Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix (NCT00003377), a na phase 1 study. The primary outcome is Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment.

2. Clinical Question

3. Trial Design

The registry classifies the study as phase I, with a single-group model, no masking, and allocation marked not applicable. Its official title describes a phase I study of extended-field radiation therapy with concurrent paclitaxel and cisplatin in patients with cervical carcinoma metastatic to para-aortic lymph nodes. The brief purpose also refers to phase I/II aims, including studying side effects and paclitaxel dose. These descriptions indicate a dose and safety focus; they do not establish that a later-phase efficacy comparison was conducted.

The intervention list names cisplatin, paclitaxel, radiation therapy, and brachytherapy. The listed arm description is “Radiation therapy plus concurrent weekly chemotherapy,” but no detailed dose schedule or treatment-level assignment information is included in the record. The registry lists enrollment of 29. It records a start of 1999-11, primary completion of 2009-07, and completed status.

Safety information is presented under five arm labels: Arm 1, P I; Arm 2, P I; Arm 3, P I; Arm 4, P I; and Arm 2, P II. Those labels do not make the study a randomized comparison. The record explicitly identifies the study as not randomized, and the group structure should not be read as equivalent to treatment and control groups. The registry does not explain the relationship between these safety groups, enrollment, or treatment dose levels.

The listed secondary outcomes are disease-free survival at 2 years and overall survival at 2 years. Their names identify outcomes of interest, but the record does not provide corresponding outcome results or analyses. The primary endpoint is a toxicity or significant dose-delay measure assessed after six cycles, with a timeframe of up to 21 weeks. No treatment-effect estimate, confidence interval, or statistical test for that endpoint is 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.

Before assignment: All patients received whole pelvic and extended field radiation at 150 centigray per day for 30 days to the para-aortics, and 180 centigray per day for 25 days to the pelvis.

Period I

Reasons for not completing this period:

Period II

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment, measured over up to 21 weeks.

The primary endpoint combines dose-limiting toxicity with significant dose delay of paclitaxel given with cisplatin. It is assessed using CTC 2.0 after six cycles of treatment, with a stated timeframe of up to 21 weeks. The registry expresses the measure in participants and identifies it as a number, but does not give a definition of dose-limiting toxicity, explain what qualifies as a significant delay, or report how the two components were combined.

In general, a safety endpoint of this kind is relevant in a phase I study because it captures whether treatment-related toxicity or treatment delivery becomes a concern during the planned course. A dose delay can reflect difficulty maintaining the intended schedule, while a toxicity measure records an adverse effect meeting the study's specified criteria. Those are related but not identical events, so interpretation depends on the protocol definitions and rules for classifying participants. Those rules are not reported in the registry record.

The endpoint description identifies a treatment milestone and assessment framework, but not an observed result. No number of participants meeting the endpoint, denominator for the primary analysis, or estimate of its frequency is included. The endpoint therefore describes the study question; it does not show what the study found about toxicity or delays.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The central statistical distinction is between a study question and a reported result. The registry defines a primary safety endpoint, but it does not include a primary-endpoint count or estimate. Naming an endpoint does not show how many participants experienced it. Without the event count and analysis denominator, its observed frequency cannot be described, and without an uncertainty estimate its precision cannot be assessed.

What does a participant count represent?

For a binary endpoint, each participant is classified according to whether the event or endpoint occurred under the study's definition. A count alone needs a denominator: the number of participants evaluated for that endpoint. The resulting proportion describes the observed frequency in that analysis population. It does not automatically describe the frequency in all enrolled participants, because some participants may not have been assessed or may have had incomplete data. The record does not report the primary endpoint's count, denominator, or analysis population.

The primary endpoint combines dose-limiting toxicity and significant dose delay. In general, when an endpoint combines more than one event type, its interpretation depends on the rule for considering a participant to have met the endpoint. A participant might experience one component, both components, or neither; the method must specify how those possibilities are counted. The registry title does not supply those classification details. It identifies CTC 2.0 as the assessment basis and says the endpoint is assessed after six cycles, but operational definitions and handling of incomplete treatment are not reported in the registry record.

Why would uncertainty matter?

A confidence interval is a range of values compatible with the observed data under a statistical model. It communicates how much uncertainty remains around an estimate; it is not a guarantee that the true value lies within that particular interval. For a participant proportion, interval width depends on the amount of information and the number of observed events, among other factors. Small groups can yield imprecise estimates even when a percentage appears simple to read. No confidence interval for the primary endpoint is reported, so its precision cannot be evaluated.

A p-value, when reported, assesses how compatible data are with a specified null model under the test's assumptions. It does not give the probability that a treatment works, and it does not measure the size or clinical importance of an effect. The record reports no primary-endpoint analysis or p-value. There is therefore no basis for describing the primary outcome as statistically significant or not statistically significant.

How should the safety groups be interpreted?

The listed serious and other adverse-event counts are descriptive summaries arranged by arm label. The registry identifies the overall study model as single group and allocation as not applicable. The presence of several labels does not establish random assignment, comparable groups, or a causal contrast. In a nonrandomized setting, group differences may reflect factors other than the treatment feature a reader is tempted to compare. The registry does not state what the labels represent beyond their names or explain how participants entered each group.

For the serious-event counts, the denominators are the participants listed at risk in each group. The counts should be read as group-specific observations, not as a controlled estimate of excess risk. The record's top serious-event terms are accompanied by percentages, but does not connect each term to a specific arm. These percentages should not be used to reconstruct group-level rates or event counts. The record also does not state whether a participant with multiple events contributes to multiple terms, or provide the event-level timing and duration needed for a fuller safety analysis.

What do planning assumptions mean?

In general, a sample-size calculation is a planning exercise: it asks how much information a future study might need under chosen assumptions about an effect, significance level, allocation, and statistical model. Changing those assumptions can change the resulting sample-size illustration. The record states assumptions of a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; it also describes the effect as a stated fraction of the observed effect. Such calculations are illustrations, not observed power. They do not indicate that the study had a particular probability of detecting an effect after the data were collected.

The calculation notes distinguish participant-per-arm planning for non-time-to-event outcomes from total-event planning for time-to-event outcomes using the Schoenfeld method. These are general planning conventions, not outcomes of this single-group phase I study. No randomized comparison is described, and the posted information does not provide numerical planning results to interpret. The registry also does not report the original sample-size justification or whether any planning calculation was part of the trial's design.

For survival outcomes, methods generally account for both event occurrence and follow-up time; a fixed-time outcome such as disease-free survival at 2 years requires a clear definition of the time origin, event, censoring, and analysis population. Those methodological details are not included. The record names disease-free and overall survival at 2 years but provides no estimates, follow-up summaries, censoring information, or analysis methods. Accordingly, no survival-curve shape, hazard ratio, or fixed-time probability can be inferred.

10. Multiplicity, Missing Data and Analysis Populations

The record lists one primary endpoint and two secondary outcomes: disease-free survival at 2 years and overall survival at 2 years. It does not report how the analysis addressed the possibility of multiple outcome tests. In general, evaluating several outcomes can increase the chance of at least one apparently unusual result when each is assessed separately. A prespecified hierarchy or multiplicity adjustment can address that concern, but neither is reported in the registry record. No outcome analysis results are given, so the consequences of multiplicity cannot be evaluated.

Missing-data methods are not reported in the registry record. The information does not describe how participants who did not complete six cycles, missed an assessment, or lacked outcome follow-up were handled. It also does not state whether incomplete observations were excluded, imputed, or included under another rule. These details matter because the analysis population and assumptions about missingness affect how an estimate should be interpreted.

The analysis populations are not reported in the registry record. Although enrollment is recorded as 29 and safety denominators are listed by group, the record does not state which participants contributed to the primary endpoint or secondary outcomes, or how the populations were defined. The number of outcome measures is listed as 3, while the number of analyses is 0. This does not establish that no analyses were conducted; it means that no analyses are posted in the registry record. A statistical analysis plan, interim-analysis plan, and rules for censoring or handling protocol deviations are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pulmonary disorders (33.3%), nausea and vomiting (33.3%), hypomagnesia (33.3%), diarrhea (5.9%), hypocalcemia (5.9%).

The safety record lists serious adverse-event counts by labeled group. The counts are 0 of 3 for Arm 1, P I; 0 of 3 for Arm 2, P I; 1 of 3 for Arm 3, P I; 2 of 3 for Arm 4, P I; and 1 of 17 for Arm 2, P II. The listed counts in the other adverse-event category are 3 of 3, 3 of 3, 3 of 3, 2 of 3, and 15 of 17, respectively. These figures describe the posted group-level counts, not comparisons between randomized groups.

The serious-event terms with listed percentages are pulmonary disorders, nausea and vomiting, and hypomagnesia at 33.3% each; diarrhea and hypocalcemia are listed at 5.9% each. The registry does not map those terms to individual groups or describe whether participants could appear under more than one term. The figures therefore do not support reconstructing arm-specific rates or the number of unique participants with events. The safety listing is not a complete account of event severity, timing, duration, or relationship to treatment, and should not be interpreted as a causal comparison.

12. What the Result Does, and Does Not, Mean

The registry record describes a phase I investigation focused on radiation therapy with paclitaxel and cisplatin for cervical cancer metastatic to para-aortic lymph nodes. The primary endpoint asks about dose-limiting toxicity or significant paclitaxel dose delay after six cycles, assessed using CTC 2.0 over up to 21 weeks. This conveys the safety question the study set out to examine.

The posted information does not include the primary-endpoint result. It therefore cannot establish how often participants met that endpoint or how precisely its frequency was estimated. The secondary outcome names do not substitute for results: no disease-free survival or overall survival estimates at 2 years are reported. The available safety counts provide descriptive information by group, but the nonrandomized, single-group design does not support treating differences between labels as causal effects.

These omissions do not show that an outcome was absent, nor do they show that the study found no effect. They mean the relevant estimates are not available in the registry record. Likewise, the listed adverse-event counts do not by themselves establish whether events were caused by treatment or how their frequency compares with another treatment strategy. The record does not provide a comparator group for that purpose.

Interpretation is also limited by missing information about dose levels, endpoint definitions, analysis populations, missing observations, follow-up, and statistical methods. The study's registry status is completed, but completion status is not a substitute for outcome reporting. The most defensible reading is that the registry identifies the study's clinical and safety aims and provides selected adverse-event counts, while leaving the primary endpoint and secondary outcome results unreported.

13. Why This Trial Matters Statistically

This study illustrates why the design and outcome definition must be read before interpreting a clinical statistic. A phase I study centered on toxicity and dose delay asks a different question from a randomized efficacy trial. The primary endpoint is about safety and treatment delivery after six cycles, not a direct estimate of benefit relative to a control strategy. That distinction determines what the design can support.

The registry's single-group model and allocation marked not applicable matter when interpreting the multiple safety labels. Grouped counts may look comparable at first glance, but the record does not establish random allocation, common treatment conditions, or a control arm. A numerical contrast between groups would not isolate a treatment effect. The labels and counts can be reported descriptively, with their design limitations kept explicit.

The record also demonstrates that endpoint names are not outcome estimates. Disease-free survival at 2 years and overall survival at 2 years are listed, but no corresponding results are posted. The primary endpoint is specified, but its event count and analysis are absent. Statistical interpretation requires both a defined outcome and the observations used to estimate it; the endpoint label alone cannot supply the latter.

Finally, safety counts require context about denominators, event definitions, overlap, and analysis populations. The registry offers some group denominators and event counts, but not enough detail to explain the group structure or calculate a controlled comparison. Careful reporting separates what is documented from what remains unknown. That discipline prevents descriptive safety information from being mistaken for proof of comparative effectiveness or a complete account of the trial.

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 registry record leaves important design and analysis details unspecified. It does not report eligibility criteria beyond the disease description in the study title, participant characteristics, the exact treatment schedule, or the paclitaxel dose levels. It also does not explain how participants were assigned to the several safety labels, or how those labels relate to the broad arm description. The enrollment figure and group-level safety denominators cannot be reconciled from the information reported, and should not be combined into an inferred total.

The primary endpoint lacks an observed count, denominator, and analysis estimate. The record does not define dose-limiting toxicity or significant dose delay in detail, describe how the combined endpoint was classified, or specify what happened when a participant did not complete six cycles. Although CTC 2.0 is named, the record does not provide its operational use in this study. These gaps prevent assessment of the endpoint's frequency and precision.

For secondary outcomes, the registry lists disease-free survival and overall survival at 2 years but does not report estimates, follow-up, event definitions, censoring, or analytic methods. The analysis populations, missing-data methods, multiplicity approach, and statistical analysis plan are not reported in the registry record. No interim analyses or sample-size justification are reported in the registry record.

The safety summaries are limited to grouped counts and a short list of serious-event terms with percentages. The record does not specify event-level overlap, duration, timing, attribution, or the arm membership of the listed terms. Given the single-group model and nonrandomized design, these counts cannot establish comparative treatment effects. They are selected descriptive safety information rather than a complete account of study outcomes.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix — NCT00003377.
• Registry record last updated 2013-02-04; status last verified 2012-12.
• Results first posted 2013-02-04.
• 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.

18. Record Summary

The registry describes a completed phase I, single-group study of extended-field radiation therapy with concurrent paclitaxel and cisplatin for cervical carcinoma metastatic to para-aortic lymph nodes. It records enrollment of 29 and lists radiation therapy, brachytherapy, paclitaxel, and cisplatin. The primary endpoint is dose-limiting toxicity or significant paclitaxel dose delay after six cycles, assessed using CTC 2.0, with a timeframe of up to 21 weeks.

Secondary outcomes are disease-free survival at 2 years and overall survival at 2 years. The registry includes group-level serious and other adverse-event counts and a short list of serious-event terms. It does not report the primary-endpoint result, secondary outcome estimates, or statistical analyses. The record also does not explain the relationship among safety groups or report key analysis details, including analysis populations and missing-data methods. The available information supports describing study aims and selected safety counts, but not estimating treatment effects.