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 A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas (NCT02868892), a na phase 2 study. The primary outcome is Progression Free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02868892 |
| Phase | Phase 2 |
| Condition | Adenocarcinoma of the Cervix, Adenosquamous Cell Carcinoma of the Cervix |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Western Regional Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients with advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the cervix. The registry record lists an enrollment of 6.
Intervention
Pemetrexed, described in the protocol as 500 mg/m2 by intravenous infusion on an every three week schedule.
Comparator
No comparator group is listed. The study is recorded as a single-group study with allocation marked NA and no masking.
Primary question
How would progression-free survival be assessed among participants receiving pemetrexed, with follow-up framed over 2 years?
The study’s clinical question is descriptive rather than comparative. It concerns progression-free survival after the first administration of study drug among people with recurrent cervical adenocarcinoma. The record also includes adenosquamous cell carcinoma of the cervix in its condition list and describes the intended population as people with advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma.
Because there is no listed control group, the design cannot directly compare pemetrexed with another treatment or with no study treatment. A single-group outcome, if collected and analyzed, would describe what happened among participants enrolled in this study. It would not by itself separate the effect of the study intervention from other influences on outcomes.
The registry record does not report progression-free survival results. It states that the study closed because the investigator was no longer at the site, with no principal investigator transfer, data collection or statistical analysis. Therefore, the intended clinical question can be identified, but an answer based on analyzed study outcomes is not reported in the registry record.
3. Trial Design
The registry record classifies this as a Phase II study with a single-group model. Allocation is marked NA, and masking is listed as none. The intervention is pemetrexed, and no control arm or active comparator is recorded. The listed enrollment is 6. The sponsor is Western Regional Medical Center.
The intervention description specifies pemetrexed 500 mg/m2, administered on an outpatient basis every three weeks. It describes a 10 minutes intravenous infusion in 100 ml of saline, given by peripheral vein or central line on Day 1 of each 21 day cycle. This is the planned administration description; the record does not report how many participants actually received study drug or how many cycles were administered.
The study started in 2015-07, and primary completion is listed as 2017-07. Its current status in the record is terminated. These dates and status describe the registry entry; they do not establish the timing or completeness of participant follow-up.
The primary outcome is progression-free survival, with a timeframe of 2 years. Response rate and overall survival are listed as secondary outcomes. No outcome estimates or statistical analyses are reported. The primary-outcome population field states that the investigator was no longer at the site and that the study was closed with no principal investigator transfer, data collection or statistical analysis. That statement is central to interpreting the record: the planned design and outcomes are documented, but analyzed outcomes are not.
A single-group Phase II design can describe outcomes among enrolled participants, but it does not provide a randomized or like-for-like control comparison. Any comparison with outcomes from other studies would require information about those other populations and methods that is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Pemetrexed |
|---|---|
| STARTED | 6 |
| COMPLETED | 0 |
| NOT COMPLETED | 6 |
Reasons for not completing this period:
| Reason | Pemetrexed |
|---|---|
| Investigator left site and no follow-up | 6 |
Analysis population for the primary outcome, as defined in the registry: Investigator no longer at site. Study was closed with no PI transfer, data collection or statistical analysis.
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 | Pemetrexed |
|---|---|---|
| Participants analysed | 6 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 6 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 54 (37 to 58) |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 3 |
| Region of Enrollment: United States | participants | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Progression Free Survival, measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
Progression-free survival is the primary endpoint. The registry record defines it as the period from the date of first study drug administration to the date a participant is determined to have progressive disease or dies from any cause. The listed timeframe is 2 years.
As a time-to-event measure, progression-free survival incorporates both whether an event occurs and when it occurs. In general, this type of endpoint can describe the timing of disease progression or death in a study population, rather than simply counting whether an event happened by a single visit. It also treats death from any cause as an event under the definition in this record.
For an interpretable time-to-event analysis, the record would need outcome and follow-up information, including event dates or suitable follow-up status for participants who had not experienced an event by the end of their observed follow-up. Those data, along with an analysis, are not reported in the registry record. The primary-outcome population field instead says the study closed without data collection or statistical analysis.
Thus, the endpoint definition tells readers what the study intended to measure, but it does not provide an estimate of progression-free survival. No event count, survival estimate, confidence interval or comparison is reported. The endpoint should be read as a planned measure, not as a result showing what occurred in the enrolled group.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record documents a Phase II, single-group study of pemetrexed for recurrent cervical adenocarcinoma and related cervical cancer. It lists enrollment of 6 and identifies progression-free survival as the primary outcome. However, it does not report an outcome estimate or statistical analysis. The record’s primary-outcome population field says the study was closed after the investigator was no longer at the site, with no principal investigator transfer, data collection or statistical analysis.
Consequently, there is no posted progression-free survival result to interpret. No number of progression or death events, time-to-event estimate, confidence interval or p-value is reported. Response rate and overall survival are named as secondary outcomes, but their results are also not reported in the registry record. An outcome definition and a planned timeframe do not substitute for collected participant data or a completed analysis.
The single-group design also limits the kind of conclusion that could be drawn even if outcomes had been analyzed. A description of outcomes among participants in one group would not make a randomized comparison. It would not establish how those outcomes differed from a control group, nor isolate the effect of pemetrexed from other factors. The registry record lists no comparator and records allocation as NA.
The enrollment count describes the registered study size, not the number of participants with evaluable outcome data. The record does not state how many participants received the intervention, completed follow-up, experienced progression or death, or contributed to any outcome analysis. Those details are not reported in the registry record. Without them, the precision and completeness of an outcome estimate cannot be assessed.
The status is terminated, and the record gives a reason related to investigator availability and the absence of data collection and analysis. This is important context, but it does not reveal what individual participants experienced. The posted information supports conclusions about the study’s planned design and documented closure, not about clinical outcomes following pemetrexed.
No conclusion about the intervention’s effect should be drawn from an absent result. Lack of a reported estimate is not evidence that an outcome did or did not occur, and it does not establish whether the intervention was beneficial or harmful. It means that the registry record does not contain analyzed outcome data with which to address the stated clinical question.
9. Statistical Methods Explained
The methods documented in the registry record are limited to the study classification, intervention description, outcomes and closure information. It is recorded as Phase II, single group, with allocation marked NA and masking listed as none. The record does not report a statistical analysis plan or completed outcome analyses. The explanations below describe general statistical concepts and do not imply that a particular analysis was conducted in this study.
What does a single-group design estimate?
In general, a single-group study can describe outcomes observed among the participants enrolled. For a time-to-event endpoint such as progression-free survival, an analysis may describe the timing of events while accounting for participants whose event status is not observed over the same period. Such a description is not a direct treatment comparison. Without a comparator group, changes or outcomes cannot be attributed to the intervention simply by observing them after treatment begins.
The registry record lists no control group. Therefore, there is no within-trial contrast between pemetrexed and another intervention. A comparison to external evidence would require a separate and carefully justified design and information about the external population; such a comparison is not reported in the registry record.
Why does a confidence interval matter?
In general, a confidence interval expresses the statistical uncertainty around an estimated quantity under the assumptions of the analysis. It helps readers distinguish a relatively precise estimate from one that is compatible with a wider range of values. A confidence interval does not correct for missing data, bias, or limitations in the study design. No progression-free survival estimate or confidence interval is reported in the registry record, so its precision cannot be assessed.
What is needed for time-to-event analysis?
In general, time-to-event methods use information about when an event occurred and how long each participant was observed. Participants without a recorded event by the end of available follow-up may be censored, meaning their later event status is unknown for the analysis. Correct interpretation depends on adequate follow-up information and appropriate handling of censoring. The record defines progression-free survival from first study drug administration to progression or death from any cause, but does not report participant event times, censoring information, or an analysis.
It is therefore not possible to determine from the registry record whether any time-to-event method was used, how follow-up was handled, or whether the planned 2 years of observation was reached for participants. These details are not reported in the registry record.
What can a reported event count tell readers?
In general, event counts provide basic information about the amount of outcome information available. A small number of observed events usually limits how much can be learned about the timing and distribution of an outcome. Counts alone do not provide a time-to-event estimate or its uncertainty. In this record, no primary-outcome event count is reported, so the amount of event information available for progression-free survival is unknown.
How should planning illustrations be understood?
General sample-size illustrations describe hypothetical requirements under specified assumptions; they are not observed trial results and do not show that a study had a particular probability of detecting an effect. The registry record’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation and an effect defined as a stated fraction of an observed effect. For time-to-event illustrations, the stated quantity is total events; for other illustrations, it is participants per arm.
These assumptions are not a description of this trial’s design: the registry classifies the study as single group and lists no control arm. The registry record does not report a sample-size justification for the trial. Nor does it report an observed primary outcome effect on which a trial-specific planning interpretation could be based. Planning calculations, where displayed, should not be interpreted as observed power or as evidence that the planned design was adequate.
Overall, the available methods information supports a description of the intended study, not a reconstruction of its analysis. The analysis plan, methods for missing outcome information, analysis populations and any interim analyses are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record names progression-free survival as the primary outcome and response rate and overall survival as secondary outcomes. It also reports 3 outcome measures, but does not provide outcome results or analyses. The record does not state whether the listed outcomes were analyzed, how outcome-specific definitions were applied beyond the primary endpoint definition, or how multiple outcome questions were handled.
In general, multiplicity arises when several outcomes or statistical tests are considered. If many tests are used, the chance of at least one apparently notable result can increase unless the analysis plan addresses that issue. Possible approaches depend on the study question and planned analysis. No multiplicity strategy is reported in the registry record, so it is not possible to determine whether any adjustment or hierarchy was planned.
The primary-outcome population field states that the investigator was no longer at the site and that the study was closed with no principal investigator transfer, data collection or statistical analysis. This means the registry record supplies no basis for evaluating missing outcome observations, follow-up completeness or exclusions from an analysis population. The number enrolled is not a substitute for the number with usable data for a particular endpoint.
In general, missing outcome information can affect both the amount of precision and the validity of an estimate. Interpretation depends on why data are missing, how much is missing and how the analysis handles it. Those details are not reported in the registry record. The analysis populations—such as whether all enrolled participants or only participants who received study drug would have been included—are also not reported. No interim analyses or stopping rules are reported either. Given the stated absence of data collection and statistical analysis, these are unresolved reporting gaps, not evidence of a particular analytic choice.
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 |
|---|---|---|---|
| Pemetrexed | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Pemetrexed | 0 of 6 |
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 |
|---|---|
| Pemetrexed | 0 of 6 |
The adverse-event record lists 6 participants at risk in the pemetrexed group for the serious-event category and 0 affected. It also lists 6 at risk for the other-event category and 0 affected. The death count is 0, and no top serious adverse-event terms are listed.
These are the counts recorded in the registry, not a detailed account of safety monitoring. The record does not provide event-level descriptions, severity grades, timing, attribution, duration, or information about how adverse events were collected. It also does not report how many participants actually received pemetrexed. The at-risk counts should therefore be read as registry counts, rather than assumed to represent a fully characterized treated population.
A recorded count of 0 affected means no affected participants are listed in that category in this record. It does not establish that no adverse events occurred or were observed during the study, particularly because the primary-outcome population field states there was no data collection or statistical analysis. The available safety counts are limited and should not be expanded into a broader conclusion about safety. Further detail is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that a Phase II, single-group study of pemetrexed was registered for people with advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the cervix. It documents the intended intervention schedule, the primary endpoint definition, the secondary outcomes, an enrollment of 6, and a terminated status. It also states that the study closed after the investigator was no longer at the site, with no principal investigator transfer, data collection or statistical analysis.
That information does not establish an outcome for any participant. There is no reported progression-free survival estimate, response rate, overall survival result, confidence interval or statistical test. The adverse-event listing contains counts, but it does not supply the event detail needed to characterize safety comprehensively. The record does not report who received study drug or what follow-up was completed.
The absence of an outcome analysis should not be interpreted as a negative result or as evidence that the intervention had no effect. It also cannot support a claim that the intervention had an effect. The appropriate statistical reading is that the registry record documents the study’s plan and closure, while the intended outcome question remains unanswered by reported analysis.
Even a complete description of outcomes in this single group would not, by itself, provide a randomized comparison. The design has no registered comparator, so it could not directly estimate a difference between pemetrexed and another treatment within this trial. Any broader comparison would require evidence and methods not reported in the registry record.
Readers can therefore use the record to understand what was planned and why the study was closed, but not to judge the magnitude or precision of a treatment effect. The distinction between a planned endpoint and a reported result is especially important when a trial has terminated without data collection or statistical analysis.
13. Why This Trial Matters Statistically
This study is statistically notable because the registry record separates a documented clinical question from an analyzed result. It specifies progression-free survival as the primary endpoint and defines the event as progression or death from any cause after first study drug administration. But it also states that the study closed without data collection or statistical analysis. That contrast makes clear why registration details alone cannot answer an outcome question.
The record also illustrates the limits of a small single-group study. Enrollment is listed as 6, and no comparator is recorded. Even if outcome data had been available, a single-group description would not provide the same evidence as a randomized comparison. A small study can also yield limited outcome information, particularly when the relevant events are few; however, the event count for progression-free survival is not reported, so the amount of information cannot be assessed.
For statistical readers, the key distinction is between design, measurement and analysis. The registry documents a planned intervention and endpoint, but it does not report the participant-level observations or analysis needed to estimate an outcome. A well-defined endpoint is essential, yet it cannot substitute for ascertainment, follow-up and a transparent analysis.
The study’s closure details also matter for interpreting missing information. The record attributes closure to the investigator no longer being at the site and says there was no principal investigator transfer, data collection or statistical analysis. This provides context for why results are unavailable, while leaving participant-level outcomes unknown. The record is therefore useful as an example of how registry documentation can identify what was intended without supplying evidence about what happened to participants.
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 is that the registry record reports no data collection or statistical analysis for the primary outcome. As a result, progression-free survival cannot be estimated, and its precision cannot be assessed. The record does not report event counts, participant follow-up, censoring information, or the number of participants with evaluable outcome data.
The study is listed as terminated, with the stated reason that the investigator was no longer at the site and no principal investigator transfer occurred. The record does not provide further details about the circumstances of closure or the outcomes of enrolled participants. Enrollment of 6 does not show how many participants received treatment or completed follow-up.
The single-group design and absence of a comparator preclude a direct within-trial treatment comparison. The record does not describe a statistical analysis plan, sample-size justification, analysis populations, handling of missing data, or interim analyses. It also does not report results for the secondary outcomes of response rate and overall survival.
Safety information is limited to participant counts by broad event category and a death count. No top serious adverse-event terms are listed, and the record does not provide event-level detail or collection methods. These gaps mean that safety findings cannot be characterized beyond the counts recorded.
Finally, the registry record’s planned outcome timeframe of 2 years does not establish that participants were followed for that duration. Follow-up completion and outcome ascertainment are not reported. The design and intervention description should therefore be treated as documentation of intent, not evidence of completed outcome evaluation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas — NCT02868892.
- Registry record last updated 2018-11-02; status last verified 2018-10.
- Results first posted 2018-11-02.
- 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
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a Phase II, single-group study of pemetrexed for advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the cervix. Enrollment is listed as 6, and the study status is terminated. The primary outcome is progression-free survival, defined from first study drug administration to progression or death from any cause, with a timeframe of 2 years. Response rate and overall survival are listed as secondary outcomes.
The intervention description specifies pemetrexed 500 mg/m2 as an intravenous infusion on an every three week schedule. The registry record states that the study closed because the investigator was no longer at the site, with no principal investigator transfer, data collection or statistical analysis. No clinical outcome analysis is reported. The recorded adverse-event counts are 0 affected in both listed categories and 0 deaths, with no top serious adverse-event terms listed.
The record documents the planned study and its closure, but does not provide analyzed efficacy outcomes or detailed safety results.