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 Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate (NCT00165503), a na phase 2 study. The primary outcome is Adjuvant Chemotherapy Completion Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00165503 |
| Phase | Phase 2 |
| Condition | Pleural Mesothelioma, Malignant Pleural Mesothelioma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Dana-Farber Cancer Institute |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled participants with pleural mesothelioma, also described in the registry as malignant pleural mesothelioma. The registry lists 16 enrolled participants. The intended population for the feasibility question was patients undergoing surgery with heated cisplatin; further eligibility details are not reported in the registry record.
Intervention
The treatment approach combined pleurectomy/decortication with heated cisplatin administered during surgery, followed by intravenous sodium thiosulfate. Adjuvant cisplatin and ALIMTA were planned to begin 6-10 weeks after surgery. The registry describes the heated cisplatin as a lavage of the chest and abdominal cavity.
Comparator
There was no comparator group. The study is listed as a single-group phase II study, with allocation recorded as not applicable and masking as none. Its results therefore cannot provide a randomized or concurrent comparison between this approach and another treatment strategy.
Primary question
The primary endpoint asked whether participants could complete 3 cycles of adjuvant cisplatin and ALIMTA after surgery with hyperthermic cisplatin. The registry defines feasibility through this chemotherapy completion rate. It also describes aims to assess effects of the combined approach, study cisplatin distribution and excretion, and collect discarded tumor samples for genetic analysis. None of the enrolled participants were evaluated for the primary endpoint because none received the experimental adjuvant chemotherapy per protocol. The completion rate is therefore not estimable from the posted primary-endpoint data.
3. Trial Design
This was a phase II study with a single-group model. The registry lists 16 enrolled participants and no comparator arm. Allocation is recorded as not applicable, and masking as none. The intervention combined pleurectomy/decortication with heated cisplatin during surgery and sodium thiosulfate, with adjuvant cisplatin and ALIMTA planned afterward. The registry identifies the study status as terminated. The reason for termination is not reported in the registry record.
The main feasibility objective concerned completion of adjuvant chemotherapy. The regimen was expected to start 6-10 weeks after surgery, and completion was defined as receiving 3 cycles of cisplatin and ALIMTA. The registry notes that, given the 21-day cycle, those 3 cycles approximate 9 weeks in addition to the period from registration and postoperative recovery, which could be up to 10 weeks. These timings describe the endpoint context; they do not establish that participants actually began or completed the regimen.
The registry states that none of the enrolled participants were evaluated for this endpoint because none received the experimental adjuvant chemotherapy per protocol. Consequently, the central feasibility outcome has no evaluable participant data in the record. The reasons participants did not receive that chemotherapy, and whether the planned regimen was modified or omitted for particular reasons, are not reported in the registry record.
The study also aimed to characterize effects of the combined treatment approach, examine where cisplatin goes and how it is excreted, and analyze discarded tumor samples for genetic information. The outcome and analysis record lists one outcome measure and no analyses. Detailed results for the other aims are not reported in the registry record. A control comparison, randomization procedure, or masked assessment is not part of the recorded design. This design can describe what occurred within the treated group, but it cannot isolate the contribution of any one treatment component from the others or compare outcomes causally with an alternative approach.
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 | Cisplatin, Sodium Thiosulfate, Alimta |
|---|---|
| STARTED | 16 |
| COMPLETED | 0 |
| NOT COMPLETED | 16 |
Reasons for not completing this period:
| Reason | Cisplatin, Sodium Thiosulfate, Alimta |
|---|---|
| Death | 1 |
| Lost to Follow-up | 12 |
| Unresectable | 3 |
Analysis population for the primary outcome, as defined in the registry: None of the enrolled participants were evaluated for the primary endpoint since none received the experimental adjuvant chemotherapy per protocol.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Cisplatin, Sodium Thiosulfate, Alimta |
|---|---|---|
| Participants analysed | 16 | |
| Age, Continuous | years | 71.5 (45 to 84) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 12 |
| Race/Ethnicity, Customized: Hispanic | participants | 0 |
| Race/Ethnicity, Customized: Non-Hispanic | participants | 16 |
| Region of Enrollment: United States | participants | 15 |
| Region of Enrollment: Israel | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Adjuvant Chemotherapy Completion Rate, measured over Given the 21-day cycle, 3 cycles of adjuvant chemotherapy approximates 9 weeks in addition to the time from registration and post-surgery which was up to 10 weeks..
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the adjuvant chemotherapy completion rate. It was defined as the percentage of patients completing 3 cycles of cisplatin and ALIMTA beginning 6-10 weeks after surgery with hyperthermic cisplatin. The endpoint was intended to operationalize feasibility: rather than treating feasibility as a broad impression, it focused on whether the planned postoperative chemotherapy could be delivered through the specified course.
The registry connects this measure to treatment timing. With a 21-day cycle, 3 cycles approximate 9 weeks, in addition to the period from registration and postoperative recovery, described as up to 10 weeks. That context makes the endpoint dependent on more than a decision to prescribe chemotherapy: participants would need to reach the postoperative treatment period and receive the regimen as specified. The record does not provide additional rules for how partial completion, delays, dose changes, or discontinuation were handled.
No primary-endpoint completion rate can be calculated from the posted results. The registry explicitly says that none of the enrolled participants were evaluated for the endpoint because none received the experimental adjuvant chemotherapy per protocol. This is not the same as a recorded completion rate of zero: there are no evaluable participants on which to estimate the defined rate. Why the regimen was not received per protocol is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The key interpretive fact is that the primary endpoint has no evaluable participants. Although 16 participants were enrolled, the registry states that none were evaluated for the adjuvant chemotherapy completion endpoint because none received the experimental adjuvant chemotherapy per protocol. Enrollment alone is not a denominator for a completion rate when the endpoint population is explicitly nonevaluable. The completion rate should therefore be treated as unavailable, not as zero and not as evidence that any particular proportion could or could not complete treatment.
This distinction matters for a feasibility study. A completion rate would summarize delivery of the planned postoperative regimen among the endpoint-defined population. With no evaluable endpoint data, the registry cannot quantify that aspect of feasibility. Nor can it establish why the regimen was not received per protocol: the reasons are not reported in the registry record. The termination status is recorded, but the reason for termination is also not reported in the registry record.
The study was single-group, with no comparator. Even if an outcome estimate were available, a single-group description would not determine how the same participants would have fared under another strategy. It also would not separate the effects of surgery, heated cisplatin, sodium thiosulfate, and postoperative chemotherapy. Here the main endpoint itself is unavailable, so the record does not support a comparative interpretation or an estimate of the planned regimen's completion rate.
The safety record is a separate source of descriptive information. The serious adverse event group lists 16 participants at risk and 5 affected. It lists 0 affected for other adverse events among 16 at risk. These counts should be read as registry-recorded group summaries, not as a comparison against another treatment group. Serious adverse event terms include respiratory failure, pericardial effusion with tamponade, progression of disease, hypocalcemia, chylothorax, and aspiration pneumonia; their listed percentages are descriptive registry entries. The record does not provide a control group or a causal attribution analysis that would identify how much of any event was due to a particular component of the treatment approach.
No analysis results are listed for the outcomes, and no numerical estimate or confidence interval for the primary completion rate is reported. A confidence interval would ordinarily communicate the precision of an estimated rate, but with no endpoint observations there is no rate estimate for such an interval to describe. The record also does not report a statistical analysis plan, interim analyses, or a sample-size justification. Accordingly, the registry supports a careful account of enrollment, the planned endpoint, its nonevaluable status, and the recorded adverse-event summaries, but not a quantitative conclusion about primary-endpoint feasibility.
9. Statistical Methods Explained
The methods that can be interpreted from the registry begin with the design: this was a single-group phase II study with 16 enrolled participants and no comparator. The primary endpoint was a completion rate for postoperative chemotherapy. However, no participant was evaluated for this endpoint because none received the experimental adjuvant chemotherapy per protocol. The registry does not report an endpoint estimate or an analysis result. The statistical interpretation must therefore center on the absence of evaluable endpoint data rather than on an estimated treatment effect.
What does a completion rate represent?
General statistical context: a completion rate is a proportion. It requires a clearly defined denominator of participants eligible for assessment and a rule for which participants count as completing the specified regimen. A rate can then describe the observed proportion meeting that rule. In this study, the endpoint definition was completion of 3 cycles of cisplatin and ALIMTA beginning 6-10 weeks after surgery. The registry says no participants were evaluated for this endpoint. It does not give an alternative denominator or an observed rate, so the endpoint cannot be reconstructed from enrollment alone.
General statistical context: the denominator is part of the endpoint, not a detail that can be chosen after the results are known. For example, enrolled participants, treated participants, and participants who reach a postoperative treatment stage can represent different analysis populations. The registry specifically identifies the primary endpoint population as having no evaluated participants. It does not explain whether any other population definition was considered or how deviations from the intended postoperative regimen would have been handled.
Why is a confidence interval unavailable?
General statistical context: a confidence interval expresses the uncertainty around an estimate, such as a proportion. Its width depends on the amount of information in the observed data and the underlying statistical method. It is not a substitute for missing observations. Since the record gives no evaluated participants and no completion-rate estimate, it gives no basis for a confidence interval around that rate. This is different from having a wide interval that still reflects observed outcomes: no primary-endpoint estimate is reported at all.
The registry does not report a p-value for this endpoint or an inferential test. A p-value, when used, addresses compatibility between data and a specified statistical hypothesis under a model; it does not measure the size or clinical importance of an effect. Here, without an endpoint estimate and without a reported comparison or analysis, there is no p-value to interpret. No hypothesis-testing procedure for the primary endpoint is reported in the registry record.
What can a single-group design establish?
General statistical context: a single-group study can describe outcomes observed among participants who receive a study approach. It does not directly show what would have occurred in a concurrent alternative group. The absence of random allocation means that comparisons with outside populations or historical experience, if made, would require assumptions and could be affected by differences in patients, care, or outcome ascertainment. The registry does not report such a comparison. In this record, the absence of a comparator and of primary-endpoint observations means neither a within-trial contrast nor a comparative treatment effect is available.
The intervention itself was a combined approach: surgery, intraoperative heated cisplatin, sodium thiosulfate, and planned adjuvant cisplatin and ALIMTA. General statistical context: when several components are delivered together, a single-group outcome cannot ordinarily disentangle the contribution of each component without additional design features or analyses. No component-specific causal analysis is reported in the registry record. The intended endpoint focused on completion of adjuvant chemotherapy, not an estimate isolating the effect of any individual treatment component.
How should planning calculations be read?
General statistical context: sample-size calculations are planning illustrations under stated assumptions. They describe the number of participants a hypothetical design might require for a specified effect, significance level, allocation, and statistical model. They are not observed power, and they do not establish that a study had adequate information for its actual results. The registry's stated planning assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of an observed effect. The record also notes that time-to-event calculations use a total event count, while other calculations use participants per arm.
Those assumptions do not match the recorded single-group design with no comparator, and the primary outcome has no evaluable observations. The reason for that apparent difference between the planning assumptions and the recorded design is not reported in the registry record. The registry does not report the trial's own sample-size justification. No planning figure can replace the missing primary-endpoint data or be read as evidence of the study's observed power. The effect estimate used for the planning illustration and its relationship to the outcomes in this record are not reported in the registry record.
Why does over-dispersion matter in general?
General statistical context: over-dispersion occurs when observed variability is greater than a statistical model assumes. If the model understates variability, standard errors and confidence intervals may be too small, and tests may appear more decisive than the data warrant. This concept is relevant when choosing models for count or rate outcomes, but the registry does not report an analysis model for this study or evidence that over-dispersion was assessed. It would therefore be inappropriate to claim that over-dispersion was present or corrected for in the study.
More broadly, analysis details such as the statistical model, handling of protocol deviations, missing-data method, and confidence-interval method are not reported in the registry record. The available interpretation is consequently descriptive: enrollment, the endpoint definition, the explicit nonevaluable status, and the recorded adverse-event summaries. No unreported statistical procedure should be assumed to have been performed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure and no analyses. It does not report a statistical analysis plan, a hierarchy of hypotheses, or procedures for controlling multiplicity. Multiplicity arises when several outcomes or statistical tests are considered: the more opportunities there are to identify a result as notable, the more important it is to define in advance which tests are primary and how interpretation will account for multiple testing. This is general statistical context, not a description of a method documented for this study.
The registry's summary also describes several study aims: feasibility of adjuvant chemotherapy, effects of the combined approach, cisplatin distribution and excretion, and genetic analysis of discarded tumor samples. The presence of several aims does not by itself reveal how many tests were performed or whether any adjustment was planned. Such details are not reported in the registry record. No analysis results are listed, so there are no reported outcome tests from which to assess multiplicity adjustment.
For missing primary-endpoint data, the record states that no enrolled participants were evaluated because none received the experimental adjuvant chemotherapy per protocol. This is more specific than an unspecified amount of missing outcome data: the endpoint has no evaluable participants. The record does not explain the reasons for nonreceipt, report an imputation method, or describe sensitivity analyses. It also does not state whether any post hoc analysis population was used.
Analysis populations such as intention-to-treat, per-protocol, or treated populations are not specified in the registry record for the primary endpoint. The registry does not report how eligibility, discontinuation, protocol deviations, or incomplete cycles would have been handled. In the absence of these details, the endpoint should not be recast as a rate using all enrolled participants as the denominator. The reported status is that no participants were evaluated for the endpoint, and the completion rate is not available.
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 |
|---|---|---|---|
| Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate | 5 | 16 | 31.2% |
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 |
|---|---|
| Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate | 0 of 16 |
Most frequent serious adverse event terms
| Event term | Organ system | Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate |
|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 3 of 16 |
| Pericardial effusion with tamponade | Respiratory, thoracic and mediastinal disorders | 1 of 16 |
| Progression of disease | Respiratory, thoracic and mediastinal disorders | 1 of 16 |
| Hypocalcemia | Blood and lymphatic system disorders | 1 of 16 |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | 1 of 16 |
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | 1 of 16 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 1 of 16 |
| Elevated troponin | Blood and lymphatic system disorders | 1 of 16 |
Serious events with the highest arm-level rate: respiratory failure (18.8%), pericardial effusion with tamponade (6.2%), progression of disease (6.2%), hypocalcemia (6.2%), chylothorax (6.2%).
The registry lists one adverse-event group: surgery with heated cisplatin lavage and sodium thiosulfate. It records 16 participants at risk for serious adverse events and 5 affected. For other adverse events, it records 16 at risk and 0 affected. These figures are group-level registry summaries; they do not compare the intervention with a control group. The registry does not report deaths for this group.
The listed serious adverse event terms and percentages are respiratory failure, 18.8%; pericardial effusion with tamponade, 6.2%; progression of disease, 6.2%; hypocalcemia, 6.2%; chylothorax, 6.2%; and aspiration pneumonia, 6.2%. These are the registry's reported entries and should not be treated as evidence that any particular treatment component caused an event. The record does not provide event-level timing, severity grades beyond the serious-event classification, attribution, or a comparative safety analysis.
General statistical context: adverse-event summaries depend on how events and affected participants are defined, the period of observation, and the completeness of reporting. The registry record does not provide all those details. The listed counts and percentages are descriptive and cannot establish comparative risk or rule out events that were not captured or reported.
12. What the Result Does, and Does Not, Mean
The record establishes that this phase II study enrolled 16 participants and was designed around a combined surgical and drug approach for pleural mesothelioma. Its primary feasibility measure was completion of 3 cycles of adjuvant cisplatin and ALIMTA, starting 6-10 weeks after surgery. The registry states that none of the enrolled participants were evaluated for this endpoint because none received the experimental adjuvant chemotherapy per protocol. Thus, the primary completion rate is not available in the posted results.
This result does not mean that the completion rate was zero. A zero rate would require an evaluable group in which no one completed the regimen. The registry instead reports no evaluated participants for the endpoint. The distinction is essential: no rate can be estimated from an endpoint population with no evaluable participants. The reason the postoperative chemotherapy was not received per protocol is not reported in the registry record.
The record also does not establish that the combined approach was feasible or infeasible overall, nor does it provide an estimate of treatment effect. The absence of a comparator means the study cannot offer a randomized comparison with another approach. The use of multiple treatment components also prevents attribution of a hypothetical outcome to one component without additional evidence. The listed adverse-event summaries describe reported events in the study group but do not demonstrate comparative safety or causation.
Nor can the registry support conclusions about the cisplatin distribution, excretion, or tumor genetic-analysis aims: detailed results for those aims are not reported in the registry record. No primary-outcome analysis or inferential estimate is listed. The study's terminated status is recorded, but the reason is not reported.
The defensible interpretation is narrow. The registry describes the study design, enrollment, intended chemotherapy-completion endpoint, its nonevaluable status, and adverse-event summaries. It does not provide the information needed to quantify the primary feasibility outcome, explain why the regimen was not received per protocol, or compare outcomes with another treatment strategy. These limits apply to interpretation of the registry record and should not be filled by assuming unreported protocol decisions or analyses.
13. Why This Trial Matters Statistically
This study illustrates a central statistical issue in feasibility research: a carefully defined outcome is useful only if participants can be evaluated for it. The registry made completion of 3 cycles of adjuvant chemotherapy the primary feasibility measure, with treatment intended to begin 6-10 weeks after surgery. Yet it states that no participants were evaluated because none received the experimental adjuvant chemotherapy per protocol. The intended measure therefore cannot yield a completion-rate estimate in this record.
That distinction is important because enrollment and endpoint assessment answer different questions. Enrollment describes recruitment into a study; it does not automatically indicate that participants reached or received the treatment needed to assess a postoperative feasibility endpoint. A denominator must correspond to the endpoint definition. Treating all 16 enrolled participants as if they had been evaluated would contradict the registry's explicit statement about the primary endpoint.
The single-group design also makes clear what can and cannot be inferred. It can record what happened within the study group, including the listed serious adverse events. It does not provide a concurrent counterfactual group, and therefore cannot isolate comparative effects or assign outcomes to particular components of a combined approach. This is an important distinction between descriptive reporting and causal comparison.
Finally, the study demonstrates why missing analysis details matter. The registry does not report a statistical analysis plan, an endpoint estimate, or an explanation for nonreceipt of the postoperative regimen. Without these, readers cannot assess planned handling of deviations, the intended analysis population, or the precision of an endpoint estimate. Transparent reporting of nonevaluable outcomes is itself informative, but it does not substitute for the missing outcome data. Statistical interpretation must remain aligned with what the record documents rather than treating planning assumptions or enrollment as evidence of an observed feasibility result.
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 most consequential limitation is the absence of evaluable data for the primary endpoint. The registry explicitly states that none of the 16 enrolled participants were evaluated because none received the experimental adjuvant chemotherapy per protocol. The completion rate is therefore unavailable, and the record does not explain why the planned regimen was not received. This prevents a quantitative assessment of the study's central feasibility question.
The study was single-group and had no comparator. Consequently, the record cannot provide a direct comparison with another strategy or isolate the effect of individual treatment components. Allocation is listed as not applicable, and masking as none. The registry does not report details of outcome assessment that would allow further evaluation of potential ascertainment limitations.
The study is listed as terminated, but the reason for termination is not reported in the registry record. The registry also does not report a sample-size justification, detailed statistical analysis plan, interim analyses, missing-data procedure, or analysis population for the primary endpoint. It lists no outcome analyses. These omissions limit assessment of the planned inferential approach as well as interpretation of any intended comparisons.
The adverse-event information is descriptive. The record gives group-level counts and selected serious-event terms but does not report event-level timing, attribution, or a comparative analysis. Deaths are not reported in the registry record. Detailed results for the stated cisplatin pharmacologic and tumor-sample aims are also not reported in the registry record. These constraints mean that the available record supports a limited description of enrollment, endpoint status, and recorded safety summaries, rather than a comprehensive assessment of efficacy, feasibility, or safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate — NCT00165503.
- Registry record last updated 2016-09-09; status last verified 2016-07.
- Results first posted 2016-09-09.
- 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
The registry describes a phase II, single-group study of pleurectomy/decortication with intraoperative heated cisplatin and sodium thiosulfate, followed by planned adjuvant cisplatin and ALIMTA, in pleural mesothelioma. It lists 16 enrolled participants and a terminated study status. The primary endpoint was completion of 3 cycles of adjuvant chemotherapy beginning 6-10 weeks after surgery.
No participants were evaluated for the primary endpoint because none received the experimental adjuvant chemotherapy per protocol. The completion rate is therefore unavailable, not a reported zero. The registry lists serious adverse events in the study group, but there is no comparator. It does not report the reason for termination, the reason for nonreceipt of the regimen, a sample-size justification, or a detailed analysis plan.