Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer (NCT00085631), a randomized phase 3 study. The primary outcome is Primary Tumor Response Rate at 4-6 Weeks Post Treatment.

2. Clinical Question

The trial is described as a randomized phase III study for locally advanced cervical cancer. Its stated purpose was to compare safety and efficacy between chemoradiotherapy with hyperthermia and chemoradiotherapy alone. The primary outcome is framed as tumor response, rather than a time-to-event outcome. That makes the central statistical question a comparison of response proportions between the randomized groups.

The registry record does not provide the observed response proportion in either arm, an effect estimate for the difference between groups, or a confidence interval. It therefore does not establish how the recorded endpoint differed between the treatment strategies. The study status is terminated, but the reason for termination is not reported in the registry record.

3. Trial Design

This is a randomized, parallel-group phase III trial. The registry lists masking as none, so the design is recorded as unmasked. Enrollment is recorded as 101. That is the registry’s enrollment figure; the record does not state how many participants were randomized to each arm, received treatment, or contributed data to the primary outcome.

The intervention arm combined cisplatin and radiation therapy with hyperthermia treatment. Its description says cisplatin was administered intravenously, hyperthermia was given over 60-90 minutes on day 1, and external beam radiation therapy was given once daily on days 1-5. This treatment was to repeat weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity. The comparator arm is described as receiving cisplatin and external beam radiation therapy, including brachytherapy, without hyperthermia. The description of the intervention arm ends mid-sentence in the registry record, so the full treatment description is not available there.

The registry gives a start date of 2003-03 and a primary completion date of 2008-11. It lists the trial status as terminated. The reason for that status, details of the randomization process, allocation concealment, and any changes to the design are not reported in the registry record.

Random allocation is intended to make treatment groups comparable on average, including on factors that may affect outcomes but were not measured. That is a general property of randomized designs, not evidence that balance was achieved in this particular trial. Without group sizes, baseline characteristics, treatment exposure, and outcome data, the registry record does not allow readers to assess those features or the extent to which the intended comparison was carried out.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Participant flow includes patients who were enrolled and randomized into the study. A third group of patients (Unavailable) was added in this participant flow to account for patients who were randomized, but whose treatment assignment was not documented in the current data.

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.

6. Primary Endpoint

The registry lists the primary outcome as Primary Tumor Response Rate at 4-6 Weeks Post Treatment, measured over 3 months from start of therapy.

The primary endpoint is titled “Primary Tumor Response Rate at 4-6 Weeks Post Treatment.” Its description defines response as the proportion of subjects whose best response was complete response (CR) or partial response (PR), according to RECIST criteria for change in the sum of longest diameters. The endpoint therefore classifies tumor response and expresses the outcome as a proportion of participants in the relevant analysis population.

Response endpoints are used to describe whether tumors meet prespecified criteria for shrinkage or disappearance during assessment. In general, a proportion can be compared across randomized groups to estimate whether response frequency differs between treatment strategies. That comparison needs the number meeting the response definition and the denominator evaluated in each group, along with an estimate of uncertainty. Those values are not reported in the registry record.

The timing is described in two ways: the endpoint title specifies 4-6 weeks after treatment, while the timeframe field says 3 months from start of therapy. These descriptions use different reference points, and the registry record does not explain how they relate or which timing governed the reported assessment.

The endpoint definition identifies the response categories and criteria, but does not report how missing or unevaluable assessments were handled, whether response was reviewed centrally, or which analysis population was intended. Those details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization contribute?

Randomization assigns participants to treatment strategies through a chance-based process. In general, this helps limit systematic differences between groups at the point of assignment and supports a fair comparison of outcomes. It does not guarantee that every measured or unmeasured characteristic will be balanced, particularly in a study with limited enrollment. The registry identifies the trial as randomized, but does not report the sequence-generation method, how assignments were concealed, or the allocation counts by arm. The practical details needed to assess how randomization was implemented are therefore not reported in the registry record.

The parallel design means participants are assigned to a treatment group and the groups are compared. The registry describes the study as unmasked. In general, lack of masking can affect care, assessment, and reporting, depending on the outcome and the safeguards used. The primary endpoint is based on tumor response under RECIST criteria, but the record does not say whether response assessment was blinded or independently reviewed. Those details are not reported in the registry record, so the possible influence of knowledge of treatment assignment cannot be assessed from this information.

How should a response proportion be interpreted?

For a categorical outcome such as complete or partial response, the basic descriptive measure is the proportion of participants meeting the response definition among those included in the relevant analysis. A comparative analysis then contrasts the proportions between treatment groups. Different statistical measures can express that contrast, and their interpretation depends on the chosen measure and analysis plan. No arm-specific response data or comparative statistic is reported for this trial.

A confidence interval is a statistical expression of uncertainty around an estimated effect. In general, a narrower interval indicates greater precision under the assumptions of the method, while a wider interval indicates less precision. It does not describe the range of outcomes for individual patients, and it does not repair limitations in data collection or analysis. Because the registry record has no primary response estimate or interval, the precision of the treatment comparison is unknown.

What does the endpoint definition establish?

The endpoint description establishes that complete and partial responses, as defined using RECIST criteria for change in the sum of longest diameters, count toward the response outcome. It also identifies a stated assessment period. Clear endpoint definitions are important because they specify what is counted as an event and help make results interpretable. Here, the record gives the title timing as 4-6 weeks post treatment and the timeframe as 3 months from start of therapy. The record does not explain the relationship between these timing descriptions.

Endpoint definitions do not by themselves specify the analysis population, how missing scans were treated, how best response was selected, or what statistical test or model was used. These details matter because different choices can affect both the denominator and the estimate. The registry record does not report these analysis details.

What can be inferred from the recorded enrollment?

Enrollment of 101 is a trial-level figure in the registry record. It should not be treated as the denominator for the primary response endpoint: the record does not give arm-specific denominators or say how many participants had an evaluable assessment. Nor can the enrollment figure alone establish the study’s power or precision. Those depend on factors including the allocation, outcome frequency, analysis method, and missing data.

Sample-size planning outputs are illustrations of what a hypothetical design might require under stated assumptions. They are not observed power and do not describe the achieved precision of this trial. The record does not report an original sample-size justification or the assumptions used in the trial’s own design. Any planning illustration based on an observed effect would also rely on a reported effect; the primary outcome estimates needed for such a comparison are not present in the registry record.

What analyses are documented?

The record lists 0 analyses. This means that no statistical analysis details or results are recorded in that part of the registry entry. It does not establish what analyses investigators conducted outside the registry or whether analyses were planned in a protocol. The statistical plan, including the method for comparing response proportions, any covariate adjustment, handling of interim analyses, and rules for stopping, is not reported in the registry record.

In general, a complete statistical report would connect the endpoint definition to the analysis population, explain how missing outcomes were handled, give results for each randomized group, and report a comparative estimate with its uncertainty. It would also clarify whether the analysis followed randomized assignment and whether any prespecified adjustments or sensitivity analyses were used. Without these elements, readers cannot reproduce or evaluate the primary comparison from the registry entry. No recalculated estimate is possible from the reported summary information.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 4 outcome measures, but records 0 analyses. It does not identify a statistical hierarchy among the outcomes, state how the primary outcome was prioritized in analysis, or describe whether adjustments for multiple comparisons were planned. Multiplicity arises when several outcomes or comparisons are tested; without a stated plan, readers cannot determine how the chance of a false-positive finding was managed. Since no outcome analyses are reported, the registry record does not permit an assessment of multiplicity in the results.

Missing-data handling is also not reported. The record does not say how participants without an evaluable tumor assessment were treated, whether missing outcomes were excluded or otherwise handled, or whether sensitivity analyses were planned. These choices can affect the denominator and the interpretation of a response proportion. Enrollment alone does not reveal the amount or pattern of missing endpoint data.

The analysis populations are not described. The registry does not report whether the primary analysis was based on randomized assignment, participants who received treatment, participants with an evaluable response assessment, or another defined group. It also does not give arm-specific participant counts for any analysis population. These details are not reported in the registry record.

The record does not provide the statistical analysis plan, interim-analysis procedures, or a sample-size justification for the trial. Their presence or absence in other trial documents cannot be inferred from the registry entry. Without results, analysis populations, and missing-data methods, the primary treatment comparison cannot be reconstructed or assessed for robustness.

11. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: thromboembolic event (3.0%), diarrhea (2.0%), myocardial infarction (1.0%), nausea (1.0%), vomiting (1.0%).

The adverse-event record gives an overall study group with 101 at risk. It lists 10 participants affected by serious adverse events and 54 affected by other adverse events. These are separate registry fields, and the record does not explain whether the groups overlap; the counts should not be added or treated as mutually exclusive.

The listed serious adverse event terms are thromboembolic event at 3.0%, diarrhea at 2.0%, myocardial infarction at 1.0%, nausea at 1.0%, vomiting at 1.0%, and allergic reaction at 1.0%. These percentages are the registry’s reported values. The record does not provide arm-specific figures for these terms, so they cannot be used to compare the treatment groups. Deaths are not reported in the registry record.

In general, adverse events recorded during a trial are not automatically evidence that treatment caused them. The overall summary does not establish causality, timing, severity beyond the serious-event classification, or the number of events per affected participant. Because the data are not separated by randomized arm, they describe aggregate safety reporting rather than a comparative safety estimate.

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

The registry record documents a randomized phase III trial that was designed to compare cisplatin and radiation therapy with versus without hyperthermia for locally advanced cervical cancer. It defines a primary tumor response endpoint using complete or partial response under RECIST criteria. It also records overall adverse-event information and a terminated status.

What the record does not provide is the primary response result. There are no response proportions by group, no treatment effect estimate, and no uncertainty interval. As a result, the posted results do not show whether the response outcome was higher, lower, or similar between the groups. Lack of a reported estimate is not evidence that the groups had the same outcomes.

The aggregate safety summary also does not show how adverse events differed between treatment groups. The overall counts and listed serious-event percentages cannot determine whether one strategy had more or fewer events, and they do not establish that events were caused by treatment. The registry does not report deaths in the adverse-event record, which should not be read as confirmation that no deaths occurred.

The terminated status gives context but not an explanation. The record does not identify why the trial was terminated, whether enrollment or follow-up was affected, or whether the planned statistical analysis was completed. It would be speculative to link termination to the treatment comparison or to any particular outcome.

These limitations mean the registry entry is informative about the trial question, design, endpoint definition, and some aggregate safety reporting, but not about the observed primary treatment contrast. A conclusion about the relative response results would require outcome data and analysis details that are not reported in the registry record. This interpretation concerns the completeness of the posted statistical evidence and does not give medical advice or a treatment recommendation.

13. Why This Trial Matters Statistically

This trial illustrates why a registry entry’s design information and outcome results answer different questions. Randomization and the stated endpoint describe how a comparison was intended to be made. They do not reveal the observed result. To interpret a randomized comparison, readers need the outcome data for each group, a clearly defined analysis population, and an estimate of the contrast with its uncertainty. Those elements are not reported for the primary response endpoint.

The case also shows why endpoint timing needs to be unambiguous. The endpoint title refers to 4-6 weeks after treatment, while the timeframe is recorded as 3 months from start of therapy. These different reference points can influence which assessment is treated as primary. The registry does not explain how they were reconciled, so the intended timing is not fully clear from the entry.

Aggregate safety counts provide another statistical lesson. Overall event figures can describe the record’s safety summary, but they cannot estimate a difference between randomized groups when they are not reported separately by arm. Counts for different event categories also should not be assumed to represent distinct participants or be combined without information on overlap.

Finally, a terminated status should prompt attention to reporting completeness, not an assumption about the reason or the outcome. In this record, the status appears alongside no recorded analyses and no primary response estimates. This makes the boundary between what is documented and what remains unknown especially important. Statistical interpretation depends on that distinction: a missing estimate cannot be replaced with a presumed null effect or a conclusion based on the study’s design alone.

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 primary limitation for interpreting this trial is that the registry record does not report the primary tumor response results or a comparison between arms. Without group-specific response counts, denominators, or an effect estimate, neither the direction nor the precision of the primary comparison can be assessed.

The recorded enrollment of 101 is not accompanied by arm-specific allocations, treatment exposure, or analysis-population counts. The record also does not describe missing or unevaluable response assessments, so the endpoint denominators and possible impact of missing data are unknown. The title and timeframe give different reference points for outcome timing, without an explanation of how they fit together.

The statistical analysis plan is not reported in the registry record. The entry does not describe the comparison method, any adjustment, the handling of multiple outcomes, or interim analyses. The reason for termination is also not reported, so its effect on enrollment, follow-up, or analysis cannot be assessed. The record identifies no analyses.

The safety information is presented for the overall study, not by treatment group. It therefore cannot support a comparative safety assessment. The record does not report deaths, which is different from reporting that no deaths occurred. Nor does the aggregate adverse-event information establish that events were caused by study treatment.

These are limitations of the registry information available for statistical interpretation. They do not establish what may be documented in other trial materials, and no conclusions about unreported data or analyses can be drawn from the registry entry.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer — NCT00085631.
• Registry record last updated 2013-09-17; status last verified 2013-07.
• Results first posted 2013-09-17.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry describes a randomized, unmasked, parallel-group phase III trial comparing cisplatin and radiation therapy with versus without hyperthermia for locally advanced cervical cancer. Enrollment is recorded as 101; the trial status is terminated. The primary outcome is tumor response, defined as complete or partial response by RECIST criteria. Its title gives an assessment timing of 4-6 weeks post treatment, while the timeframe field says 3 months from start of therapy.

The record lists 4 outcome measures and 0 analyses. It does not report primary response results, arm-specific outcome data, or a statistical comparison. Overall adverse-event information is reported, but not by treatment arm. The reason for termination, analysis populations, missing-data methods, and statistical analysis plan are not reported in the registry record. The posted entry therefore documents the intended comparison and selected trial details, but does not provide the primary results needed to interpret the treatment contrast.