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 Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer (NCT04515004), a na phase 2 study. The primary outcome is Delay in the Planned Surgery of >14 Days That is Possibly Related to Study Medication (Safety and Feasibility)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04515004 |
| Phase | Phase 2 |
| Condition | Early Stage Lung Cancer (I and II) |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
People with early stage lung cancer, described in the registry as stages I and II. Specific eligibility criteria and participant characteristics are not reported in the registry record. The brief summary discusses veterans as a population at higher risk, but does not establish that every eligible participant had to be a veteran.
Intervention
Oral leucoselect phytosome, a grape seed extract formulation described in the brief summary as having enhanced absorption. The arm description states that participants meeting entry criteria would receive treatment for 2-3 weeks before surgery.
Comparator
There was no comparison group in the single-group design. The registry lists allocation as not applicable and masking as none. The study therefore was not designed as a randomized, controlled comparison.
Primary question
Whether planned surgery would be delayed by more than 14 days for a reason possibly related to the study medication. This was framed as a safety and feasibility outcome, not as a measure of whether the intervention changes cancer outcomes.
The study was intended to examine use of leucoselect phytosome as a presurgical intervention. In this setting, a surgery-timing measure can address whether study treatment is associated with a clinically relevant disruption to planned care. The endpoint focuses on a delay possibly related to the medication; it does not by itself evaluate tumor response, recurrence, or survival.
The registry record lists the trial as terminated and explicitly states that no participants received the intervention. It also states that data were not collected because of early termination and will not be collected in the future. As a result, the clinical question remains unanswered by observed trial outcome data. The registry enrollment field lists 6, but that entry should not be read as evidence that participants received treatment or contributed endpoint observations in light of the explicit statement about intervention and data collection.
Secondary outcomes were tumor Ki-67 labeling index, histopathology of resected tumor and lymph nodes, and tumor activated caspase 3. These measures concern biological or pathological features, whereas the primary endpoint concerns delay to surgery. The record does not report results for any of these outcomes.
3. Trial Design
This was a phase 2, single-group study sponsored by the VA Office of Research and Development. The registry lists allocation as not applicable, masking as none, and the model as single group. It describes an intervention arm in which qualified participants would receive oral leucoselect phytosome for 2-3 weeks. No control arm is listed, so there is no concurrent group for estimating how surgery timing or tumor measures would have differed without the intervention.
The study was intended to investigate presurgical treatment for early stage lung cancer, identified in the record as stages I and II. Its stated primary outcome was a safety and feasibility measure: a planned surgery delay of more than 14 days that was possibly related to study medication. Listed secondary measures concern Ki-67 labeling index, pathological response in resected tumor and lymph nodes, and activated caspase 3. The registry lists 16 outcome measures in total, but does not report results for them.
The record lists the study status as terminated. It explicitly says that no participants received the intervention, that outcome data were not collected due to early termination, and that data will not be collected in the future. Although the enrollment field lists 6, the record does not give a reconciliation between that field and the statement that no participants received treatment. It is therefore important to distinguish the enrollment entry from treatment exposure and outcome availability.
The start date is listed as 2023-11-20 and the primary completion date as 2024-11-01. The protocol's reasons for termination, details of any recruitment activity, and the timing of the termination are not reported in the registry record. The record also does not report the planned sample-size justification or a detailed statistical analysis plan.
Because this was a single-group study with no participants receiving the intervention, it cannot yield an estimate of a treatment-versus-control difference. Nor can it describe observed outcomes under the planned intervention. The design as registered and the actual study status must both be considered when interpreting the endpoint and the absence of results.
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 | Intervention |
|---|---|
| STARTED | 6 |
| COMPLETED | 6 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
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 | Intervention |
|---|---|---|
| Participants analysed | 6 | |
| Age, Customized: Age range: 66-79 | participants | 6 |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Delay in the Planned Surgery of >14 Days That is Possibly Related to Study Medication (Safety and Feasibility)., measured over No greater than 14 days delay in planned surgery..
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerned delay in planned surgery: specifically, whether a delay of more than 14 days was possibly related to study medication. The registry describes the endpoint as a safety and feasibility measure and gives the timeframe as no greater than 14 days delay in planned surgery. In practical terms, this endpoint was intended to capture whether the presurgical study intervention interfered with the timing of the planned operation by a specified amount, with a possible medication relationship.
As a general statistical concept, a feasibility endpoint can help assess whether a study procedure can be carried out without disrupting the clinical pathway it is meant to precede. A safety endpoint can identify a possible treatment-related concern. A surgery-delay measure can therefore be relevant to a presurgical study, but it is not a direct measure of tumor shrinkage, pathological response, recurrence, or survival. The endpoint also includes a judgment about possible relation to study medication; the criteria for making that judgment are not reported in the registry record.
The registry provides no observed endpoint data. It explicitly states that no participants received the intervention and that data were not collected because of early termination. The endpoint's observed frequency, statistical estimate, and uncertainty are consequently not available. The registry record does not report a statistical parameter or dispersion measure for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that this study has no reported primary outcome observations. The registry states that the study was terminated before any participants received leucoselect phytosome and that data were not collected due to early termination. Thus, the primary endpoint cannot indicate how often surgery was delayed by more than 14 days for a reason possibly related to the study medication. It also cannot establish whether the planned safety and feasibility criterion was met.
The registry enrollment field lists 6. That entry does not alter the explicit statement that no participants received the intervention and no outcome data were collected. Enrollment, treatment exposure, and availability of endpoint data are different concepts. In this record, the enrollment entry should not be treated as a treated analysis population, nor as evidence that primary outcome observations exist. The reason for any difference between the enrollment field and the intervention and data-collection statements is not reported in the registry record.
The design was single group, with no comparator and no masking. Even if outcome data had been collected, a single-group result would describe outcomes in the treated group rather than estimate a randomized contrast. Without a control group, changes or events could not be attributed to treatment by comparison with concurrent control outcomes. In the actual record, the absence of treatment exposure and outcome data means even a descriptive estimate is unavailable.
The listed secondary outcomes do not supply an alternative basis for judging the study's effects: the registry reports no results for tumor Ki-67 labeling index, histopathology of resected tumor and lymph nodes, or activated caspase 3. The record lists 16 outcome measures and 0 analyses, but does not report analysis estimates or inferential results. Statistical significance, confidence intervals, and precision for the primary or secondary outcomes are not reported in the registry record.
The record's adverse-event listing shows 0 at risk and 0 affected in the intervention group for both serious and other events, with 0 deaths. Because the record says no participants received the intervention, these entries do not provide an informative estimate of adverse-event risk under treatment. They should not be interpreted as evidence that the intervention caused no adverse events.
Any sample-size planning illustration should be distinguished from evidence produced by this trial. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a fraction of the observed effect. Such assumptions describe a hypothetical planning exercise, not this trial's single-group design. With no reported outcome observations, there is no observed effect from this trial to support an effect-based planning interpretation. Sample-size illustrations are not observed power, and none can replace the missing outcome data.
Overall, the registry supports conclusions about the intended design, the planned endpoint, and the study's termination and data-collection status. It does not support conclusions about safety, feasibility, biological response, or clinical benefit. These are limits of the available record, not evidence for either a favorable or an unfavorable treatment effect.
9. Statistical Methods Explained
What does a single-group design estimate?
In a single-group study, outcomes are observed in one group receiving the planned intervention. If participants are treated and followed, the design can describe what happened in that group. Without a comparator, it does not directly estimate the difference between outcomes under intervention and outcomes under an alternative. General statistical principle: a comparison group helps distinguish an intervention-associated pattern from background events, changes over time, or other influences. The registry lists no comparator, and the actual record says no participants received the intervention, so this study has no observed treated-group outcome estimate either.
The registry lists allocation as not applicable and masking as none. Allocation describes how participants are assigned to groups; masking concerns whether participants or study personnel know the assigned intervention. With a single-group design and no comparator, there was no randomized group assignment to conceal. The record does not report additional procedures for outcome assessment or adjudication. Those details matter particularly for an endpoint that includes a judgment that a delay was possibly related to study medication.
How should the surgery-delay endpoint be understood?
The primary endpoint was a safety and feasibility measure based on a planned surgery delay of more than 14 days possibly related to study medication. For a binary endpoint, the usual conceptual summary would distinguish whether the specified event occurred or did not occur. The registry does not report the endpoint's statistical parameter, and there are no outcome data from which to estimate an event frequency. The record's timeframe says no greater than 14 days delay in planned surgery, while its endpoint description defines the event in terms of a delay of more than 14 days possibly related to medication.
As a general statistical matter, a confidence interval expresses uncertainty around an estimate, with narrower intervals indicating greater precision under the method's assumptions. No estimate or confidence interval is reported for this endpoint. With no observations, there is no precision interval to interpret. A significance test likewise requires observed data and a defined analysis; no test result is reported, and the registry lists 0 analyses.
What can a planning calculation tell a reader?
Sample-size calculations are prospective planning tools: they describe the amount of information a future study might need under chosen assumptions. The stated assumptions for the planning illustration 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 fraction of the observed effect. These are assumptions for an illustration, not a description of the registered single-group design, which has no two-arm comparison.
For planning based on an effect observed in an earlier dataset, the uncertainty and relevance of that effect are important. As a general principle, a planning estimate based on an observed effect can be sensitive to how that effect was estimated and to whether the future setting is comparable. The registry does not report a trial outcome effect, and no outcome observations were collected. Any planning illustration should therefore not be read as a power analysis based on an effect observed in this trial. Planning sample sizes are not observed power: power is a prospective design quantity under assumptions, while observed power cannot substitute for an estimate and its uncertainty.
The sample-size assumptions refer to equal allocation between two arms, whereas the trial itself is identified as single group. This distinction matters because calculations built for a controlled comparison answer a different planning question from a single-arm feasibility study. The detailed calculation methods, the effect values used, and the resulting sample-size estimates are not reported in the registry record. A protocol-based sample-size justification is also not reported in the registry record.
Why do over-dispersion and outcome structure matter in general?
General statistical explanation: an analysis model is chosen to match the type and variability of an outcome. For count data, a simple model may assume variability is tied closely to the mean. Over-dispersion means the observed variation is greater than that assumption allows. If it is ignored, uncertainty can be understated and inferential conclusions can be too confident. This concept is not a reported feature of the primary endpoint in this study; the registry does not specify a count model or report outcome data.
Likewise, outcomes measured at different times, outcomes with different scales, and outcomes that depend on pathology assessment may require different summaries and modeling choices. The registry lists tumor Ki-67 labeling index, pathological response of resected tumor and lymph nodes, and tumor activated caspase 3 as secondary outcomes. It does not report analysis methods for these outcomes, how measurements would be summarized, or whether analyses would adjust for other variables. Those choices cannot be inferred from the outcome names alone.
Multiplicity arises when several outcomes or statistical tests are examined. As a general principle, interpreting many tests without accounting for their number can increase the chance of seeing an apparently notable finding by chance. The record lists 16 outcome measures but reports 0 analyses and no results. A multiplicity adjustment or hierarchy for outcome testing is not reported in the registry record, so it is not possible to assess how the listed outcomes would have been incorporated into a confirmatory analysis.
In short, standard concepts such as confidence intervals, model fit, over-dispersion, and multiplicity explain how outcome analyses might be planned and interpreted in a completed study. They do not generate evidence when outcomes were not collected. Here, the principal statistical conclusion is about data availability: no participant received the intervention and no trial outcome data are available for estimation.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 16 outcome measures, including the primary surgery-delay endpoint and secondary measures of tumor Ki-67 labeling index, histopathology of resected tumor and lymph nodes, and activated caspase 3. It reports 0 analyses. A statistical testing hierarchy, multiplicity adjustment, or distinction between confirmatory and exploratory analyses is not reported in the registry record.
As a general statistical principle, multiplicity needs consideration when several outcomes or tests are evaluated. Testing multiple hypotheses can make chance findings more likely unless the analysis plan accounts for the testing strategy. In this study, there are no reported analyses or outcome data on which to assess that issue empirically. The listed outcome count alone does not establish how many statistical tests were planned or whether adjustments were intended.
The record explicitly states that no participants received the intervention, that data were not collected because of early termination, and that they will not be collected in the future. Consequently, there is no reported primary or secondary outcome dataset and no reported analysis population. The registry enrollment field lists 6, but does not explain its relationship to the statement that no participants received treatment. It should not be used to infer the number of treated participants or the number included in an outcome analysis.
Missing-data methods, reasons for any participant-level missingness, and an intention-to-treat or per-protocol analysis population are not reported in the registry record. This is not a case where the record describes partially observed outcomes and a method for handling them; it states that outcome data were not collected. Statistical methods for imputing individual missing measurements would not create the absent trial outcomes.
11. What the Result Does, and Does Not, Mean
The registry record establishes what the study intended to do and why its planned analysis cannot be interpreted as an outcome evaluation. It describes a presurgical, single-group intervention with a surgery-delay endpoint and several biological or pathological secondary outcomes. It also states that the study was terminated before any participants received leucoselect phytosome and that no outcome data were collected.
Accordingly, the record does not show whether the intervention was associated with a delay in surgery, whether the planned safety and feasibility condition was met, or whether any tumor marker or pathological measure changed. It does not give an estimate of treatment effect, an estimate of adverse-event risk under treatment, or a confidence interval that would indicate precision. The zero entries in the adverse-event listing are not evidence of a lack of risk when the record reports no treatment exposure.
The study also cannot establish that the intervention is beneficial or ineffective. A lack of outcome data is not a result favoring either conclusion. Moreover, the registered single-group design would not, even with observations, provide a randomized comparison with a control group. It would primarily describe outcomes in the treated group, subject to the limitations of an uncontrolled design.
General statistical principle: estimates depend on observations, and precision depends on the amount and structure of information available. When the record says no outcome data were collected, neither an effect estimate nor its uncertainty can be derived from trial outcomes. Sample-size planning illustrations, if considered, are planning tools under assumptions rather than observed results, and they cannot fill this evidentiary gap.
The appropriate interpretation is therefore narrow: the registry documents a terminated study, its intended intervention and endpoints, and the absence of intervention exposure and collected outcome data. It does not provide evidence about clinical efficacy, tumor response, surgery timing under treatment, or treatment safety.
12. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the difference between a registered research question and an answer supported by observations. The protocol description identifies a clear presurgical question about whether treatment might be associated with a substantial delay to planned surgery. But the registry also states that the study ended before anyone received the intervention and that outcome data were not collected. A well-defined endpoint is not itself evidence about that endpoint.
The record also highlights why enrollment, exposure, and analysis populations must be distinguished. The enrollment field lists 6, while the outcome description says no participants received treatment. The registry does not explain the relationship between those entries. Careful reading avoids treating the enrollment field as a treated sample or as a basis for estimating outcome frequencies.
There is also an important design distinction. The study is listed as single group, without masking or a comparator. Even if outcomes had been observed, the design would not estimate a randomized treatment contrast. Planning calculations that assume equal allocation between two arms address a different design question than the registered single-group study. These calculations should be understood as hypothetical planning, not as a result of the trial or evidence of observed power.
Finally, the record lists multiple secondary biological and pathological outcomes but reports no analyses. This makes the absence of a reported multiplicity strategy less consequential for interpreting results, because no results are available, while still emphasizing the importance of prespecifying outcome analyses in a completed study. The key statistical lesson is that design, data collection, and analysis status jointly determine what conclusions a registry record can support.
13. 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 is that the registry states no participants received the intervention and no outcome data were collected because of early termination. As a result, the primary and secondary outcomes have no reported observations, estimates, or measures of precision. The reason for termination is not reported in the registry record.
The enrollment field lists 6, but the record does not reconcile that entry with its explicit statement that no participants received treatment. The field cannot be used on its own to establish intervention exposure, an endpoint denominator, or an analysis population. Details about screening, consent, recruitment, and the disposition of any people considered for participation are not reported in the registry record.
The single-group design has no concurrent comparator, and masking is listed as none. Therefore, even had the planned outcomes been collected, the design would have been limited in its ability to distinguish treatment-associated outcomes from other influences. The registry does not report procedures for assessing whether a surgery delay was possibly related to study medication, nor details of outcome measurement or review.
The record does not report a statistical analysis plan, sample-size justification, methods for handling missing data, or a multiplicity strategy. It lists 16 outcome measures and 0 analyses, but provides no results. The adverse-event entries show 0 at risk and 0 affected, consistent with the stated lack of intervention exposure; they cannot characterize adverse-event risk under treatment. The planned treatment duration was 2-3 weeks, but the record reports no treatment adherence or exposure data. These limitations prevent statistical conclusions about safety, feasibility, or biological response.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer — NCT04515004.
- Registry record last updated 2026-02-17; status last verified 2026-01.
- Results first posted 2026-02-17.
- 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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17. Record Summary
The registry record describes a phase 2, single-group study of oral leucoselect phytosome before surgery for early stage lung cancer, identified as stages I and II. The intervention arm was planned to receive treatment for 2-3 weeks. The primary safety and feasibility outcome concerned planned surgery delays of more than 14 days possibly related to study medication. Secondary outcomes included Ki-67 labeling index, pathological response in resected tumor and lymph nodes, and activated caspase 3.
The study is listed as terminated. The record states that no participants received the intervention and that data were not collected due to early termination. It lists enrollment as 6, 16 outcome measures, and 0 analyses. No primary or secondary results are reported. The record does not report the reason for termination, detailed analysis methods, or a sample-size justification. Its entries therefore describe the study plan and status but do not provide outcome evidence about treatment safety, feasibility, or tumor response.