Hypofractionated IMRT With Temozolomide for HGG: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Hypofractionated IMRT With Temozolomide for HGG (NCT02082119), a na na study. The primary outcome is Progression Free Survival (PFS).

2. Clinical Question

The study concerns patients with newly diagnosed high grade glioma after surgery. Its stated aim was to evaluate the safety and feasibility of hypofractionated intensity-modulated radiotherapy in addition to concomitant and adjuvant chemotherapy. The registry names progression-free survival, overall survival and toxicity among the primary endpoints in the brief summary, and describes quality of life as a secondary objective.

The posted primary outcome is progression-free survival at 1 year, recorded as a count of participants. The registry’s definition includes radiographic evidence of progression, new lesions, progression of non-measurable disease, or clinical deterioration attributed to the tumor under specified conditions. It also lists quality of life after surgery and during or after treatment as a secondary outcome. The posted record does not give a quality-of-life result or a separate overall-survival result.

This is a single-group study rather than a randomized comparison. Consequently, its central question is descriptive: what outcomes and safety counts were recorded for the treated group? The design does not directly estimate how outcomes would differ under another treatment or under no treatment. The registry lists 82 participants as the enrollment, but the primary outcome population is described only as patients with newly diagnosed high grade glioma who were analysed; the number analysed for that endpoint is not reported in the registry record.

3. Trial Design

The registry identifies this as a completed, single-group study with 82 participants enrolled. Allocation is listed as NA, and masking is listed as none. The phase is listed as NA. These labels describe the registry entry; they do not establish additional details about the study procedures.

The study started in 2013-07 and reached primary completion in 2016-05. The named intervention is hypofractionated IMRT. The brief summary describes its use with concomitant and adjuvant chemotherapy for patients with newly diagnosed high grade glioma after surgery. The arm description begins to specify a radiation regimen, but the posted text is incomplete, so the full treatment schedule is not reported in the registry record.

The registry’s primary outcome is progression-free survival, with a timeframe of 1 year and a unit of participants. Its definition includes radiographic and clinical criteria for progression. The brief summary also names overall survival and toxicity as primary endpoints, but the posted outcome information does not provide separate results for those endpoints. Quality of life is listed as a secondary outcome, described in relation to surgery and chemotherapy; a result for that outcome is not reported in the registry record.

A single-group design can describe outcomes and adverse-event counts among participants who received the study intervention. It does not provide a contemporaneous randomized control group for estimating a treatment contrast. The registry does not report a comparator, randomization procedure, or masking beyond the listed entries. Further details about eligibility criteria, treatment delivery, follow-up procedures, and the analysis population are not reported in the registry record.

The status is recorded as completed, but completion alone does not establish that every planned outcome was reported or that all enrolled participants contributed to every analysis. The number included in the PFS analysis and the handling of participants with incomplete follow-up are not reported in the registry record.

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

Analysis population for the primary outcome, as defined in the registry: Patients with newly diagnosed high grade glioma were analysed.

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 Progression Free Survival (PFS), measured over 1 year.

Progression-free survival (PFS) describes the time or status of participants before disease progression or death, depending on the endpoint definition and analysis. In this registry entry, the posted measure is a count of participants, with a timeframe of 1 year. Its definition identifies progression using radiographic findings, new or progressing lesions, or definite clinical deterioration attributed to the tumor, subject to the conditions stated in the record.

PFS is used in cancer studies because it captures whether disease has progressed during follow-up, rather than relying only on survival. The endpoint can therefore summarize disease control over a specified period. That general rationale does not establish how PFS was analyzed in this study. The registry record does not report a time-to-event estimate, a confidence interval, a comparison, or the statistical method used to derive the posted endpoint.

The outcome population is described as patients with newly diagnosed high grade glioma who were analysed, but the analyzed count is not reported in the registry record. The posted information also does not provide the number meeting the PFS definition at 1 year. As a result, the endpoint’s definition and timeframe are available, but its numerical result and precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the study as single group, with allocation listed as NA and masking listed as none. Those entries indicate that the record does not describe a randomized, masked comparison. They do not supply a full account of how participants were assigned to treatment, how outcome assessments were conducted, or what safeguards were used against bias. Those details are not reported in the registry record.

What a single-group outcome can show

In a single-group study, observed outcomes describe the participants who received the study intervention and were included in the relevant analysis. The result can be useful for documenting what happened in that group. Without a concurrent comparator, however, the outcome does not isolate the effect of the intervention from other influences. Differences in patient characteristics, disease course, co-interventions, follow-up and clinical practice can all contribute to observed outcomes. This is a general limitation of non-comparative designs, not a claim about any particular participant in this study.

The registry lists 82 participants enrolled, but does not report how many contributed to the PFS analysis. Enrollment and analysis population are not necessarily identical: participants can be unavailable for follow-up or lack information needed for a particular outcome. Whether that occurred here, and how it was handled, is not reported in the registry record.

How to understand PFS

PFS is commonly analyzed as a time-to-event outcome, where the event is disease progression or death according to the protocol definition. A time-to-event analysis can account for differing follow-up by including participants until an event or the last time they are known to be event-free. Participants without an observed event at the end of available follow-up are typically treated as censored under a specified method. The method and censoring rules used in this study are not reported in the registry record.

The posted endpoint is expressed as a count of participants at 1 year. A count alone does not show how follow-up time was handled or whether the figure is a simple status count or derived from a time-to-event analysis. The record does not post the PFS count itself, a survival estimate, a confidence interval, or a test result. A confidence interval, in general, describes the statistical uncertainty around an estimate under the assumptions of the analysis; without an estimate and interval, the precision of the PFS result cannot be judged.

Analysis choices and uncertainty

Different statistical methods can address different questions. A proportion can describe the share of participants experiencing an event by a specified time, while survival methods use event timing and account for incomplete follow-up under their assumptions. Adjusted analyses can account for measured participant characteristics, but they require a stated model and appropriate data. No PFS analysis method, adjustment strategy, model assumptions, or confidence interval is reported in the registry record.

For counts of events, uncertainty depends in part on the number of participants and the frequency of the outcome. When counts show more variability than a simple model expects, over-dispersion can make conventional uncertainty estimates too narrow; methods designed to allow extra variation may then be appropriate. This is a general statistical consideration. The registry does not provide a count of PFS events or a model specification that would allow over-dispersion to be assessed.

The registry’s sample-size planning assumptions describe a planning illustration based on a stated fraction of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect is framed as a fraction of the observed effect. Such calculations are planning illustrations, not evidence that the study was designed with those assumptions, and not observed power. In particular, an equal-allocation, two-arm illustration does not turn this single-group study into a randomized two-arm trial. No trial-specific sample-size justification or power calculation is reported in the registry record.

Multiplicity arises when several outcomes or statistical hypotheses are assessed. Testing many hypotheses can increase the chance of at least one nominally significant result. The registry names PFS, overall survival and toxicity in its brief summary, and lists quality of life as a secondary outcome, but the analysis plan and any multiplicity procedure are not reported. It is therefore not possible to determine whether outcomes were tested, how they were prioritized analytically, or whether any adjustment was planned.

These methodological distinctions matter because a precise estimate is not the same as a causal estimate, and a stated objective is not the same as a reported result. For this registry entry, the posted design and endpoint definition can be described, but the missing numerical outcome and analysis details prevent evaluation of the size and uncertainty of the PFS result.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("High Grade Glioma")
n      <- c(82)
events <- c(82)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  High Grade Glioma  82  82  100.0  95.6  100.0  95.5  100.0  95.7  100.0

11. Multiplicity, Missing Data and Analysis Populations

The registry names PFS, overall survival and toxicity in its brief summary, and lists quality of life as a secondary outcome. It does not report a statistical analysis plan describing how these outcomes were prioritized, whether multiple hypotheses were tested, or whether any adjustment for multiplicity was planned. When several outcomes are examined, the chance of at least one apparently notable finding can increase; adjustment methods are one way to address that issue. This is a general statistical point, not a statement about an analysis conducted in this study.

The record identifies a PFS endpoint at 1 year but does not report its numerical result, the analyzed population size, or the treatment of incomplete follow-up. The handling of missing outcome data, censoring rules, and any sensitivity analyses are not reported in the registry record. The population is described as patients who were analysed, but the criteria defining that analysis population are not given.

These omissions limit assessment of whether the posted outcomes represent all enrolled participants and how robust any estimate would be to missing observations. The record also does not report whether any interim analyses occurred or how they might have been handled. No such procedures should be inferred from the study’s completion status or stated endpoints.

12. 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.

The serious adverse-event entry lists 82 participants at risk and 0 affected. The separate other-adverse-event entry also lists 82 participants at risk and 0 affected. These are registry counts for the High Grade Glioma group. They describe what was entered for those categories, not a complete account of every possible symptom or event during care.

The list of top serious-event terms is empty. The deaths field has no numeric value; deaths are therefore not reported in the registry record, rather than recorded as zero. The record does not give further detail about event definitions, collection methods, reporting windows, severity grades, or whether events were judged related to treatment. It also does not explain the scope of the other-adverse-event category.

A zero count in a posted category should not be interpreted as proof that no harm occurred. It can only be read as the count recorded for that category in this entry. With no additional event detail or denominator information for each safety analysis beyond the listed at-risk counts, the completeness and precision of safety estimates cannot be assessed.

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

The registry record documents a completed single-group study of hypofractionated IMRT with concomitant and adjuvant chemotherapy for newly diagnosed high grade glioma. It records an enrollment of 82 participants and defines PFS at 1 year as the primary outcome measure. It also records safety counts for serious and other adverse events. These details establish the study’s stated design and the outcomes it intended to assess.

The record does not post the numerical PFS result, a separate overall-survival result, or a quality-of-life result. It therefore cannot establish what proportion of participants remained progression-free, how long participants remained progression-free, or how uncertain an estimated outcome might be. The stated purpose of evaluating safety and feasibility does not substitute for outcome findings.

Because the study is single group, its posted information cannot determine whether the intervention caused an observed outcome or how outcomes compare with another treatment. A control group and an appropriate comparative analysis would be required to estimate that contrast. Even a complete single-group outcome report would primarily describe outcomes in the treated participants rather than answer the comparative question.

The safety counts should be interpreted narrowly: the registry records 0 affected among 82 at risk in each of the serious and other adverse-event categories. This does not demonstrate the absence of adverse effects, and the deaths field is not reported. The entry does not provide enough information to judge the completeness of event surveillance or quantify safety uncertainty.

In short, the record conveys design, endpoint definitions and posted safety counts, but the absence of numerical PFS and other outcome findings limits conclusions about clinical outcomes. It neither demonstrates benefit nor establishes lack of benefit. The results that are not reported remain unknown from the registry record.

14. Why This Trial Matters Statistically

Statistically, this trial illustrates why the study design and the reported outcome information need to be considered together. The record describes a single-group study and names PFS at 1 year, but does not include the numerical PFS outcome or an uncertainty estimate. A well-defined endpoint is important, yet its definition alone cannot tell readers the observed outcome or how precisely it was estimated.

The endpoint definition includes radiographic and clinical criteria. Such definitions matter because they determine which observations count as progression. In general, consistent application of criteria and transparent reporting of follow-up help readers understand an outcome. The registry entry does not describe assessment procedures, adjudication, or the analysis method, so those aspects cannot be evaluated.

The study also highlights the distinction between description and comparison. Single-group data can report what was recorded among treated participants. They do not provide a randomized contrast that separates treatment effects from other influences. This distinction remains important even when the intended outcomes are clinically meaningful and follow-up is completed.

Finally, the safety counts demonstrate why a zero in an event category must be read in context. The registry records zero affected for both serious and other adverse events, while details about surveillance and the deaths field are not reported. Clear denominators, event definitions, and complete outcome reporting are needed to interpret such counts responsibly.

These statistical considerations are useful beyond this study: readers should distinguish endpoint definitions from results, enrollment from analysis populations, and descriptive outcomes from treatment effects. In this record, that discipline keeps conclusions aligned with the information actually posted.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main trial-specific limitation is the absence of a posted numerical result for the primary PFS outcome. Although the registry provides a timeframe of 1 year and a detailed progression definition, it does not give the number of participants meeting the endpoint or an estimate with uncertainty. The number included in the PFS analysis is also not reported in the registry record.

The design is single group, with no comparator listed. This prevents a direct estimate of how outcomes differ from another treatment strategy. The registry lists allocation as NA and masking as none, but does not provide further methodological detail that would permit assessment of outcome-assessment procedures or other potential sources of bias.

The brief summary names overall survival and toxicity as primary endpoints, but separate outcome findings for overall survival are not reported. Quality of life is listed as a secondary outcome without a posted result. For safety, the event counts are recorded, but the deaths field, event-collection details, and other information needed to assess completeness are not reported.

The record does not state how missing data, loss to follow-up, censoring, multiplicity, or analysis populations were handled. It also does not report a trial-specific sample-size justification or statistical analysis plan. The incomplete arm description further limits understanding of the full treatment schedule. These gaps mean that the registry entry supports a limited description of the trial, not a full appraisal of its outcome estimates or analytical validity.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Hypofractionated IMRT With Temozolomide for HGG — NCT02082119.
• Registry record last updated 2020-10-12; status last verified 2020-09.
• Results first posted 2020-10-12.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

This completed study enrolled 82 participants and is recorded as single group, with allocation listed as NA and masking listed as none. It evaluated hypofractionated IMRT with concomitant and adjuvant chemotherapy in patients with newly diagnosed high grade glioma after surgery.

The registry identifies PFS at 1 year as the primary outcome measure and describes criteria for progression. Its brief summary also names overall survival and toxicity as primary endpoints, and quality of life as a secondary objective. Numerical results for PFS, overall survival and quality of life are not reported in the registry record.

The safety entries list 0 affected among 82 at risk for serious adverse events and 0 affected among 82 at risk for other adverse events. The deaths field is not reported. Analysis methods, missing-data handling, and the number analyzed for PFS are also not reported in the registry record.