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 Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients (NCT04398199), a na phase 2 study. The primary outcome is Presence or Absence of In-Field Progression.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04398199 |
| Phase | Phase 2 |
| Condition | Nonsmall Cell Lung Cancer, Stage II, Nonsmall Cell Lung Cancer Stage III |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Wake Forest University Health Sciences |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with stage II or stage III nonsmall cell lung cancer who declined or were ineligible for surgery or chemotherapy, according to the official title. The registry lists enrollment as 1. It does not report participant-level characteristics, so the enrolled participant’s clinical profile cannot be described from this record.
Intervention
Participants were to receive hypofractionated radiation therapy. The registry describes a planning approach that gives more radiation to the more difficult-to-control parts of the tumor than to lower-risk areas, while protecting nearby organs. A radiation boost is also listed as an intervention.
Comparator
This was a single-group study, not a randomized comparison. There was no concurrent control group. The primary outcome description proposed comparison with a historical control proportion of 0.5, but no primary outcome data are available in the registry record.
Primary question
The primary question was whether participants had in-field progression at 2 years. In-field progression was defined as growth of targeted lesions beyond the treated volume. The registry says the study was terminated early because of low accrual and that outcome measure data are not available.
3. Trial Design
This was a phase II, single-group study sponsored by Wake Forest University Health Sciences. Its official title describes hypofractionated radiotherapy alone for people with locally advanced nonsmall cell lung cancer who declined or were ineligible for surgery or chemotherapy. The conditions listed are stage II and stage III nonsmall cell lung cancer. The registry identifies the study as terminated and lists enrollment as 1.
All participants were to receive hypofractionated radiation therapy. The intervention description says radiation planning would give the more difficult-to-control parts of tumors a little more radiation each day than lower-risk areas. Radiation boost is also listed. The registry summary describes the approach as allowing an extra dose to the tumor while protecting nearby organs. These descriptions identify the intended treatment approach, but do not establish how much treatment the enrolled participant received.
There was no allocation to separate study groups, and the design is identified as single-group with no masking. Thus, the planned evaluation did not include a concurrent comparison arm. The primary outcome description instead proposed comparing the proportion with in-field progression at 2 years against a historical control proportion of 0.5. A historical benchmark is not the same as a group observed at the same time under the same study procedures, so it cannot provide the same type of direct comparison as a concurrent control.
The registry lists a start date of 2020-10-16 and a primary completion date of 2020-11-20. It reports early termination because of low accrual, with primary outcome data unavailable. The record names four secondary outcomes: grade 2 or higher toxicities, local progression, progression-free survival, and overall survival. It does not report results for these outcomes or give participant-level follow-up information.
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 | Hypofractionated Radiation Therapy |
|---|---|
| STARTED | 1 |
| COMPLETED | 1 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Study was terminated early due to low accruals, outcome measure data not available.
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 | Hypofractionated Radiation Therapy |
|---|---|---|
| Participants analysed | 1 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 1 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Presence or Absence of In-Field Progression, measured over At 2 years.
| 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 presence or absence of in-field progression at 2 years. The registry defines in-field progression as growth of targeted lesions beyond the treated volume. It defines the treated volume using the 28.75 Gy isodose line, identified as 50% of 57.5 Gy. Pathologic confirmation of progression was preferred. If biopsy was not feasible or safe, radiographic determination could be made by consensus of the Multidisciplinary Thoracic Oncology Program.
This endpoint focuses on whether tumor growth extends beyond the specified treated volume by the stated time point. A binary presence-or-absence outcome can be expressed as a proportion of participants experiencing the event, which is why the registry describes a planned comparison of that proportion with a historical control proportion of 0.5 using a one-sample z-test. In general, a clearly defined endpoint and assessment time help specify what an analysis is intended to measure. The registry record does not provide observed endpoint data, so it cannot show the proportion with in-field progression or how that proportion compares with the historical benchmark.
The endpoint description gives a preferred confirmation method and an alternative assessment process, but the record does not report how either was applied to the enrolled participant. It also does not report an endpoint result at 2 years. The registry explicitly attributes the absence of outcome measure data to early termination for low accrual.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a phase II study of hypofractionated radiotherapy alone, designed for people with locally advanced nonsmall cell lung cancer who declined or were ineligible for surgery or chemotherapy. It was a single-group study with no concurrent control arm. The stated primary question concerned in-field progression at 2 years, with a planned comparison against a historical control proportion of 0.5.
The key interpretive fact is that the registry lists enrollment as 1 and states that the study was terminated early because of low accrual. It also says primary outcome measure data are not available. Consequently, the posted record does not provide an observed estimate of in-field progression, and it does not show whether the study’s primary question was answered. No conclusion about the frequency of progression in the study group can be drawn from the endpoint description alone.
The record names four secondary outcomes: grade 2 or higher toxicities, local progression, progression-free survival, and overall survival. It does not report results for these outcomes. The analysis count in the record is 0. This means the registry record does not list analyses; it should not be interpreted as evidence that a particular statistical analysis found no effect or no events.
For the planned one-sample z-test, a result would ordinarily depend on the observed proportion and the amount of information available. Neither a primary outcome estimate nor an analysis result is reported. The historical benchmark of 0.5 is part of the stated analysis plan, not an observed result from this study. Without outcome data, there is no basis in the posted results for judging the direction, magnitude, or precision of any difference from that benchmark.
In general, a confidence interval describes a range of values reasonably compatible with the data under the assumptions of the analysis. No primary endpoint confidence interval is reported in the registry record. With only one participant listed, even outcome data from that participant would provide very little information about a proportion intended to characterize a broader population. This is a general statistical point, not a replacement for the missing outcome results.
The adverse-event fields report a very small group and list serious-event terms, but those entries do not supply a comparative safety estimate. No concurrent control group was included, and the record does not provide enough context to attribute an event to the intervention. The serious adverse event figures should therefore be read as sparse registry entries, not as a reliable estimate of treatment risk.
Overall, the record documents the study’s intended treatment and primary endpoint, its single-group design, and early termination for low accrual. It does not document an evaluable primary outcome or a reported analysis. The most defensible statistical interpretation is therefore that the planned efficacy question remains unanswered in the registry record, rather than that the treatment produced a particular outcome.
9. Statistical Methods Explained
The registry describes a single-group phase II study. In a single-group design, participants receive the study intervention without a concurrent control group. This can be useful for describing outcomes under the study approach, but it limits direct comparisons because there is no contemporaneous group receiving another intervention or usual care. Here, the primary outcome description proposed comparison with a historical control proportion of 0.5 rather than a concurrently enrolled control group.
What the planned one-sample test addresses
The primary endpoint is binary: presence or absence of in-field progression at 2 years. The registry says investigators planned to compare the proportion with any in-field progression at that time with a historical control proportion of 0.5 using a one-sample z-test. In general, a one-sample test evaluates whether an observed sample estimate is compatible with a stated reference value, under the test’s assumptions. A z-test for a proportion uses an approximation to the sampling distribution of a proportion. Its usefulness depends on having outcome observations and sufficient information for the approximation to be reasonable.
The registry gives the endpoint definition and proposed test, but the primary outcome data are unavailable. It therefore does not report an observed proportion, test statistic, p-value, or confidence interval for the primary endpoint. No conclusion about compatibility with the historical benchmark can be drawn from the stated plan alone. A planned test is not a result.
Why the historical comparison needs care
A historical control is a reference based on information from outside the current study rather than a group enrolled alongside it. In general, differences in participant selection, follow-up, outcome assessment, or other features can affect how well a historical proportion represents the comparison that would have been observed in a concurrent control group. The registry record identifies the benchmark but does not describe its source or provide details that would allow its comparability to be evaluated. It would be inappropriate to assume additional design features or justifications that are not reported.
The study is single-group and allocation is listed as not applicable. This is consistent with the absence of a randomized comparison. Without random assignment between groups, and without a concurrent control group, the record cannot support a randomized treatment contrast. Even if an outcome estimate had been available, interpretation would have depended on the endpoint data and the suitability of the historical reference.
Endpoint definition and assessment
The registry defines in-field progression as growth of targeted lesions beyond the treated volume, with the treated volume identified by the 28.75 Gy isodose line, or 50% of 57.5 Gy. It says pathologic confirmation was preferred and radiographic determination by multidisciplinary consensus could be used when biopsy was not feasible or safe. In general, explicit endpoint definitions and assessment procedures help reduce ambiguity about which events count. The record does not say how the endpoint was assessed for the enrolled participant, and it reports no endpoint result.
The specified 2-year time point matters because an event proportion depends on the period during which participants are observed. For outcomes with a fixed assessment time, participants need outcome ascertainment at that time or a stated method for handling incomplete follow-up. The registry record does not report follow-up completion or an analysis approach for participants without an assessment at 2 years. It states that outcome measure data are unavailable following early termination for low accrual.
Precision and sparse information
In general, an estimate based on very little information is imprecise: a broad range of underlying values may remain compatible with the observed data. Confidence intervals are one way to express that uncertainty. No primary endpoint estimate or interval is reported. The registry lists enrollment as 1, so the study record contains very limited enrollment information for estimating an event proportion across the intended population. Because outcome data are unavailable, even a participant-level outcome cannot be cited as an observed study result.
The registry does not report a sample-size justification, the assumptions used to select a target enrollment, or a detailed statistical analysis plan beyond the test named in the primary endpoint description. Any planning illustrations accompanying the statistical material are not observed power and do not repair the absence of outcome data. In general, sample-size planning explores how much information might be needed under specified assumptions; it does not demonstrate that a study with a particular enrollment has established an effect.
Other outcomes and analysis reporting
Four secondary outcomes are listed: grade 2 or higher toxicities, local progression, progression-free survival, and overall survival. The registry does not report results for these outcomes. It lists 5 outcome measures and 0 analyses. The record does not provide analysis populations, handling of missing observations, multiplicity procedures, or estimates and uncertainty measures for secondary outcomes. These omissions matter because outcome definitions and analysis choices affect how estimates are interpreted, but no unreported choice should be inferred.
In general, multiplicity refers to the interpretive issue that arises when several outcomes or statistical tests are considered. Looking at multiple results can increase the chance of at least one apparently notable finding, depending on the setting and analysis plan. A prespecified approach can clarify how such results are to be interpreted. The registry record does not report a multiplicity strategy. Since no analyses are listed, there are no reported secondary analyses to interpret or adjust.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures: the primary endpoint of in-field progression and four secondary outcomes. Those secondary outcomes are the proportion experiencing grade 2 or higher toxicities, the proportion experiencing local progression, progression-free survival, and overall survival. The record lists 0 analyses and does not report results for the secondary outcomes.
In general, when a study evaluates multiple outcomes or performs multiple statistical tests, multiplicity can affect how evidence is interpreted. A prespecified plan may identify a primary outcome, set out the role of secondary outcomes, and state whether or how statistical error is controlled. The registry identifies a primary endpoint and names the secondary outcomes, but a multiplicity strategy is not reported in the registry record. No procedure should be assumed.
The record says primary outcome data are unavailable because the study was terminated early for low accrual. It does not report whether the enrolled participant completed outcome assessments, how missing observations would have been handled, or what analysis population was intended. There are no reported participant-level outcome data from which to assess missingness or follow-up completeness. The planned 2-year primary endpoint makes the absence of reported follow-up information particularly relevant, but the record does not give details about the participant’s follow-up.
The registry does not report a statistical analysis population, an approach to censoring for time-to-event outcomes, or procedures for incomplete data. Such methods are general considerations for outcomes like progression-free survival and overall survival; they should not be attributed to this study without documentation. The absence of these details, together with the lack of outcome data and analyses, means the secondary outcomes cannot be statistically interpreted from 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 |
|---|---|---|---|
| Hypofractionated Radiation Therapy | 1 | 1 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Hypofractionated Radiation Therapy | 1 of 1 |
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 |
|---|---|
| Hypofractionated Radiation Therapy | 1 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | Hypofractionated Radiation Therapy |
|---|---|---|
| Acute kidney injury | Renal and urinary disorders | 1 of 1 |
| Hyperglycemia | Metabolism and nutrition disorders | 1 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Hypofractionated Radiation Therapy |
|---|---|---|
| Skin ulceration | Skin and subcutaneous tissue disorders | 1 of 1 |
| Constipation | Gastrointestinal disorders | 1 of 1 |
| Fever | General disorders | 1 of 1 |
| Sepsis | Infections and infestations | 1 of 1 |
| Hip fracture | Injury, poisoning and procedural complications | 1 of 1 |
| Fatigue | General disorders | 1 of 1 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 1 |
| Gastrointestinal disorder, other | Gastrointestinal disorders | 1 of 1 |
| Blood and lymphatic disorders, other | Blood and lymphatic system disorders | 1 of 1 |
Serious events with the highest arm-level rate: acute kidney injury (100.0%), hyperglycemia (100.0%).
The registry reports one participant at risk for serious adverse events and one affected, one participant at risk for other adverse events and one affected, and one death in the hypofractionated radiation therapy group. It also lists acute kidney injury and hyperglycemia as serious-event terms, each with a reported 100.0% figure. These are sparse entries from a group with enrollment listed as 1; they should not be treated as stable estimates of event frequency in a broader population.
The record does not establish from these figures whether an event was caused by the intervention, nor does it provide the clinical context needed to interpret the terms. The listed counts do not establish whether the serious-event entries, other adverse event entry, and death refer to overlapping records or describe distinct events. They should not be added together to infer a total number of affected participants. No comparison with another treatment group is available because this was a single-group study.
In general, adverse-event counts describe events recorded under a study’s reporting framework; they do not by themselves establish causation. With enrollment listed as 1 and no concurrent control group, these figures cannot provide a comparative safety estimate. The registry record does not report further detail that would resolve attribution or context.
12. What the Result Does, and Does Not, Mean
The registry establishes that a phase II study of hypofractionated radiotherapy alone was undertaken for people with locally advanced nonsmall cell lung cancer who declined or were ineligible for surgery or chemotherapy. Its intended primary endpoint was in-field progression at 2 years. The primary endpoint definition and a planned comparison with a historical control proportion of 0.5 are recorded, but the outcome data are not available.
The record lists enrollment as 1 and says the study was terminated early because of low accrual. Those details describe the scale and status of the study, not an effect estimate. There is no reported primary endpoint proportion, no reported comparison result, and no primary endpoint confidence interval. The registry therefore does not show whether in-field progression was more or less common than the historical benchmark.
The record also does not report results for the listed secondary outcomes of toxicity, local progression, progression-free survival, or overall survival. It does not provide analyses for these outcomes. The serious adverse event entries are sparse and lack comparative context, so they do not establish a treatment-related risk estimate.
In general, a study’s design can determine what kinds of conclusions its results could support. A single-group study does not provide a concurrent control comparison, and a historical reference may not be directly comparable to the enrolled participants. In this case, the more immediate limitation is that the registry reports no primary outcome data at all. Thus, it is not possible to assess the planned efficacy question using the posted results.
This does not mean the intervention succeeded or failed. It means the registry record does not contain the outcome evidence needed to answer the study’s primary question. The treatment description and endpoint plan explain what investigators intended to evaluate; they are not evidence of an observed clinical outcome. Any broader conclusion about benefit or harm would go beyond what the posted record supports.
13. Why This Trial Matters Statistically
This study is statistically important as an example of the distinction between a planned design and an interpretable result. The registry specifies a focused primary endpoint, in-field progression at 2 years, and identifies a proposed one-sample z-test against a historical control proportion. But because the study was terminated early for low accrual and the primary outcome data are unavailable, that plan cannot yield a reported estimate in the registry record.
The single-group design also clarifies the role of the historical benchmark. A historical proportion can serve as a reference for a planned analysis, but it is not a concurrently observed control group. In general, the interpretation of such a comparison depends on how well the historical reference represents the population and outcome assessment in the study. The registry record does not describe the source or comparability of the benchmark, so those questions remain unresolved.
The record lists enrollment as 1. This makes the difference between statistical planning and information actually collected especially visible. In general, sample-size calculations describe enrollment requirements under assumptions; they do not create evidence when outcome information is unavailable, and they are not observed power. Planning illustrations should not be mistaken for a completed efficacy analysis.
The registry also lists secondary outcomes and sparse adverse-event entries, but no analyses. That combination demonstrates why counts or outcome names alone are not substitutes for estimates, uncertainty measures, follow-up detail, and a comparison strategy. The posted record is useful for understanding what was intended and why the study did not produce a reported primary outcome, while leaving the central statistical question unanswered.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation is early termination for low accrual. The registry lists enrollment as 1 and states that primary outcome measure data are unavailable. Without the primary endpoint result, the planned evaluation of in-field progression at 2 years cannot be interpreted. The record also provides no reported results for the secondary outcomes.
The study was single-group and had no concurrent control arm. Its primary endpoint description proposed comparison with a historical control proportion of 0.5, but the registry record does not identify the source of that benchmark or describe its comparability to the study population and assessment procedures. A historical reference cannot be treated as a randomized or concurrently observed control.
Although the endpoint definition describes the treated volume and methods for confirming progression, the record does not report how the endpoint was assessed for the enrolled participant. It does not report whether the participant reached the 2-year assessment, follow-up completeness, or how incomplete outcome information would have been handled. These are not details that can be inferred from the endpoint definition.
The registry lists adverse-event entries for a very small group, including one death, and identifies acute kidney injury and hyperglycemia among serious-event terms. It does not provide enough detail in the recorded figures to establish attribution, event context, or a comparative safety profile. The record also does not report a multiplicity strategy, a detailed analysis plan beyond the named primary test, or an analysis population.
These limitations mean the registry record documents a study intention and limited enrollment, but not an evaluable primary outcome analysis. No unreported protocol details, sample-size justification, interim analyses, or missing-data methods can be assumed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients — NCT04398199.
- Registry record last updated 2022-10-05; status last verified 2022-09.
- Results first posted 2022-10-05.
- 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
NCT04398199 is a phase II, single-group study sponsored by Wake Forest University Health Sciences. It evaluated hypofractionated radiotherapy alone for people with locally advanced nonsmall cell lung cancer who declined or were ineligible for surgery or chemotherapy. Radiation planning was described as giving more dose to the more difficult-to-control tumor areas than to lower-risk areas.
The primary endpoint was presence or absence of in-field progression at 2 years, with a planned one-sample z-test against a historical control proportion of 0.5. The registry lists enrollment as 1 and reports that the study was terminated early because of low accrual. Primary outcome data are unavailable. Four secondary outcomes are listed, but their results are not reported, and the record lists 0 analyses.
The registry dates are 2020-10-16 for study start and 2020-11-20 for primary completion. The record documents the intended endpoint and design but does not provide an evaluable primary outcome estimate.