endpoint summary but does not report their values.
The number of enrolled participants was 3, but the endpoint population is specifically participants who received treatment. The number in that population is not reported in the registry record. Without the endpoint value, its range, and the number assessed, the observed level and variability of treatment completion cannot be evaluated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a very small, single-group phase 2 trial with enrollment of 3. Its primary outcome was mean relative dose intensity, expressed as the percent of intended cycles completed, among participants who received treatment. Although the endpoint definition and timeframe of up to 190 days are reported, its numerical result is not reported in the registry record. The mean and full range therefore cannot be interpreted, and there is no basis in the record to quantify treatment completion or its variability.
The record also lists the number of participants with progression-free survival as a secondary outcome, but gives no numerical result for it. It reports 2 outcome measures and 0 analyses. No inferential results, effect estimates, or confidence intervals are reported in the registry record. Consequently, the precision of any estimate of the primary or secondary outcome cannot be assessed from the posted results.
The design limits interpretation independently of the missing outcome values. With a single group, there is no concurrent control group against which to estimate a treatment contrast. Even if outcome measurements had been posted, changes or outcomes in this group could not by themselves separate effects of the regimen from other explanations. This is a general limitation of uncontrolled studies, not a claim about what happened to participants.
The enrollment of 3 also means that each participant’s experience could substantially affect a group summary. This is a general statistical consideration for very small samples. The number enrolled should not be assumed to equal the number treated or the number included in the primary endpoint, because the registry record defines the endpoint population as participants who received treatment but does not report its size.
The registry status is terminated, but the reason and the circumstances of termination are not reported in the registry record. Termination alone does not establish whether the planned evaluation was completed, why enrollment ended, or whether the observed outcomes differed from expectations. Those details are not reported in the registry record.
The appropriate reading is therefore descriptive and limited: the record documents a dosing strategy, the planned endpoint, the trial’s design and enrollment, and a small set of safety counts. It does not provide numerical primary or secondary outcome results from which to judge the observed treatment completion or progression-free survival. It cannot establish a comparative effect, because no comparison group was included.
9. Statistical Methods Explained
The registry record identifies this as a phase 2, single-group study with no allocation and no masking. These design features determine what kinds of statistical conclusions are possible. There is no randomized allocation to contrasting groups and no comparator arm described. Accordingly, a between-group treatment effect is not available from this design as registered. The record does not report a detailed statistical analysis plan, so the precise planned methods beyond the stated endpoint summary are not reported in the registry record.
What does the primary summary describe?
The primary endpoint is a mean: the average percent of intended cycles completed among participants who received treatment. The accompanying full range is intended to describe the extent of observed values from the lowest to the highest. As a general statistical concept, the mean is a measure of location and the range is a measure of spread. The range can show whether participant-level values vary, but in a very small group it may be especially sensitive to individual observations. The registry record reports the planned summary type, not the numerical mean or range.
The endpoint is a measure of treatment delivery rather than a direct measure of clinical benefit. Its interpretation depends on knowing the intended plan and how completion was measured; the registry record describes the endpoint as the average percent of completed cycles out of the intended therapeutic plan. It does not report participant-level values, endpoint denominators, or the number who received treatment.
What can be inferred without a comparator?
As a general statistical concept, a control group provides a reference for estimating how outcomes differ under alternative conditions. A single-group study can describe outcomes in the treated participants, if those outcomes are reported, but it cannot estimate a randomized contrast against another regimen. The registry record lists allocation as none and the model as single group. Therefore, comparative efficacy claims are not supported by the registered design. This does not indicate what a comparison would have found; no such comparison is reported.
How should the planning illustrations be understood?
The registry’s sample-size assumptions describe planning illustrations computed from an observed effect, not the trial’s own design. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the illustrations give the total number of events using Schoenfeld, while other illustrations give participants per arm. These are hypothetical planning conventions, not features of the registered single-group trial. They do not represent observed power.
As a general statistical concept, a sample-size calculation asks what sample size would be required under assumptions about the target effect, variability or event pattern, significance level, and allocation. It is not a retrospective measure of whether a study had adequate power, and it cannot supply a missing result. The registry record does not give the numerical observed effect used for these illustrations or the numerical planning outputs in the registry record for this analysis. It also does not report the trial’s own sample-size justification. The illustrations therefore should not be read as the registered design or as evidence about what the trial detected.
What do precision and uncertainty mean?
As a general statistical concept, a confidence interval expresses the uncertainty around an estimate under a specified statistical model. A narrow interval indicates greater precision under that model, while a wide interval indicates less precision. No confidence interval for the primary endpoint or progression-free survival is reported in the registry record, nor is a numerical estimate available to accompany one. Precision cannot be assessed merely from the endpoint definition or the enrollment count.
Similarly, a p-value requires a defined statistical test and a numerical result. The registry record reports 0 analyses, and no p-value or inferential test result is reported. A missing p-value should not be interpreted as a non-significant finding; the record does not report a numerical test result from which significance could be judged.
Why might dispersion matter?
As a general statistical concept, dispersion describes variation among individual observations. If a group’s outcomes vary more than a statistical model assumes, methods that assume less variation can give misleading standard errors and uncertainty estimates. This issue is often discussed as over-dispersion when observed variability exceeds a model’s expectation. No model fit, dispersion estimate, or analysis of participant-level endpoint data is reported in the registry record. Over-dispersion therefore cannot be evaluated for this trial from the reported information.
The reported endpoint uses a mean and full range, rather than a model-based comparison. Without the actual endpoint values, the number assessed, or further analysis details, it is not possible to examine the distribution, assess influential observations, or determine whether an alternative summary would be useful. These are general considerations for interpreting a small-sample mean, not conclusions about unreported data.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 2 outcome measures: mean relative dose intensity as the primary outcome and the number of participants with progression-free survival as a secondary outcome. It reports 0 analyses and does not provide numerical outcome results, p-values, confidence intervals, or a detailed statistical analysis plan. Whether any additional outcomes or statistical tests were planned is not reported in the registry record.
As a general statistical concept, multiplicity arises when several outcomes, comparisons, or statistical tests are considered. Without a prespecified approach, repeated testing can make chance findings more likely across a set of tests. The registry record does not describe a multiplicity adjustment or testing hierarchy, so it is not possible to determine how multiple outcomes would have been handled. The existence of a primary and a secondary outcome alone does not establish what testing procedure was planned.
The primary endpoint population is described as participants who received treatment, while enrollment was 3. The number treated, the number contributing to the primary outcome, and the handling of participants with missing measurements are not reported in the registry record. It is therefore not possible to establish whether the endpoint was complete for all treated participants or how incomplete observations were handled.
The registry record does not identify an intention-to-treat population, a per-protocol population, or any other analysis population beyond participants who received treatment for the primary endpoint. It does not report imputation methods, exclusion rules, or sensitivity analyses. These omissions prevent assessment of missing-data assumptions and the consequences of any exclusions. As a general statistical matter, missingness can affect both the size and interpretation of an estimate, but its effect cannot be evaluated without information about what was missing and how it was handled.
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 |
|---|---|---|---|
| Paclitaxel + Carboplatin | 0 | 3 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Paclitaxel + Carboplatin | 1 of 3 |
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 |
|---|---|
| Paclitaxel + Carboplatin | 1 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Paclitaxel + Carboplatin |
|---|---|---|
| Peripheral neuropathy | Nervous system disorders | 1 of 3 |
The registry safety summary lists the Paclitaxel + Carboplatin group with 3 participants at risk for serious adverse events and 0 participants affected by serious adverse events. It lists 3 participants at risk for other adverse events and 1 participant affected. The summary also lists 1 death. These are counts as recorded; the registry record does not report event details, causes, timing, or a narrative explaining the death.
The terms “at risk” and “affected” are counts of participants, not necessarily counts of individual events. The serious adverse event summary lists no serious adverse event terms. That means the record does not provide a term-level description of serious events; it should not be expanded into claims about specific event types or circumstances. The record also does not state whether the listed death was related to treatment.
As a general statistical consideration, counts from a group with few participants give limited information about how frequently events might occur in a broader population. The counts describe only the safety information reported for this group. They do not establish whether the regimen caused an event, and they should not be used to compare safety with another treatment because no comparator group is reported.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a phase 2, single-group study evaluated a dosing approach combining paclitaxel based on actual body surface area with carboplatin dosing calculated using the stated formulas and subject to maximum allowed doses. It also identifies mean percent of intended cycles completed as the primary endpoint, with participants who received treatment as the endpoint population and a timeframe of up to 190 days.
What the record does not establish is the observed primary endpoint value. It reports no numerical mean or full range for relative dose intensity. It also gives no numerical result for the secondary outcome of the number of participants with progression-free survival. The record therefore does not show how much of the planned treatment was completed or what progression-free survival findings were observed.
The study enrolled 3 participants and had no comparison group. As a general statistical concept, a single-group outcome can be descriptive, but it cannot provide a randomized estimate of how outcomes differ from a comparator. The record does not support conclusions about comparative effectiveness, superiority, equivalence, or non-inferiority. Such conclusions would require information and a design that are not reported.
The safety summary reports 0 participants affected by serious adverse events, 1 participant affected by other adverse events, and 1 death among the listed group, with 3 at risk in each category. The registry record does not give details needed to interpret the cause, timing, or treatment relationship of the death. These counts are not a comparative safety estimate.
The trial status is terminated. The reason for termination is not reported in the registry record, and the status alone does not explain whether termination related to recruitment, safety, feasibility, or any outcome. Overall, the record provides the trial’s design, intended endpoint, dosing description, enrollment, and limited safety counts, but not the numerical outcome evidence needed to characterize treatment completion or progression-free survival.
13. Why This Trial Matters Statistically
This trial raises a statistical question about how treatment delivery is evaluated when dosing is based on actual body surface area in a population described as overweight and with body surface area greater than 2.0. The registered primary endpoint, relative dose intensity measured as mean percent of intended cycles completed, focuses on whether participants completed the intended treatment plan. That is distinct from a comparative clinical outcome and makes clear why endpoint definitions matter: the endpoint determines what a result can describe.
The registry record also illustrates how design constrains inference. A single-group study can describe a treatment experience, but without a comparator it cannot estimate a randomized difference between dosing strategies. The title and dosing description identify the approach under evaluation, but there is no separate group receiving a capped-dose approach or another regimen in the registry record. A design question about dosing is not, by itself, a comparative result.
Enrollment of 3 makes transparent reporting of denominators and individual variability particularly important. The primary outcome population is participants who received treatment, yet the number in that population is not reported. The mean and full range are specified, but their values are absent. Without these details, readers cannot assess the observed treatment completion or how representative a group average might be of individual participants.
The missing numerical outcomes also demonstrate the difference between a registered question and a reported answer. The record identifies a secondary progression-free survival outcome, but no result is reported. It lists safety counts, but not event descriptions or context for the death. Clear outcome reporting is necessary for readers to distinguish what was planned, what was measured, and what can be concluded.
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 central limitation is that numerical results for the primary and secondary outcomes are not reported in the registry record. The primary endpoint’s mean and full range are absent, as is a numerical result for progression-free survival. The record reports 0 analyses, so there is no reported inferential analysis to assess.
The enrolled group was small, with 3 participants, and the registered design was single group with no allocation and no masking. There was no comparator group, so the record cannot support a direct treatment contrast. The number enrolled is not necessarily the number treated or the number included in the primary endpoint; the number who received treatment is not reported.
The registry record does not report the reason for termination, the sample-size justification, an interim-analysis plan, or a detailed statistical analysis plan. It does not specify how missing endpoint data were handled, whether any participants were excluded from an analysis, or how outcome multiplicity was addressed. These details are needed to evaluate the analysis process and its assumptions.
Safety interpretation is also constrained. The record gives participant counts, but no serious adverse event terms and no details about the other adverse event or the listed death. The cause, timing, and relationship to treatment are not reported in the registry record. Consequently, the safety counts are descriptive and cannot establish causation or support a comparison with another regimen.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients w/ Body Surface Area (BSA) > 2.0 — NCT02756013.
- Registry record last updated 2022-06-30; status last verified 2022-06.
- Results first posted 2020-08-06.
- 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
NCT02756013 is a phase 2, single-group trial sponsored by Case Comprehensive Cancer Center. It enrolled 3 participants and is listed as terminated. The registered treatment group combined paclitaxel dosed by actual body surface area, without a cap at 2.0, and carboplatin calculated using the Calvert formula with estimated glomerular filtration rate from the Cockcroft-Gault formula, subject to maximum allowed doses.
The primary endpoint was mean relative dose intensity, expressed as percent of intended cycles completed, among participants who received treatment, over up to 190 days. Progression-free survival was listed as a secondary outcome. Numerical results for these outcomes are not reported in the registry record. The safety summary lists 0 participants with serious adverse events, 1 with other adverse events, and 1 death; further details are not reported in the registry record.