Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma (NCT00582205), a na phase 2 study. The primary outcome is Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy..

2. Clinical Question

The trial was framed as a feasibility evaluation: the primary endpoint counts participants who could receive the specified course of intraperitoneal cisplatin. This is a question about treatment delivery, rather than a randomized comparison of competing approaches. The registry record does not report the observed count for this endpoint, so it does not show how many participants met the completion criterion.

The official title includes Stage IA, IB, IC, II, III, IV and recurrent platinum-sensitive ovarian, fallopian tube, and primary peritoneal carcinoma, as well as Stage III and IV uterine cancer. The brief description is broader in wording and describes chemotherapy given directly into the abdomen along with intravenous administration. The recorded intervention is named Paclitaxel, Cisplatin IP. Further details about how treatment was administered are not reported in the registry record.

There is no like-for-like control comparison from which to estimate a relative treatment effect. The registry record instead describes a single treatment group and an endpoint concerning the ability to receive 6 cycles. It also lists a secondary outcome concerning dose reductions or delays due to neuropathy or toxicity. The observed result for that secondary outcome is not reported in the registry record.

3. Trial Design

This is a phase 2, single-group trial sponsored by the University of Oklahoma. The registry record lists enrollment of 21 participants and a status of terminated. The recorded start is 2006-01, and primary completion is listed as 2011-12. The registry record does not explain the reason for termination.

The study has a single arm named Paclitaxel, Cisplatin IP. Its description identifies participants receiving intraperitoneal chemotherapy. Allocation is listed as not applicable, and masking is listed as none. There is no separate control arm, so the design does not support a randomized, between-group comparison. The trial title and description concern feasibility of chemotherapy delivered into the abdomen, with the brief summary also referring to intravenous administration.

The primary outcome is the number of participants able to receive 6 cycles of intraperitoneal cisplatin chemotherapy, with a timeframe of 3 years. The secondary outcome concerns the number of patients with dose reductions or dose delays due to neuropathy or toxicity. The registry record lists 2 outcome measures, but does not report the primary endpoint count or the result for the secondary outcome. It lists no outcome analyses.

Because there is no comparator, any observed count would describe outcomes among participants in this treatment group. It would not, by itself, identify what would have happened under a different treatment or without intraperitoneal administration. A single-group feasibility design can describe whether participants received the intended treatment course and can document recorded adverse events. It cannot separate the effects of treatment from other factors that may influence completion or safety outcomes.

The registry record does not report eligibility criteria beyond the cancer types and stages summarized in the title, the protocol’s treatment schedule, or details of the intravenous treatment. It also does not report the reason for the enrollment target or whether recruitment stopped as planned. These omissions limit what can be concluded about how the enrolled group was selected and how closely the recorded study conduct followed an intended protocol.

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

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 Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy., measured over 3 years.

The primary endpoint is the number of participants able to receive 6 cycles of intraperitoneal cisplatin chemotherapy. It is a count of participants meeting a treatment-completion criterion, not a measurement of tumor response, survival, or symptom change. The specified timeframe is 3 years.

A completion endpoint is relevant to a feasibility question because it describes whether participants were able to receive the planned treatment course. In general, such an endpoint can reflect practical aspects of treatment delivery, including whether treatment can be continued through the intended number of cycles. It does not, on its own, explain why a participant did or did not complete treatment. Reasons might require separate records, such as discontinuation details or toxicity data, and those details are not reported in the registry record.

The outcome is defined as a count, but the registry record does not report the count achieved. It therefore does not establish how many participants completed 6 cycles, nor does it provide an estimate of the frequency of completion. Without a reported result, the endpoint’s precision cannot be assessed. The meaning of the endpoint is also bounded by its specific definition: receiving 6 cycles is not interchangeable with completing another treatment schedule or meeting a clinical efficacy endpoint.

The registry record lists dose reductions or delays due to neuropathy or toxicity as a secondary outcome. That outcome could provide different information about treatment delivery and tolerability, but its result is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design and outcome definitions determine what statistical conclusions can be drawn. This trial is recorded as a phase 2 single-group study, with a single treatment arm and no masking. The primary endpoint is a participant count. No outcome analyses are listed in the registry record, so statistical methods used to analyze the primary endpoint are not reported.

What does a single-group design estimate?

In general, a single-group study can describe outcomes among the participants who received the intervention. For a binary completion outcome, an analysis might report the number who met the criterion and the proportion of the analyzed group who did so. The registry record identifies the endpoint as a count, but does not report its observed value or an analyzed proportion. Therefore, no completion frequency can be stated from this record.

A single-group estimate is not a treatment contrast. Without a concurrent comparator, it cannot show whether completion or an adverse event would have been more or less common under another treatment. Participants may differ in disease characteristics, prior treatment, or other factors that could influence whether they receive the full course. The registry record does not report enough participant-level information to assess such factors.

What does a binary outcome mean?

In general, a binary outcome classifies each participant into one of two categories for the defined measure. For the primary endpoint, those categories would correspond to meeting or not meeting the criterion of receiving 6 cycles, provided the outcome is recorded for each participant. A count of participants in one category can be useful for a feasibility question because it directly addresses the number reaching the stated treatment milestone. It does not describe the timing of interruptions or the reasons for not reaching that milestone.

When a binary outcome is analyzed using a binomial model, the model relates the number of participants with the event to the number contributing data. Such an analysis relies on assumptions about how outcomes are recorded and how observations relate to one another. This is a general description of a possible approach, not a claim that the trial used that model. The statistical model, any estimate of completion frequency, and any uncertainty interval are not reported in the registry record.

Why does precision matter?

In general, an estimate is more informative when accompanied by an uncertainty interval. An interval reflects sampling variability under the chosen method and assumptions; it does not remove possible bias or make a single-group result comparable to a randomized contrast. The registry record does not report an interval for the primary endpoint, so the precision of the completion result cannot be evaluated. Enrollment alone is not enough to reconstruct that precision because the endpoint count and analysis details are absent.

For a small study, descriptive estimates can be imprecise, especially when few participants experience an outcome. This general consideration is relevant to interpretation of any count from a limited enrollment, but it does not supply a missing result or quantify uncertainty for this trial. No interval should be inferred from the enrollment total without the endpoint data and a specified method.

What can the safety counts show?

The record lists participants at risk and participants affected for serious and other adverse events. These counts are descriptive. They identify the number recorded in each category but do not provide exposure-adjusted rates or a comparison with an untreated or alternative-treatment group. The registry record does not report event onset, duration, recurrence, severity grading beyond the serious-event distinction, or how event attribution was determined.

In general, serious adverse events and other adverse events are different reporting categories, and a participant may experience more than one event. Participant counts in separate categories therefore should not automatically be added. The registry record does not specify whether the affected counts refer to unique participants across categories or how overlapping events were handled. The top serious term, small bowel obstruction, is listed with a frequency of 4.8%; that entry should be read as reported, without assuming a denominator or translating it into a different measure.

What statistical plan is documented?

The registry record lists 2 outcome measures and no analyses. It does not report a planned statistical model, hypothesis test, significance threshold, confidence-interval method, covariate adjustment, interim analysis, or missing-data procedure. It also does not report a sample-size justification. These matters should be treated as undocumented rather than inferred from common practice or from the phase designation. The record’s endpoint definition and enrollment figure alone do not reveal which methods were planned or used.

In general, multiplicity refers to the challenge of interpreting several statistical tests or endpoints together. A study may address multiplicity through its endpoint hierarchy or a prespecified adjustment strategy, but neither is described in the registry record. Since no analyses are listed, there are no reported test results on which to assess multiplicity handling. Likewise, no conclusion about the statistical significance of an outcome is supported by the registry information.

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("Paclitaxel, Cisplatin IP")
n      <- c(21)
events <- c(7)
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  Paclitaxel, Cisplatin IP  21  7  33.3  14.6  57.0  17.2  54.6  17.2  54.9

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 2 outcome measures: the primary count of participants able to receive 6 cycles of intraperitoneal cisplatin chemotherapy, and a secondary measure concerning dose reductions or dose delays due to neuropathy or toxicity. It lists no analyses. No statistical testing plan, endpoint hierarchy beyond the primary and secondary labels, or approach to multiplicity is reported. In general, multiplicity arises when several outcomes or hypotheses are evaluated, because interpreting multiple tests can affect the chance of a misleading positive finding. No adjustment or other strategy should be attributed to this trial without documentation.

The primary endpoint result and the secondary outcome result are not reported in the registry record. The record also does not report whether outcome data were missing, how missingness was defined, or how incomplete data were handled. It does not identify an intention-to-treat, per-protocol, safety, or other analysis population. Enrollment of 21 should therefore not be treated as evidence that 21 participants contributed to each endpoint analysis.

In general, missing outcome data can affect an estimate if participants with unavailable outcomes differ from those with recorded outcomes. A complete-case analysis, an imputation method, or another approach may yield different estimates, depending on the circumstances and assumptions. None can be attributed to this study from the registry record. Without the number of participants assessed for each outcome and a description of missing-data handling, the extent to which missingness could influence results cannot be assessed.

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 1% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: small bowel obstruction (4.8%).

The registry lists 21 participants at risk for serious adverse events, with 1 affected. It separately lists 21 at risk for other adverse events, with 6 affected, and records 0 deaths. The top serious adverse event term is small bowel obstruction, listed at 4.8%. These are the recorded safety figures for the single treatment group.

The counts should be read as descriptive registry entries, not as a comparison of treatment risks. There is no separate control group, and the record does not report a rate adjusted for treatment exposure or follow-up duration. The serious and other adverse event categories are reported separately; the registry record does not clarify whether a participant affected in one category could also be counted in the other. The counts should not be added together to create a total number of affected participants.

The term frequency of 4.8% should be read as reported. The registry record does not specify the denominator used for that percentage in the information, so it should not be reinterpreted as a particular participant-level risk. The record also does not provide event timing, recurrence, duration, severity grades beyond the serious classification, or detailed attribution. These omissions limit comparisons and prevent a fuller assessment of the pattern of adverse events.

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

The trial addresses a practical feasibility question: how many participants could receive 6 cycles of intraperitoneal cisplatin chemotherapy. The registry record identifies that endpoint but does not report its result. It therefore does not establish the number who completed the specified course or the proportion of enrolled participants who did so. The secondary outcome concerning dose reductions or delays is also not reported.

The safety entries document 1 participant affected by a serious adverse event among 21 listed at risk, 6 affected by other adverse events among 21 at risk, and 0 deaths. Small bowel obstruction is listed among the top serious terms at 4.8%. Those entries describe the recorded experience in the treatment group; they are not estimates of a comparative effect. Without a control group, the information cannot show whether the event counts would differ under another treatment.

In general, feasibility and safety descriptions can inform understanding of treatment delivery, but they do not answer every clinical question. Receiving the intended number of cycles is distinct from demonstrating tumor control or survival benefit. The registry record does not report efficacy outcomes, and no efficacy conclusion follows from the listed feasibility endpoint or adverse event counts.

The status is terminated, but the registry record does not give the reason. Termination should not be interpreted as proof that treatment was feasible, infeasible, safe, unsafe, effective, or ineffective. The record also does not provide the analysis methods, outcome completeness, or confidence intervals needed to judge precision. The appropriate interpretation is limited to the documented design, endpoint definition, enrollment, and selected safety counts, with the principal outcome result remaining unreported.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of how a feasibility question differs from a comparative treatment question. Its primary endpoint focuses on whether participants could receive 6 cycles of intraperitoneal cisplatin chemotherapy. That outcome concerns delivery of a treatment course, while the single-group design means there is no randomized comparator for estimating a relative effect.

The registry record also illustrates why an endpoint definition is not a substitute for a reported result. A clearly named completion count tells readers what the study intended to measure, but without the observed count and the number assessed, readers cannot determine how often the completion criterion was met. Nor can they evaluate the estimate’s precision. Enrollment of 21 alone cannot fill that gap.

The safety entries show another important distinction: counts from a single group are descriptive, not comparative. The record lists serious and other adverse events separately and reports a serious-event term frequency. Interpreting these entries requires attention to their denominators, possible overlap, follow-up, and event definitions. Several of those details are not reported in the registry record.

Finally, the listing of 2 outcome measures alongside no analyses highlights the importance of transparent reporting of analysis methods and results. Without those details, readers cannot assess uncertainty, missing-data handling, multiplicity, or whether the analysis followed a prespecified plan. These limits do not erase the design and safety information that is recorded, but they constrain the conclusions that can responsibly be drawn from it.

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 interpretation is that the registry record does not report the primary endpoint result. The number of participants able to receive 6 cycles is therefore unknown from this record, despite the endpoint being clearly named. The result for the secondary outcome on dose reductions or delays is also not reported, and no outcome analyses are listed.

The single-group design has no comparator, so the trial cannot provide a direct estimate of how outcomes differ from another treatment group. The registry record also does not report the reason the study was terminated. That status alone does not explain whether the trial ended because of recruitment, treatment delivery, safety, or another circumstance.

Information needed to assess the analyzed population and completeness is not reported in the registry record. The number of participants assessed for each outcome, exclusions, missing-data methods, and follow-up completeness are not given. Nor are the statistical model, uncertainty intervals, analysis plan, or sample-size justification reported. The enrollment figure of 21 cannot establish the effective sample size for an endpoint analysis.

The safety reporting is limited to selected counts and a listed serious-event term. Event timing, recurrence, duration, detailed severity, exposure duration, and attribution procedures are not reported. The registry record does not clarify possible overlap between participants counted for serious and other adverse events. The listed 4.8% for small bowel obstruction should not be expanded into a different risk measure without further denominator information.

The official title describes several cancer types and stages, but the registry information does not give detailed eligibility criteria or participant characteristics. The enrolled group’s clinical composition and the applicability of its outcomes to particular subgroups therefore cannot be assessed.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma — NCT00582205.
• Registry record last updated 2021-05-19; status last verified 2021-04.
• Results first posted 2017-05-18.
• 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

NCT00582205 is a phase 2, single-group feasibility trial sponsored by the University of Oklahoma. The registry lists enrollment of 21, status as terminated, a start of 2006-01, and primary completion of 2011-12. The intervention is named Paclitaxel, Cisplatin IP; the record describes intraperitoneal chemotherapy alongside intravenous administration.

The primary endpoint is the number of participants able to receive 6 cycles of intraperitoneal cisplatin chemotherapy within 3 years. The registry record does not report that endpoint result or the secondary outcome result, and it lists no analyses. Safety entries list 1 serious adverse event affected among 21 at risk, 6 other adverse events affected among 21 at risk, and 0 deaths. Small bowel obstruction is listed among the top serious terms at 4.8%. The reason for termination and the statistical analysis plan are not reported in the registry record.