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 Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer (NCT01199263), a randomized phase 2 study. The primary outcome is Progression-free Survival (PFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01199263 |
| Phase | Phase 2 |
| Condition | Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 108 |
| Arms in the primary outcome | 2 |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled patients with recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer. The primary endpoint population is described as enrolled patients. The record lists 108 participants in total, with 54 participants in each treatment arm for the posted progression-free survival and tumor-response results.
Intervention
The experimental regimen combined paclitaxel with wild-type reovirus, also called pelareorep in the intervention list. Paclitaxel was given intravenously over 1 hour on days 1, 8, and 15. Reovirus was given intravenously over 1 hour on days 1 through 5. The trial was randomized and open label.
Comparator
The comparator was weekly paclitaxel alone, given intravenously over 1 hour on days 1, 8, and 15. The record describes a parallel-group design, so participants were assigned to one of the two treatment regimens. It does not report details of the randomization procedure or allocation concealment.
Primary question
The primary question was whether the two treatment groups differed in progression-free survival, measured as time from patient entry until progression, death, or the date last seen. Progression was defined using RECIST v1.1 criteria. The posted primary results give a median and 95% confidence interval for each group, but a sponsor-reported hazard ratio or other formal between-group analysis is not reported in the registry record.
3. Trial Design
This was a randomized, open-label, parallel-group phase II trial sponsored by the National Cancer Institute. It compared weekly paclitaxel with the same paclitaxel regimen plus wild-type reovirus in patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer. The registry record lists an enrollment of 108. The posted primary endpoint results include 54 participants in each arm.
In the paclitaxel arm, treatment was given intravenously over 1 hour on days 1, 8, and 15. In the combination arm, paclitaxel was given on the same schedule, with wild-type reovirus administered intravenously over 1 hour on days 1 through 5. The trial was not masked. Details about the randomization sequence, allocation concealment, treatment adherence, or permitted subsequent treatment are not reported in the registry record.
The primary outcome was progression-free survival, with a stated timeframe of approximately 4.5 years. The registry also lists tumor response by RECIST and by CA125, as well as median overall survival, among the secondary outcomes. Results are posted for the two tumor-response outcomes, but an overall-survival result is not included in the reported secondary results. The record describes laboratory biomarker analysis as an intervention, but additional details about its role or results are not reported in the registry record.
The study is marked completed. Its listed start date is 2010-12-06, and its primary completion date is 2015-06-01. These design details establish the comparison and follow-up context; they do not, by themselves, establish how the analysis was planned or which participants were included in each 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
| Stage | Arm I (Paclitaxel) | Arm II (Paclitaxel and Wild-type Reovirus) |
|---|---|---|
| STARTED | 54 | 54 |
| COMPLETED | 48 | 52 |
| NOT COMPLETED | 6 | 2 |
Reasons for not completing this period:
| Reason | Arm I (Paclitaxel) | Arm II (Paclitaxel and Wild-type Reovirus) |
|---|---|---|
| Ineligible | 0 | 2 |
| Never Treated | 6 | 0 |
Analysis population for the primary outcome, as defined in the registry: Enrolled patients
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: All Enrolled participants
| Characteristic | Unit | Arm I (Paclitaxel) | Arm II (Paclitaxel and Wild-type Reovirus) | Total |
|---|---|---|---|---|
| Participants analysed | 54 | 54 | 108 | |
| Age, Customized: 30-39 years | Participants | 1 | 0 | 1 |
| Age, Customized: 40-49 years | Participants | 4 | 4 | 8 |
| Age, Customized: 50-59 years | Participants | 19 | 11 | 30 |
| Age, Customized: 60-69 years | Participants | 20 | 26 | 46 |
| Age, Customized: 70-79 years | Participants | 9 | 11 | 20 |
| Age, Customized: >=80 years | Participants | 1 | 2 | 3 |
| Sex: Female, Male: Female | Participants | 54 | 54 | 108 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 0 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 51 | 50 | 101 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 4 | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): White | Participants | 50 | 48 | 98 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival (PFS), measured over Approximately 4.5 years..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival measures the time from patient entry until progression, death, or the date last seen. Progression was defined using RECIST v1.1: a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. The registry identifies enrolled patients as the endpoint population and gives a timeframe of approximately 4.5 years.
Time-to-event outcomes are useful when the timing of an event matters and participants may be followed for different lengths of time. A median summarizes the time by which half of the observed event-time distribution has been reached, subject to the analysis method and available follow-up. It is not a mean and does not describe every participant’s experience. A confidence interval communicates uncertainty around the estimated median; a wide interval indicates less precision than a narrow one.
The registry posts a median and 95% confidence interval for each arm. It does not report a sponsor-derived hazard ratio, a formal comparison of the groups, or the method used to estimate the medians and their intervals. The endpoint definition and arm summaries therefore describe the outcome, but do not alone establish a treatment-group difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted median progression-free survival is 3.94 months in the paclitaxel arm, with a 95% confidence interval from 2.86 to 7.89 months. In the paclitaxel-plus-reovirus arm, the median is 4.39 months, with a 95% confidence interval from 2.6 to 5.52 months. These are descriptive arm-level estimates. The intervals are broad and overlap, and the registry does not report a sponsor-derived hazard ratio or formal statistical comparison for this endpoint.
A median comparison alone does not account for the full pattern of event times or follow-up. A hazard ratio, when reported, can summarize a relative event rate over follow-up under its model assumptions; no such sponsor-reported estimate is included in the registry record. A p-value for the primary endpoint is also not reported. The posted results therefore do not establish whether the observed median difference is distinguishable from chance variation, and they do not support a conclusion about treatment effect.
The secondary tumor-response summaries also do not show a consistent direction across measures. For RECIST response, the posted percentages are 16.7% with paclitaxel and 13.0% with the combination; the unadjusted recalculated risk difference is -0.037, with a confidence interval that crosses zero, and the unadjusted p-value is 0.588. For CA125 response, the percentages are 18.5% and 22.2%, respectively; the unadjusted recalculated risk difference is 0.037, its confidence interval crosses zero, and the unadjusted p-value is 0.633. These are unadjusted calculations, not sponsor-reported analyses. The sponsor’s own analysis takes precedence if there is a discrepancy; the registry record identifies no discrepancy.
The response percentages are estimates based on relatively small groups, and their confidence intervals are wide. The unadjusted p-values do not account for the examination of multiple outcomes or other possible sources of analysis uncertainty. The registry lists five outcome measures and three secondary outcomes, but reports no analyses for them beyond the posted response summaries. The data should therefore be read as descriptive and exploratory rather than as definitive comparative evidence.
Overall, the record gives arm-specific median progression-free survival and response summaries, but it does not include a reported primary comparative analysis. The posted numbers describe what was observed in this trial; they do not establish that adding reovirus changed progression-free survival or tumor response.
9. Statistical Methods Explained
The posted results include an endpoint measured as time to an event and secondary outcomes expressed as percentages. These require different summaries and different interpretations. The registry supplies arm-level medians and confidence intervals for progression-free survival, and percentages with confidence intervals for tumor response. The methods behind the sponsor’s primary analysis are not reported in the registry record.
What does a median summarize?
For a time-to-event outcome, the median is a point on the event-time distribution rather than an average of all observed times. Participants who have not experienced the event by their last recorded follow-up may contribute information up to that point, depending on the analysis method. This is why a median cannot be interpreted as though every participant had an observed event at that time. The endpoint definition includes progression, death, or date last seen, but the handling of censoring and the estimation method are not reported in the registry record.
A 95% confidence interval expresses uncertainty around an estimate under the assumptions of the method used to calculate it. It is not a range that contains the true value with a 95% probability after the data have been observed. In repeated use of a valid method under its assumptions, intervals constructed in this way would capture the underlying value at the stated rate. Precision depends on the amount and pattern of available information, among other factors. The registry posts intervals for each arm but does not state how they were calculated.
Why is a hazard ratio not interchangeable with medians?
A hazard ratio compares event rates over time under a time-to-event model. It can use more of the event-time information than a comparison of two medians, but its interpretation depends on model assumptions, including whether the relative event rate is reasonably stable over time for the model used. The registry record does not post a sponsor-reported hazard ratio or identify the model used for the primary analysis. The posted medians should not be treated as a substitute for that missing comparative estimate. Nor should an unadjusted recalculation based only on medians be presented as if it were the trial’s sponsor analysis.
How should the response comparisons be read?
The response outcomes are binary: each participant is classified according to whether a response occurred under the relevant definition. A percentage estimates the proportion meeting that definition. Its confidence interval reflects uncertainty in that proportion. A risk difference expresses the difference between two proportions on the probability scale. When its confidence interval includes zero, the interval is compatible with no difference as well as with effects in either direction at the confidence level used. The posted recalculated risk-difference intervals for both response outcomes cross zero. The corresponding unadjusted p-values are 0.588 and 0.633.
These risk differences and p-values are simple unadjusted recalculations from the posted summary statistics. They are not reported analyses by the sponsor. The registry lists no reported analyses for these outcomes. The percentages in the arm summaries may also differ slightly from calculations based on the underlying participant counts because the posted percentages are rounded. Such rounding does not resolve the broader uncertainty represented by the intervals.
What do the planning illustrations mean?
The sample-size illustrations are based on the observed effect, not on the trial’s original design. They assume a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Separate rows consider detecting 100%, 75%, or 50% of the observed effect. For example, for the RECIST outcome, the illustration for 100% of the observed effect lists 1,444 participants per arm for 80% power and 1,932 participants per arm for 90% power. These are planning illustrations only. They do not indicate the power of the completed trial, and they are not the number of participants who were observed.
In general, smaller effects require larger samples to detect with a fixed power and significance level, all else being equal. Power is a design probability conditional on assumptions about the effect, variability, analysis, and sample size; it is not the probability that a result is true. Because the illustration uses an effect observed in this trial, it should not be mistaken for the sponsor’s original sample-size justification. That justification is not reported in the registry record. For time-to-event outcomes, a sample-size calculation may depend on the number of events rather than only the number of participants; no such planning calculation is posted for the primary endpoint.
Over-dispersion is a general issue for count outcomes when variability exceeds the level assumed by a simple model. It can make standard errors too small and confidence intervals too narrow if ignored. The posted primary endpoint is time-to-event, and the response outcomes are binary, so an over-dispersed count model is not identified as the method used for these results. The statistical model and any adjustments used in the sponsor’s analyses are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists five outcome measures and three secondary outcomes, but it does not report a multiplicity strategy. When several outcomes or comparisons are examined, the probability of at least one apparently unusual result can increase. Statistical approaches to address this include prespecifying a primary outcome, allocating the significance level across tests, or treating secondary analyses as exploratory. Which approach, if any, was used for this trial is not reported in the registry record.
The record lists no reported analyses. In particular, it does not provide a sponsor-reported hazard ratio, primary endpoint p-value, or formal comparison of progression-free survival. The unadjusted response p-values and risk differences are recalculations from posted summary statistics and should not be confused with the sponsor’s own analyses. The record identifies no discrepancy, but the sponsor’s own analysis takes precedence if a discrepancy arises.
Missing-data procedures are not reported in the registry record. This includes how unavailable endpoint assessments, incomplete follow-up, or missing response evaluations were handled. The primary endpoint definition includes the date last seen, but the record does not explain censoring rules or provide details about follow-up completeness. The number of participants included in each endpoint summary is posted, but the analysis-population definition is not. It is not reported whether the analyses followed an intention-to-treat, per-protocol, or other population.
The record also does not report the statistical analysis plan, interim analyses, sample-size justification, or the sponsor’s approach to model selection and adjustment. These omissions limit the ability to determine how closely the posted results correspond to prespecified analyses. They do not establish that such procedures were absent; they mean that the relevant details are not reported in the registry record.
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 |
|---|---|---|---|
| Arm I (Paclitaxel) | 17 | 48 | 35.4% |
| Arm II (Paclitaxel and Wild-type Reovirus) | 24 | 52 | 46.2% |
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 |
|---|---|
| Arm I (Paclitaxel) | 48 of 48 |
| Arm II (Paclitaxel and Wild-type Reovirus) | 52 of 52 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm I (Paclitaxel) | Arm II (Paclitaxel and Wild-type Reovirus) |
|---|---|---|---|
| Small Intestinal Obstruction | Gastrointestinal disorders | 6 of 48 | 4 of 52 |
| Neoplasms Benign, Malignant And Unspecified (Incl | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 48 | 5 of 52 |
| Ascites | Gastrointestinal disorders | 1 of 48 | 2 of 52 |
| Lung Infection | Infections and infestations | 1 of 48 | 2 of 52 |
| Neutrophil Count Decreased | Investigations | 0 of 48 | 3 of 52 |
| Anemia | Blood and lymphatic system disorders | 0 of 48 | 2 of 52 |
| Intra-Abdominal Hemorrhage | Gastrointestinal disorders | 0 of 48 | 2 of 52 |
| Acute Kidney Injury | Renal and urinary disorders | 1 of 48 | 1 of 52 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 48 | 1 of 52 |
| Colonic Perforation | Gastrointestinal disorders | 1 of 48 | 0 of 52 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm I (Paclitaxel) | Arm II (Paclitaxel and Wild-type Reovirus) |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 43 of 48 | 48 of 52 |
| Fatigue | General disorders | 40 of 48 | 44 of 52 |
| Nausea | Gastrointestinal disorders | 35 of 48 | 44 of 52 |
| White Blood Cell Decreased | Investigations | 35 of 48 | 42 of 52 |
| Alopecia | Skin and subcutaneous tissue disorders | 35 of 48 | 36 of 52 |
| Constipation | Gastrointestinal disorders | 28 of 48 | 37 of 52 |
| Neutrophil Count Decreased | Investigations | 25 of 48 | 39 of 52 |
| Peripheral Sensory Neuropathy | Nervous system disorders | 30 of 48 | 33 of 52 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 24 of 48 | 30 of 52 |
| Anorexia | Metabolism and nutrition disorders | 22 of 48 | 27 of 52 |
Serious events with the highest arm-level rate: small intestinal obstruction (12.5%), neoplasms benign, malignant and unspecified (incl (9.6%), neutrophil count decreased (5.8%), anemia (3.8%), intra-abdominal hemorrhage (3.8%).
The serious adverse-event summaries use denominators of 48 participants in the paclitaxel arm and 52 in the combination arm, rather than the 54 participants listed in each arm for the primary endpoint and response results. Serious adverse events were reported for 17 of 48 participants receiving paclitaxel and 24 of 52 receiving paclitaxel plus reovirus. Other adverse events were reported for 48 of 48 and 52 of 52 participants, respectively. The reason the safety denominators differ from the endpoint group sizes is not reported in the registry record.
The listed serious adverse-event terms include small intestinal obstruction at 12.5%, neoplasms benign, malignant and unspecified at 9.6%, decreased neutrophil count at 5.8%, anemia at 3.8%, intra-abdominal hemorrhage at 3.8%, and ascites at 3.8%. These are term-level summaries; they do not by themselves describe severity, timing, duration, relatedness to treatment, or whether an individual experienced more than one event. Death counts are not reported in the registry record.
These figures are descriptive. Differences in counts or percentages between groups do not establish a causal safety difference, particularly without details about event definitions, exposure, follow-up, or attribution. They should be read alongside the registry’s definitions and denominators, not as a complete assessment of comparative safety.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized phase II comparison of weekly paclitaxel alone with weekly paclitaxel plus wild-type reovirus for recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer. The posted primary endpoint summaries give median progression-free survival and 95% confidence intervals for each arm. They do not include a sponsor-reported hazard ratio or formal comparative analysis. The medians and intervals describe the observed results but do not establish whether the regimens differ.
The two secondary response summaries also have substantial uncertainty. Their unadjusted recalculated risk-difference intervals cross zero, and the response measures point in different directions at the arm-summary level. These results do not provide clear, consistent evidence of a difference. They are exploratory in the absence of a reported multiplicity plan and sponsor-reported analyses.
The findings should not be interpreted as proving equivalence or proving that the treatments have no difference. A non-significant p-value, or an interval that includes zero, is not proof that two groups are identical. It indicates that the available evidence does not distinguish a difference from no difference at the specified level of precision and under the analysis assumptions. The registry does not report enough comparative detail for a definitive statistical conclusion about the primary endpoint.
Nor do the summaries establish that adding reovirus improves or worsens outcomes. They are results from this trial, with its enrolled population, treatment schedules, follow-up, and analysis reporting. The record does not give the sponsor’s full analysis plan, missing-data procedures, or analysis populations, and it does not post the overall-survival result listed among the secondary outcomes. These limits matter when assessing what can be inferred.
The appropriate reading is therefore bounded: the registry reports arm-specific outcome and safety summaries, while important details needed for a full comparative interpretation are not reported in the registry record. The numerical results are informative descriptions of the trial, but they should not be turned into medical advice or a claim that one regimen works or does not work.
13. Why This Trial Matters Statistically
This trial illustrates why an arm-level median is not the same as a treatment comparison. Progression-free survival is a time-to-event outcome, and the registry posts a median with a confidence interval for each arm. Without a sponsor-reported hazard ratio, formal comparison, or details of the analysis method, readers cannot tell from those summaries alone how the full event-time data were compared.
It also demonstrates the importance of reading uncertainty alongside point estimates. The response percentages and their confidence intervals do not provide a precise, consistent separation between groups. The unadjusted recalculations are useful for orientation, but they are not substitutes for prespecified analyses and do not address the consequences of examining multiple outcomes.
The safety summaries show another practical issue: denominators can differ across outcome types. The registry reports endpoint group sizes of 54 per arm but safety denominators of 48 and 52. Without an explanation of these differences, readers should not assume that every endpoint uses the same analysis population. Clear reporting of denominators, missing-data handling, and outcome definitions is essential to understand how results relate to enrolled participants.
Finally, the sample-size illustrations are based on observed effects rather than the trial’s own design assumptions. They can help explain the scale of a future planning exercise, but they are not observed power and do not reveal the original sample-size rationale. This distinction is important whenever retrospective calculations are placed beside trial results. The registry record makes the outcome summaries available, while leaving several key analytic details unreported.
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 main limitation for statistical interpretation is the absence of a sponsor-reported comparative analysis for progression-free survival. The record posts medians and confidence intervals but does not report a hazard ratio, a primary endpoint p-value, or the statistical method used to estimate and compare the groups. The time-to-event summaries therefore do not provide a complete account of the primary comparison.
Details about censoring, follow-up completeness, missing endpoint assessments, and analysis populations are not reported in the registry record. Although the primary endpoint is defined as time to progression, death, or date last seen, the record does not explain how participants without an observed event were handled in the analysis. The reasons for the difference between endpoint and safety denominators are also not reported.
The secondary response comparisons are unadjusted recalculations from summary statistics, not sponsor-reported analyses. No multiplicity procedure is reported, and the registry lists no reported analyses for the secondary outcomes. The overall-survival outcome is listed, but its result is not included in the posted secondary results. These gaps limit assessment of the breadth and consistency of the evidence.
The registry does not report the randomization procedure, allocation concealment, detailed statistical analysis plan, interim analyses, or original sample-size justification. Open-label treatment is reported, but the record does not state how outcome assessment or other potential sources of bias were addressed. These are reporting limitations; they do not show that any particular safeguard was or was not used.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer — NCT01199263.
- Registry record last updated 2020-09-16; status last verified 2020-08.
- Results first posted 2019-10-30.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01199263 is a completed randomized phase II trial sponsored by the National Cancer Institute. It compared weekly paclitaxel with weekly paclitaxel plus wild-type reovirus in patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer. The registry lists 108 participants and 54 participants per arm in the primary and response summaries.
The primary endpoint was progression-free survival, reported as an arm-specific median with a 95% confidence interval. Secondary results include tumor response by RECIST and CA125. The registry does not report a sponsor-derived comparative analysis for the primary endpoint, a multiplicity plan, or key details about missing data and analysis populations. Safety summaries use different denominators from the endpoint results.