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 A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma (NCT02805179), a na phase 2 study. The primary outcome is Overall Survival at 12 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02805179 |
| Phase | Phase 2 |
| Condition | Glioma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 26 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Michigan Rogel Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The primary endpoint population is described as all eligible patients who completed dose-intensified chemoradiation. The study concerns patients with newly diagnosed glioblastoma; the condition is recorded as glioma. The registry record lists enrollment of 26, but does not report how many enrolled patients met the endpoint population definition or completed chemoradiation.
Intervention
The study evaluated high-dose radiation based in part on advanced imaging, given with concurrent temozolomide. The arm description also says that adjuvant temozolomide was to be given four weeks after chemoradiation. Further details of radiation delivery, dose, treatment duration, and adjuvant treatment are not reported in the registry record.
Comparator
This was a single-group study, with allocation recorded as not applicable and masking recorded as none. The registry record does not describe a concurrent control group or a randomized comparison. Consequently, the study does not directly compare the intervention with another treatment within its design.
Primary question
The primary endpoint asks what percentage of the defined patient population was alive 12 months after completion of chemoradiation. This is an overall-survival measure at a specified time point. The endpoint’s numerical estimate and 95% confidence interval are not reported in the registry record, so the result’s magnitude and precision cannot be assessed from that record.
3. Trial Design
This is a phase II, single-group study sponsored by the University of Michigan Rogel Cancer Center. Its title describes high-dose chemoradiation using biologically based target-volume definition in patients with glioblastoma. The registry record lists enrollment of 26 and describes high-dose radiation based in part on advanced imaging, with concurrent temozolomide. The arm description adds adjuvant temozolomide four weeks after chemoradiation.
The study began on 2016-09-22, reached primary completion on 2020-02-06, and is recorded as completed. Allocation is listed as not applicable, and masking is listed as none. The model is single group; there is no randomized allocation or concurrent control group described in the record. Thus the design can describe outcomes among the treated study population, but it cannot by itself separate treatment effects from other explanations for observed outcomes.
The primary outcome is overall survival at 12 months after completion of chemoradiation. Its stated population is all eligible patients who completed dose-intensified chemoradiation. The registry record also lists secondary outcomes concerning median progression-free survival, change in tumor volume from baseline to mid-radiation treatment at week 4, deterioration in quality of life, and the location of failure. Numerical results and detailed analysis descriptions for these outcomes are not reported in the registry record.
The registry record does not report the treatment dose or a detailed protocol for defining target volumes. It also does not report the sample-size justification, stopping rules, interim analyses, or a prespecified statistical analysis plan. The absence of those details limits assessment of how the trial was planned and how its endpoint analyses were to be conducted.
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 | All Participants |
|---|---|
| STARTED | 26 |
| Eligible Patients That Started Dose-intensified Chemo-radiation | 23 |
| Subset of Participants, Boosted to Both High B-value Diffusion and Perfusion | 13 |
| COMPLETED | 23 |
| NOT COMPLETED | 3 |
Analysis population for the primary outcome, as defined in the registry: all eligible patients who completed dose-intensified chemo-radiation
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 | High Dose Chemoradiation |
|---|---|---|
| Participants analysed | 26 | |
| Age, Continuous | years | 62 (50 to 77) |
| Sex: Female, Male: Female | Participants | 10 |
| Sex: Female, Male: Male | Participants | 16 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 26 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 24 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival at 12 Months, measured over 12 months after completion of chemoradiation.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of patients alive at 12 months after completion of chemoradiation. The registry identifies the measure as overall survival at 12 months and specifies the population as all eligible patients who completed dose-intensified chemoradiation. The endpoint therefore concerns survival status at a fixed time after treatment, rather than the time until death across the entire follow-up period.
As a general statistical concept, a fixed-time survival percentage offers an interpretable snapshot: it describes the proportion of a defined group known to be alive at the chosen time point. It does not, on its own, describe when deaths occurred or the pattern of survival over follow-up. A confidence interval communicates uncertainty around an estimated percentage; its width depends on the information available and the variability in the data.
The endpoint is relevant to the study’s stated question about survival after chemoradiation. However, the registry record does not report the percentage, its 95% confidence interval, the number included in the endpoint analysis, or how incomplete follow-up and missing survival status were handled. The endpoint’s observed value and precision therefore cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies overall survival at 12 months after completion of chemoradiation as the primary endpoint. It describes the endpoint as a percentage among all eligible patients who completed dose-intensified chemoradiation. The numerical endpoint estimate and its stated 95% confidence interval are not reported in the registry record. Without those results, it is not possible to describe the observed survival percentage, judge its precision, or assess how closely the estimate is compatible with different possible underlying values.
The distinction between the overall enrollment and the primary endpoint population matters. Enrollment is listed as 26, while the endpoint population is restricted to eligible patients who completed chemoradiation. The number meeting that definition is not reported in the registry record. Enrollment alone therefore cannot establish the denominator used for the primary endpoint, nor can it show whether all enrolled patients contributed to that analysis.
The design is single group and does not include a randomized control comparison. An outcome observed in this cohort could describe what happened to the participants included in the analysis, but it cannot establish what would have happened to comparable patients under a different treatment. Differences from outcomes in another population or study could reflect patient characteristics, eligibility, follow-up, treatment delivery, or other factors, rather than the intervention alone. No external comparison is specified in the record.
The secondary outcomes listed include median progression-free survival, tumor-volume change at mid-radiation treatment, quality-of-life deterioration, and failure location. Their result values and detailed analysis methods are not reported in the registry record. They therefore cannot be used to corroborate or qualify the primary endpoint.
The safety summary records serious adverse events among all enrolled patients, along with other adverse events and deaths. These are descriptive counts in the registry record and should not be treated as evidence that the intervention caused every event or death. The record does not provide the information needed to connect individual events to treatment, to compare risks against a control group, or to assess how event collection and follow-up affected the reported counts.
Overall, the available registry information identifies the question and design but does not provide the primary result. No conclusion about the size or precision of the endpoint estimate can be drawn from the record, and the single-group design would limit causal interpretation even if an outcome estimate were available.
9. Statistical Methods Explained
The record identifies a percentage as the primary outcome measure and a 95% confidence interval as its dispersion measure. It does not report the endpoint estimate or interval, or describe the calculation method. The statistical concepts below are general explanations; they do not establish which procedures were used in this study.
What does a confidence interval convey?
In general, a confidence interval expresses the uncertainty associated with an estimate. For a percentage, it gives a range of values that are reasonably compatible with the observed data under the method’s assumptions. A narrower interval usually indicates greater precision, while a wider interval indicates greater uncertainty. The interval is not a guarantee that the true value lies within its limits, and it does not indicate whether a treatment caused the outcome. Because the registry record does not report the primary estimate or its interval, neither its precision nor the range of compatible values can be evaluated.
What does the fixed-time endpoint capture?
Overall survival at 12 months is a status measure at a specified time after completion of chemoradiation. As a general concept, a fixed-time percentage can be easy to interpret, but it compresses follow-up information into a single time point. It does not show the timing of events before that point or describe survival after it. Interpretation also depends on who is included in the analysis and how survival status is established. The registry defines the intended population as all eligible patients who completed dose-intensified chemoradiation, but the number analyzed and the handling of incomplete follow-up are not reported in the registry record.
Why does the single-group design matter?
In a single-group study, outcomes are observed among participants receiving the study regimen without a concurrent randomized comparison. As a general statistical principle, an observed outcome rate can describe the study cohort, but it does not estimate the contrast between the regimen and an alternative assigned under the same conditions. Patient selection, disease characteristics, care outside the study, and follow-up can influence observed outcomes. Without a control group, these explanations cannot be separated from a treatment effect using the study design alone. The registry record lists allocation as not applicable and the model as single group.
What can the adverse-event counts tell readers?
Adverse-event counts describe events recorded in the study population, subject to the record’s definitions and collection procedures. They are not automatically rates attributable to treatment. A causal interpretation would require information about event timing, attribution, observation periods, and relevant comparison data. Those details are not reported in the registry record. Serious and other adverse events are distinct categories in the posted summary, and the counts should be read within those categories rather than combined or treated as interchangeable.
What analysis details remain unknown?
The registry record does not report the statistical analysis plan, the method for calculating the primary estimate or confidence interval, the handling of censoring or missing outcomes, or any interim analysis. It also does not report a sample-size justification. These omissions prevent assessment of whether the chosen analysis followed a prespecified procedure, how sensitive it might be to incomplete data, or what precision was anticipated. General statistical principles cannot fill in those study-specific details.
The record lists several secondary outcomes. When studies examine multiple outcomes, interpretation can be affected by the number of statistical questions considered and whether any adjustment or hierarchical strategy was planned. This is a general concern about multiplicity, not a claim that a particular adjustment was or was not used in the trial. The registry record does not report a multiplicity strategy or detailed results for the secondary outcomes.
10. Multiplicity, Missing Data and Analysis Populations
The registry record names one primary endpoint and lists secondary outcomes relating to progression-free survival, tumor-volume change, quality of life, and failure location. It does not report the detailed statistical analysis plan, whether these outcomes were tested formally, or whether any multiplicity adjustment or prespecified hierarchy was used. When several outcomes are examined, chance findings can become more likely if each is treated as a separate confirmatory test. This general issue cannot be resolved from the information in the record.
The primary endpoint population is described as all eligible patients who completed dose-intensified chemoradiation. The registry record does not give the number included in that population or the number with evaluable survival status. It does not report how missing status, incomplete follow-up, or other departures from the endpoint population definition were handled. The enrollment figure cannot substitute for these analysis details because the defined endpoint population is narrower than all enrolled patients.
The record also does not report whether analysis was based on all enrolled participants, only eligible participants, treatment completers, or another prespecified group for outcomes beyond the primary endpoint. Details of censoring, exclusions, and follow-up are not reported in the registry record. These gaps make it difficult to assess how the analysis population was formed and whether missing information could affect interpretation.
As a general principle, missing-data methods and analysis populations should be specified because different choices can lead to different estimates. No particular method can be attributed to this study based on 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 |
|---|---|---|---|
| All Enrolled Patients | 8 | 26 | 30.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| All Enrolled Patients | 21 of 26 |
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 |
|---|---|
| All Enrolled Patients | 25 of 26 |
Most frequent serious adverse event terms
| Event term | Organ system | All Enrolled Patients |
|---|---|---|
| Nervous system disorders - Other | Nervous system disorders | 2 of 26 |
| Confusion | Psychiatric disorders | 2 of 26 |
| Thromboembolic event | Vascular disorders | 2 of 26 |
| Nausea | Gastrointestinal disorders | 1 of 26 |
| Localized edema | General disorders | 1 of 26 |
| Urinary tract infection | Infections and infestations | 1 of 26 |
| Wound infection | Infections and infestations | 1 of 26 |
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | 1 of 26 |
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | 1 of 26 |
| Headache | Nervous system disorders | 1 of 26 |
Most frequent non-serious adverse event terms
| Event term | Organ system | All Enrolled Patients |
|---|---|---|
| Fatigue | General disorders | 20 of 26 |
| Nausea | Gastrointestinal disorders | 11 of 26 |
| Constipation | Gastrointestinal disorders | 9 of 26 |
| Headache | Nervous system disorders | 8 of 26 |
| Platelet count decreased | Investigations | 7 of 26 |
| Dizziness | Nervous system disorders | 7 of 26 |
| Insomnia | Psychiatric disorders | 7 of 26 |
| Alopecia | Skin and subcutaneous tissue disorders | 6 of 26 |
| General disorders and administration site conditions - Other | General disorders | 5 of 26 |
| Pain | General disorders | 5 of 26 |
Serious events with the highest arm-level rate: nervous system disorders - other (7.7%), confusion (7.7%), thromboembolic event (7.7%), nausea (3.8%), localized edema (3.8%).
The posted safety summary lists all enrolled patients as the group at risk for adverse events. It records 8 patients with serious adverse events among 26 at risk, 25 with other adverse events among 26 at risk, and 21 deaths. These are separate reported figures; they should not be added together or assumed to describe mutually exclusive groups.
The serious adverse-event terms with listed percentages are nervous system disorders - other and confusion at 7.7% each, thromboembolic event at 7.7%, and nausea, localized edema, and urinary tract infection at 3.8% each. The registry record does not provide further details about event timing, severity within each term, recurrence, or attribution to study treatment.
The death count is not, by itself, a treatment-related death count. The record does not say that the deaths were caused by the intervention, nor does it give the relationship between deaths and the primary endpoint analysis. The summary also does not provide a control group for comparison. These figures describe the recorded safety experience; they do not establish comparative safety or causation.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this completed phase II study evaluated high-dose radiation with concurrent temozolomide in patients with newly diagnosed glioblastoma. It specifies a single-group design, enrollment of 26, and overall survival at 12 months after completion of chemoradiation as the primary endpoint. The arm description also includes planned adjuvant temozolomide four weeks after chemoradiation.
The record does not report the primary endpoint estimate or its 95% confidence interval. Accordingly, it does not support a description of the observed 12-month survival percentage or how precisely it was estimated. The record also does not report enough information to determine the endpoint analysis denominator or how incomplete follow-up was handled.
Even a reported outcome percentage from this design would describe the analyzed study population, not a causal contrast against another treatment. Because there is no concurrent randomized comparator, the study cannot establish from its design alone what would have occurred to similar patients under an alternative approach. Comparisons with other studies would also require careful attention to differences in eligibility, clinical setting, follow-up, and outcome definitions.
The adverse-event summary describes recorded events and deaths, but does not establish that the intervention caused them. The listed secondary outcomes could provide additional clinical context if their results and methods were available; those details are not reported in the registry record.
In short, the registry record documents the study question, design, and selected safety counts, but the central efficacy result is unavailable in the record. It should not be read as evidence for or against treatment effectiveness. It is a description of the study’s intended endpoint and design, with important outcome and analysis details unreported.
13. Why This Trial Matters Statistically
This study raises a useful statistical question about how outcomes are interpreted when a treatment strategy is evaluated without a concurrent control group. A single-group design can document outcomes in a defined cohort, but it does not directly estimate the difference between treatments. Keeping that distinction clear is essential when reading a survival percentage or adverse-event count.
The primary endpoint is a fixed-time overall-survival percentage after completion of chemoradiation. That endpoint is readily stated in clinical terms, but interpretation depends on the population actually analyzed, follow-up completeness, and the uncertainty around the estimate. Here, the registry record names the endpoint and its intended population but does not report the estimate, interval, analysis denominator, or missing-data handling. The absence of those details prevents evaluation of precision and analysis completeness.
The record also illustrates why safety summaries need careful reading. A serious-event count, an other-event count, and a death count describe different aspects of observed experience. Without timing, attribution, and a comparison group, they do not establish that treatment caused an event or that risk differs from another approach.
More broadly, the registry information distinguishes what was planned from what can be interpreted. It describes the regimen and outcomes of interest, while leaving the primary numerical result and several analysis details unreported. Recognizing that boundary helps readers avoid treating a completed trial record as though completion itself provides evidence of an outcome. The statistical value of the record is in its description of the question and design, alongside an explicit view of the information needed for stronger interpretation.
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 central limitation for interpreting efficacy is that the primary endpoint result and its 95% confidence interval are not reported in the registry record. The number of eligible patients who completed dose-intensified chemoradiation and contributed to the endpoint analysis is also not reported. Therefore, neither the estimate nor its precision and denominator can be assessed.
The single-group design has no concurrent randomized control group. It can describe outcomes in the study cohort but cannot establish a treatment contrast or distinguish treatment effects from other influences on outcome. Allocation is recorded as not applicable and masking as none.
The registry record does not report detailed radiation dosing, target-volume procedures, adherence, treatment completion, follow-up duration beyond the stated endpoint timing, or the handling of missing survival status. A sample-size justification, interim analyses, and a prespecified statistical analysis plan are also not reported in the registry record. These gaps constrain assessment of design assumptions and analysis choices.
Although several secondary outcomes are listed, their numerical results and detailed methods are not reported in the registry record. Multiplicity handling is not reported. The safety summary gives counts and selected event percentages, but does not report event attribution, timing, or a comparative safety analysis. These limitations mean the available record supports a description of the study design and reported safety figures, not a complete evaluation of efficacy or comparative harms.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma — NCT02805179.
- Registry record last updated 2021-04-15; status last verified 2021-03.
- Results first posted 2021-04-15.
- 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
NCT02805179 is a completed phase II, single-group study sponsored by the University of Michigan Rogel Cancer Center. The registry record lists enrollment of 26 and describes high-dose radiation based in part on advanced imaging, concurrent temozolomide, and planned adjuvant temozolomide four weeks after chemoradiation. The primary endpoint is overall survival at 12 months after completion of chemoradiation among all eligible patients who completed dose-intensified chemoradiation.
The record lists secondary outcomes involving progression-free survival, tumor-volume change, quality-of-life deterioration, and failure location. It also records serious and other adverse events and deaths among all enrolled patients. The primary endpoint result, its 95% confidence interval, the endpoint analysis denominator, and key analysis details are not reported in the registry record. The single-group design does not provide a randomized treatment comparison.