Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer (NCT01590017), a na phase 2 study. The primary outcome is Treatment Completion Rate.

2. Clinical Question

3. Trial Design

This is a phase 2, single-group study sponsored by the AIDS Malignancy Consortium. The registry marks the study as completed, with enrollment recorded as 41. Its start date is 2014-04-01 and its primary completion date is 2017-04-20. These are registry study dates; they do not give the date of each participant's treatment or follow-up.

The intervention combined cisplatin and radiation therapy. The cisplatin description specifies 40 mg/m2, with a maximum of 70 mg, administered intravenously over 30-60 minutes on days 1, 8, 15, 22, 29 and 36 for a total of 6 weekly cycles. Radiation therapy is described as taking place over 8 weeks. The external pelvic radiation description gives 41.4-45.0 Gy, delivered in 1.8 Gy per fraction over 23-25 fractions across five weeks. The registry also mentions intracavitary brachytherapy, but its arm description ends after “low dose:”; the remaining details are not reported in the registry record.

Allocation is listed as NA, masking as none, and the model as single-group. These design entries mean the registry does not describe random assignment, blinding, or a concurrent comparison arm. A single-group study can describe treatment delivery and outcomes within the enrolled group, but it does not establish how those outcomes compare with what would have occurred under another treatment or without the regimen.

The registry calls the study a feasibility study of safety, toxicity, and compliance. Its listed primary outcome is treatment completion, but no result for that outcome is reported. The record does not report a protocol, eligibility details, the basis for the enrollment target, or whether the registry enrollment corresponds to the number included in any primary-outcome analysis.

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

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.

Population: Patients who enrolled in the study

6. Primary Endpoint

The registry lists the primary outcome as Treatment Completion Rate, measured over 8 weeks.

The primary endpoint is titled “Treatment Completion Rate.” Its description says it is the number of participants who completed therapy, and the timeframe is 8 weeks. This is a count-based measure of whether participants completed the planned treatment, rather than a measure of tumor response or a comparison between treatment groups.

Completion can be relevant in a feasibility study because it describes whether participants were able to finish the regimen as specified. For a combined treatment involving scheduled chemotherapy and a course of radiation, a completion outcome can summarize treatment delivery. In general, such an endpoint is most interpretable when the definition of completion, the population assessed, and the handling of incomplete or unavailable records are clear. Those details are not reported in the registry record.

The registry gives the endpoint definition and timeframe but does not give the number of participants who completed therapy, a denominator for the outcome, or an estimate with uncertainty. Enrollment is recorded as 41, but that fact alone does not establish how many participants had an evaluable completion outcome. The primary endpoint therefore cannot be quantified from the posted results. The safety figures elsewhere in the record do not substitute for the missing completion result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical information in the registry is limited. The primary outcome is a count of participants who completed therapy, but an outcome analysis is not posted. The record lists 2 outcome measures and 0 analyses. It does not provide an estimate, a confidence interval, a p-value, or a description of a primary-outcome model. The following concepts explain how such results are generally interpreted; they do not describe analyses confirmed to have been conducted in this study.

What does a completion count represent?

In general, a count records how many participants meet a defined event criterion. For treatment completion, that requires a clear rule for what constitutes completion and an explicit population in which the count is assessed. A count alone is not a rate: interpreting it as a rate requires a denominator, and the denominator must correspond to the participants assessed for that endpoint. The registry provides the endpoint title and a timeframe of 8 weeks, but does not report the completion count, endpoint denominator, or detailed completion rule. Enrollment of 41 is a separate registry entry and should not automatically be substituted as the endpoint denominator.

Why does uncertainty matter?

In general, an observed count or proportion is an estimate from the participants assessed, not a guarantee of the outcome in every similar population. A confidence interval conveys the statistical uncertainty associated with an estimate under a specified method and assumptions. Its width depends on the amount and pattern of information available and on the analysis used. The registry does not report a completion estimate or confidence interval, so neither the observed precision nor the range of values compatible with the endpoint data can be evaluated.

What can a single-group design estimate?

In general, a single-group study can describe outcomes among participants who receive the intervention. It does not provide a randomized between-group contrast. Without a concurrent control group, differences from other populations or historical experiences may reflect differences in participant characteristics, care, outcome ascertainment, or other factors, rather than the intervention. The registered design is single-group, with allocation listed as NA and masking as none; the record does not identify a comparator. Therefore, any within-group outcome would not, by itself, estimate a causal comparative effect.

What is over-dispersion, and does it apply?

In general, over-dispersion means that observed variability in count data is greater than a statistical model expects. If a count outcome is analyzed using a model that assumes less variability than the data contain, uncertainty can be understated. Analysts may use a model that allows extra variation when the outcome and study structure justify it. This is a general consideration for count analyses, not a claim about this trial: the registry does not report a count model, a dispersion estimate, or an analysis of treatment completion. Moreover, the endpoint is described as a count of participants completing therapy, which may be handled as a binary outcome for each participant or as a group-level count, depending on the analysis plan. That plan is not reported.

How should the planning assumptions be read?

The registry describes a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. These are assumptions for an illustrative two-arm calculation, not evidence that the study had two arms or used those methods. The registered trial is single-group. The registry does not report a trial-specific sample-size justification, a planned target effect, or a statistical analysis plan. A planning sample size is not observed power; observed power is not a substitute for an effect estimate or its confidence interval.

For a two-arm illustration, equal allocation describes an assumed distribution of participants between comparison groups. It does not describe the allocation in this study, where allocation is recorded as NA and no comparator is listed. Likewise, the normal approximation is a calculation assumption, not a finding about the distribution of this endpoint. Any illustration based on an observed effect would need an effect estimate, but the primary completion result is not reported in the registry record. Thus the assumptions cannot be used to infer the trial's precision or success.

What is needed to evaluate the posted endpoint?

In general, a transparent endpoint report identifies the analyzed population, the number with the outcome, the denominator assessed, the outcome definition, and a measure of uncertainty where appropriate. It also describes how missing or incomplete endpoint information was handled and whether the analysis followed a prespecified plan. The registry record does not report these details for treatment completion. Its listed analysis count is 0, so no primary-outcome statistical analysis is available to interpret. This absence does not establish that no analysis was performed outside the registry; it means an analysis is not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Cistplatin and Radiation Therapy")
n      <- c(41)
events <- c(37)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Cistplatin and Radiation Therapy  41  37  90.2  76.9  97.3  77.5  96.1  77.4  96.0

11. Multiplicity, Missing Data and Analysis Populations

The record lists 2 outcome measures and 0 analyses. It identifies treatment completion as the primary outcome, but does not report a result for it. The other outcome measure and its analysis are not described in the available record. No multiplicity procedure, hierarchy among outcomes, or adjustment for multiple testing is reported in the registry record.

Multiplicity matters in general when several outcomes or repeated statistical tests are interpreted: testing many questions can make apparently notable findings more likely to arise by chance. A prespecified primary outcome and an analysis plan help clarify which result is intended to answer the main question. Here, the primary outcome is named, but no statistical plan or multiplicity strategy is reported. There are no posted primary-outcome tests to interpret.

The registry does not describe missing-data handling, the number with an evaluable completion outcome, or the analysis population. It does not say whether participants with incomplete follow-up, discontinuation, or unavailable records were included in a denominator or treated in a particular way. These omissions prevent assessment of whether the reported enrollment corresponds to the endpoint population. They also prevent evaluation of possible bias if endpoint information was unavailable for some participants.

In general, missingness can affect an estimate when the availability of an outcome is related to participants' outcomes or other characteristics. Methods for handling missing data depend on the outcome and the reasons information is absent. No particular missing-data method can be attributed to this study from the registry record.

12. Safety Results

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

Deaths

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: metastatic cancer of the uterine cervix (12.2%), vomiting (4.9%), thromboembolic event (4.9%), anemia (2.4%), diarrhea (2.4%).

The adverse-event record lists 41 participants at risk for serious events, with 10 affected, and 41 at risk for other events, with 39 affected. It separately records 7 deaths. These are registry safety entries; the record does not explain the observation period or the relationship between the death entry and the event categories. The figures should be read as descriptive counts, not as proof that the intervention caused the events or deaths.

The listed serious-event terms and percentages are metastatic cancer of the uterine cervix, 12.2%; vomiting, 4.9%; thromboembolic event, 4.9%; anemia, 2.4%; diarrhea, 2.4%; and Death NOS, 2.4%. The registry does not give event-level details, timing, severity grading, treatment attribution, or whether a participant could contribute to more than one term. These percentages therefore should not be added or treated as mutually exclusive categories.

General safety interpretation depends on how events were defined, collected, and attributed, as well as the period during which participants were observed. Those details are not reported in the registry record. The posted counts alone cannot establish comparative safety because the study has no control group.

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

The registry record identifies a study of cisplatin with radiation therapy in participants with HIV-associated locally advanced cervical cancer. It records treatment completion as the primary outcome and lists safety information. The primary completion result itself is not reported. As a result, the posted record does not establish how many participants completed therapy or how precisely completion was estimated.

The study's completed status and its enrollment entry of 41 are administrative and design details, not a clinical outcome. In particular, completed refers to the registry study status, not completion of the regimen by participants. The adverse-event counts and listed terms describe what the registry reports, but they do not provide a comparison group, treatment attribution, or enough information to infer a causal relationship.

In general, a single-group study can contribute descriptive information about the participants treated and the outcomes recorded in that group. Without a comparator, it cannot determine whether an observed outcome differs from what would have happened under another approach. The registry record also does not report eligibility details, participant characteristics, the primary-outcome analysis population, or missing-data methods. Those gaps limit the interpretation of any group-level description.

The registry's planning assumptions are not a finding about treatment benefit or the statistical success of the study. The two-arm equal-allocation illustration does not match the recorded single-group design, and no primary completion estimate is posted to assess. Planning calculations cannot replace observed outcome data, an uncertainty interval, or a comparative analysis.

Accordingly, the posted record supports a description of the study design, intervention schedule, primary endpoint, and selected safety entries. It does not support a numerical conclusion about treatment completion, a comparative efficacy claim, or a causal safety conclusion. Any stronger interpretation would require results and methodological details not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically notable because its stated purpose and primary endpoint concern feasibility, safety, toxicity, and compliance in a population described as having HIV-associated locally advanced cervical cancer. Treatment completion is a direct delivery outcome: it asks whether participants completed the regimen, rather than measuring a treatment-group contrast. Such outcomes can be important when a study evaluates whether a complex regimen can be delivered as intended.

The design information is essential to interpretation. The registry identifies a phase 2 single-group study with no comparator and no masking. A single-group description can be useful for documenting the experience of the enrolled participants, but it cannot distinguish an intervention effect from other influences. The safety entries therefore remain descriptive rather than comparative.

The record also illustrates why an endpoint definition is not the same as an endpoint result. Treatment completion is named and given an 8 weeks timeframe, but its count, denominator, and analysis are absent. Without those pieces, readers cannot assess the observed completion pattern or its uncertainty. The enrollment entry does not fill that gap because the record does not state the endpoint analysis population.

Finally, the registry's planning illustration assumes equal allocation between two arms, whereas the registered study is single-group. Recognizing that mismatch prevents a planning scenario from being mistaken for a description of the actual trial design or its statistical power. The record's value lies in making the design and reporting gaps visible as well as identifying the outcomes and safety entries it does contain.

15. 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 primary limitation for interpreting this trial from the registry record is the absence of a reported result for treatment completion. The record gives the endpoint title, description, and timeframe but not the completion count, denominator, estimate, or uncertainty. It also records 0 analyses, so no primary-outcome statistical result is available there.

The single-group design has no concurrent comparator. Allocation is listed as NA and masking as none. This prevents a direct comparative interpretation and limits causal conclusions, including for safety. The registry safety entries do not include the timing, attribution, event-level detail, or observation period needed to place them in fuller context.

Important methods are not reported in the registry record: eligibility criteria in detail, participant characteristics, the primary-outcome analysis population, missing-data handling, the statistical analysis plan, multiplicity methods, and the study's sample-size justification. The registry's stated sample-size assumptions describe a two-arm planning illustration, not the registered single-group design. The record also does not provide the result needed to evaluate any such illustration against an observed completion effect.

The arm description is incomplete. It specifies cisplatin and aspects of external pelvic radiation, then begins a description of intracavitary brachytherapy that ends after “low dose:”. Further treatment details are not reported in the registry record. These reporting limitations mean that the intervention cannot be fully reconstructed from this entry and that the endpoint and safety information should be interpreted only as posted, without filling in the missing details.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer — NCT01590017.
• Registry record last updated 2022-07-27; status last verified 2019-07.
• Results first posted 2019-08-07.
• 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.

19. Record Summary

NCT01590017 is a completed phase 2, single-group study sponsored by the AIDS Malignancy Consortium. It concerns cisplatin with radiation therapy for HIV-associated locally advanced cervical cancer. Enrollment is recorded as 41; the study start date is 2014-04-01 and the primary completion date is 2017-04-20.

The primary outcome is treatment completion, described as the number of participants who completed therapy within 8 weeks. The registry record does not report its result or an analysis. Safety entries list 10 participants affected by serious events among 41 at risk, 39 affected by other events among 41 at risk, and 7 deaths, along with selected serious-event terms and percentages. The single-group design provides no control comparison, and important analysis and safety details are not reported in the registry record.