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 Phase 2 Total Skin Electron Beam Therapy (TSEBT 12 Gy) in Stage IB-IIIA Mycosis Fungoides (NCT00985140), a registered phase not stated study. The primary outcome is Clinical Response Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00985140 |
| Phase | Phase not stated |
| Condition | Mycosis Fungoides, Lymphomas: Non-Hodgkin, Lymphomas: Non-Hodgkin Peripheral T-Cell |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 13 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Stanford University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with mycosis fungoides staged IB to IIIA. The registry record lists an enrollment of 13 and describes the primary endpoint population as all patients who completed treatment. It does not report how many participants completed treatment or how many were included in an endpoint analysis.
Intervention
The intervention was total skin electron beam therapy, described as TSEBT to a dose of 12 Gy. The record identifies it as radiation and describes prospective assignment to receive this treatment for mycosis fungoides.
Comparator
No comparator arm is listed. The registry record does not describe a randomized comparison or a control group, so the design does not provide a like-for-like treatment contrast.
Primary question
The primary endpoint was clinical response rate at 1 year. Response was defined using the modified severity weighted assessment tool: partial response required 50% improvement in mSWAT, while complete response meant complete disappearance of disease. The registry record does not report the response count or rate.
3. Trial Design
This was a Phase II study of total skin electron beam therapy to a dose of 12 Gy for mycosis fungoides staged IB to IIIA. The registry record identifies Stanford University as the sponsor and describes prospective assignment to receive the intervention. It lists an enrollment of 13 and the study status as terminated.
The record lists one treatment group, 12 Gy TSEBT, and no comparator arm. Allocation is not stated. Accordingly, the study record does not describe randomization or a controlled, like-for-like comparison. The design is best read as an investigation of response and safety within a treated group, not as an estimate of a treatment contrast against another intervention or usual care.
The primary endpoint was clinical response rate, with a timeframe of 1 year. The planned follow-up description says patients would be followed every 4 weeks until 24 weeks after treatment completion, then every 8 weeks for a total of 12 months or until disease progression, relapse, or initiation of a new anti-cancer therapy. This is a description of the intended follow-up schedule; the registry record does not report whether participants followed that schedule or how follow-up ended for each participant.
The endpoint population is described as all patients who completed treatment. The record does not give the number who completed treatment, the number with an evaluable response, or a primary endpoint analysis. The reason for termination, the timing of termination, and any consequences for recruitment or follow-up are not reported in the registry record. Thus, the listed enrollment and planned design should not be treated as proof that the planned endpoint assessment was completed.
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: Patients will undergo the following procedures during the screening period: Medical Hx, H\&P, Severity Weighted Assessment Tool (mSWAT) assessment, simulation/set-up for TSEBT, CT if needed, pruritus, hair, and nail assessment, standardized photos (global, nails, head: top, front, sides, back), and two 5 mm punch biopsies from an active MF lesion.
Overall Study
| Stage | 12 Gy TSEBT |
|---|---|
| STARTED | 15 |
| COMPLETED | 15 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: All patients who completed treatment.
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 | 12 Gy TSEBT |
|---|---|---|
| Participants analysed | 15 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 |
| Age, Categorical: >=65 years | Participants | 8 |
| Age, Continuous | years | 61.4 (SD 15.2) |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 10 |
| Region of Enrollment: United States | Participants | 15 |
6. Primary Endpoint
The registry lists the primary outcome as Clinical Response Rate, measured over 1 year.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was clinical response rate, measured at 1 year. It was intended to capture the proportion of the specified endpoint population—patients who completed treatment—meeting the study's response definition after TSEBT. The registry record defines partial response as 50% improvement in the modified severity weighted assessment tool (mSWAT) and complete response as complete disappearance of disease.
A response endpoint gives a categorical summary: each assessed participant is classified according to whether the prespecified response criteria are met. Such endpoints can make a clinical assessment easier to interpret than a continuous score alone, while the underlying mSWAT definition anchors the classification to a disease assessment. The response threshold and complete-response definition are stated in the record; further details on how assessments were conducted, who assessed them, or how ambiguous assessments were handled are not reported in the registry record.
The timeframe matters because response status can depend on when it is assessed. The record specifies 1 year and describes follow-up after treatment, with earlier visits and continued observation up to 12 months or until specified disease or treatment events. However, it does not report observed response counts, the response rate, or uncertainty around that rate. The endpoint definition therefore describes what was intended to be measured, not the outcome observed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study's clinical question and endpoint definition, but does not report the primary response result. It lists clinical response rate at 1 year as the primary endpoint and specifies how partial and complete response were defined. It does not provide the number of participants meeting either definition, a response rate, a confidence interval, or an analysis of the endpoint. Consequently, the treatment group's clinical response cannot be quantified from the registry record.
The record lists an enrollment of 13 and one treatment group receiving 12 Gy TSEBT. Enrollment is not the same as the endpoint analysis population. The stated population for the primary endpoint is all patients who completed treatment, but the number completing treatment and the number with an evaluable assessment are not reported in the registry record. Without those details, the relationship between enrollment and any possible response estimate is unknown.
The study has no listed comparator, and allocation is not stated. The data therefore do not offer a randomized or controlled comparison. Even if a response result were available, a response count within a single group would describe outcomes among assessed participants; it would not by itself separate the intervention's contribution from other explanations or establish a comparative effect. The record does not describe a control group or another design feature that would support such a contrast.
The status is terminated. The registry record does not state why the study was terminated, whether termination occurred before planned follow-up was complete, or how termination affected outcome collection. It is therefore not possible to infer the reason for the status or its effect on the availability of results.
Safety information is reported separately from the missing efficacy analysis. The record lists 1 serious adverse event-affected participant among 13 at risk in the 12 Gy TSEBT group, and it lists Syncope and Dermatology/Skin Other among the top serious terms, each at 7.7%. It also lists 13 affected participants among 13 at risk for other adverse events and 0 deaths. These counts describe the registry's safety entries; they do not supply the missing primary response result.
Any precision assessment of a response estimate requires both an estimate and its underlying analysis population. Since neither a response estimate nor an endpoint analysis is reported, no confidence interval or other measure of response precision can be interpreted from this record. The information supports a description of the plan and the reported safety counts, but not a numerical conclusion about clinical response.
9. Statistical Methods Explained
Clinical response rate is a binary endpoint: for the endpoint assessment, a participant either meets the response definition or does not. In this study, the definition distinguishes partial response, requiring 50% improvement in mSWAT, from complete response, defined as complete disappearance of disease. The registry record does not specify how these categories were combined in calculating the primary response rate, although it identifies clinical response rate as the endpoint. A detailed analysis rule is not reported in the registry record.
What does a response rate represent?
A response rate is a proportion within a defined analysis population. Its interpretation depends on the denominator as well as the number classified as responders. The planned endpoint population is all patients who completed treatment. The registry record lists an enrollment of 13, but does not state how many completed treatment, had an assessment at 1 year, or were included in an analysis. Enrollment alone cannot establish the denominator for a response rate. Because the response count and rate are also not reported, the endpoint cannot be recalculated or interpreted quantitatively.
How should precision be understood?
A confidence interval expresses uncertainty around an estimated quantity under a statistical model. For a binary response rate, it would communicate how imprecisely the observed proportion is estimated, given the number assessed and the response count. A narrow interval generally indicates greater statistical precision than a wide interval, but precision is not the same as protection from bias or proof of a causal effect. No response estimate or confidence interval is reported in the registry record, so there is no interval to assess. The small listed enrollment also makes it especially important not to confuse a planned cohort size with the actual endpoint denominator; the record does not report the latter.
What can a single-group study estimate?
With one listed treatment group and no comparator, an endpoint analysis would describe outcomes observed in that group. It would not directly estimate a difference between TSEBT and another treatment. In general, a comparator helps distinguish outcomes associated with an intervention from changes or influences that may occur regardless of intervention. Without a listed comparator, causal interpretation is limited even if a within-group response result is available. Here, the registry record does not report that result, so the supported interpretation is narrower still: it states what the study intended to measure, not what response was observed.
What do the planning assumptions mean?
The sample-size planning description states that its illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. These are planning assumptions, not a description of the treatment-group allocation in this study. The registry record lists one treatment group and no control arm. A planning illustration based on assumed allocation or a selected fraction of an effect does not mean the trial used that design, nor does it show that the trial had a particular probability of detecting an effect. Such calculations are not observed power and should not be read as trial results.
The sample-size description refers to an observed effect, but the registry record does not report the primary response result from which an effect could be inspected. No numerical planning outputs are stated in the record. Therefore, no sample-size illustration can be interpreted as a substitute for the missing outcome estimate, and no numerical conclusion about the adequacy of the study's size can be drawn from the listed assumptions alone.
Why can variability matter?
For outcomes measured as counts or rates, variability may exceed what a simple model assumes. In general, over-dispersion means the data vary more than expected under a model's assumed distribution. If it is present and ignored, standard errors and confidence intervals can be misleading. The registry record does not report an over-dispersion assessment or a statistical model for the primary endpoint. For a binary response endpoint, the central interpretive issues are the response definition, the number assessed, the observed response count, and the uncertainty around the resulting proportion; those outcome details are absent.
What analysis details are missing?
The record lists no analyses. It does not report an estimator, confidence-interval method, hypothesis test, covariate adjustment, handling of incomplete observations, or analysis population beyond the planned description of all patients who completed treatment. It also does not report whether response was assessed at a single visit or how data from follow-up visits contributed to the primary endpoint. These details affect reproducibility and interpretation. They should not be inferred from general conventions or from the stated endpoint name.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies clinical response rate as the primary endpoint and lists no analyses. It does not report secondary efficacy analyses or multiple hypothesis tests. No multiplicity adjustment, testing hierarchy, or prespecified approach to controlling the chance of false-positive findings is reported in the registry record. This absence should be read as missing reporting, not as evidence that no such plans existed.
The primary endpoint population is described as all patients who completed treatment. The record does not report the number who completed treatment, the number assessed at 1 year, or the number included in an analysis. It also does not state how missing or unevaluable response assessments were handled, whether participants who discontinued follow-up were counted as nonresponders, or whether any imputation was used. No such method should be assumed.
The follow-up description allows observation to end at disease progression, relapse, or initiation of a new anti-cancer therapy, as well as describing scheduled follow-up over 12 months. The record does not specify how these events affected the primary endpoint analysis or how incomplete follow-up was reflected in the result. It likewise does not describe an intention-to-treat population. The stated completer population is the only population definition given for the primary endpoint, and the extent to which it was used in practice is not reported in the registry record.
These omissions matter because exclusions and missing assessments can change both the denominator and the interpretation of a response rate. Without analysis-population counts and a missing-data rule, readers cannot determine whether the reported enrollment corresponds to the population underlying an endpoint estimate. In this record, no endpoint estimate is reported, so the effects of missing data cannot be evaluated.
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 |
|---|---|---|---|
| 12 Gy TSEBT | 1 | 13 | 7.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| 12 Gy TSEBT | 0 of 13 |
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 |
|---|---|
| 12 Gy TSEBT | 13 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | 12 Gy TSEBT |
|---|---|---|
| Syncope | Nervous system disorders | 1 of 13 |
| Dermatology/Skin Other | Skin and subcutaneous tissue disorders | 1 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 12 Gy TSEBT |
|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | 12 of 13 |
| Fatigue | General disorders | 7 of 13 |
| Nail Changes | Skin and subcutaneous tissue disorders | 6 of 13 |
| Pain (extremity) | Gastrointestinal disorders | 6 of 13 |
| Erythema | Skin and subcutaneous tissue disorders | 5 of 13 |
| Skin Infection | Skin and subcutaneous tissue disorders | 3 of 13 |
| desquamation | Skin and subcutaneous tissue disorders | 2 of 13 |
| Skin and subcutaneous tissue disorders-other | Skin and subcutaneous tissue disorders | 2 of 13 |
| Dry Skin | Skin and subcutaneous tissue disorders | 1 of 13 |
| edema, nos | General disorders | 1 of 13 |
Serious events with the highest arm-level rate: syncope (7.7%), dermatology/skin other (7.7%).
The registry record lists 1 serious adverse event-affected participant among 13 at risk in the 12 Gy TSEBT group. It names Syncope and Dermatology/Skin Other as the top serious adverse event terms, each reported as 7.7%. The record also lists 13 participants affected among 13 at risk for other adverse events and 0 deaths. These entries should be read as the safety counts and percentages recorded, not as a comparison with an untreated or alternative-treatment group.
A serious adverse event count is not the same as a count of every adverse event occurrence: the registry figures describe affected participants, while an individual participant may have more than one event. The record does not give event-level descriptions, timing, duration, severity grading beyond the serious classification, relatedness assessments, or the number of occurrences for each term. It also does not explain the relationship between the serious-event entries and the broader other-adverse-event counts.
With no comparator listed, the safety figures are descriptive. They do not establish whether events were caused by treatment or how the reported counts compare with another group. The absence of reported deaths in the listed group is a registry entry, not a broader safety conclusion. The reason for study termination and any effect on safety follow-up are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record supports a limited, descriptive account of the study. It identifies a Phase II investigation of 12 Gy TSEBT in patients with mycosis fungoides staged IB to IIIA, lists an enrollment of 13, and specifies clinical response rate at 1 year as the primary endpoint. It also gives a response definition based on mSWAT and provides safety counts for the listed treatment group.
It does not report the primary response count or rate, an uncertainty interval, or an analysis of the endpoint. Therefore, the record cannot establish how many participants responded or how precisely a response rate was estimated. The planned definition is not an observed result. The enrollment count does not resolve this gap because the endpoint population is described as patients who completed treatment, and the number completing treatment is not reported.
The record also does not provide a comparator. An outcome in a single treatment group, even if reported, would not by itself establish how outcomes differ from those under another intervention or without the intervention. No causal treatment contrast can be inferred from the listed design. The registry status is terminated, but no reason is given, so it would be unwarranted to attribute termination to safety, efficacy, recruitment, or any other cause.
The safety entries describe reported participant counts and event terms, not comparative risks or treatment attribution. They do not replace the missing response outcome. The posted record can therefore inform readers about the study question, intervention, intended follow-up, endpoint definition, and listed safety observations. It cannot support a quantitative conclusion about clinical response, comparative benefit, or the reason the study ended. These boundaries are important: registry descriptions of planned methods and reported counts should not be mistaken for a complete clinical trial analysis.
13. Why This Trial Matters Statistically
This trial is statistically instructive because the registry record contains a clear endpoint definition but no reported analysis of that endpoint. The distinction between a planned measurement and an observed result is fundamental. Clinical response rate is named as the primary outcome, and the response criteria are described, yet the record does not state a response count, rate, or confidence interval. A well-defined question does not, by itself, supply evidence about its answer.
The record also illustrates why population definitions matter. Enrollment is listed as 13, while the primary endpoint population is described as all patients who completed treatment. Without the number completing treatment and the number assessed, the denominator for any response estimate cannot be established. Clear accounting of enrollment, treatment completion, outcome assessment, and analysis inclusion is necessary for readers to understand what a reported proportion represents.
The single listed treatment group highlights the difference between describing outcomes and estimating comparative effects. A one-group result can summarize what was observed among participants, but it does not provide a controlled contrast. Statistical significance or a planning calculation cannot compensate for an absent comparator, and planning assumptions should not be mistaken for the study's actual design or observed power.
Finally, the terminated status and safety entries demonstrate the importance of careful registry interpretation. Termination does not explain why a study ended, and descriptive adverse-event counts do not establish cause or comparative safety. The record is useful for identifying what was intended and which safety observations were recorded, while also showing why missing outcome, follow-up, and analysis details constrain statistical conclusions.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation is that the registry record does not report the primary clinical response result. Although the endpoint and response criteria are specified, there is no response count, rate, confidence interval, or analysis. The central efficacy question therefore cannot be answered quantitatively from this record.
The listed enrollment is 13, but the endpoint population is described as patients who completed treatment. The number completing treatment, the number followed through the stated timeframe, and the number with evaluable assessments are not reported in the registry record. The reason for termination is also not stated, so it is unclear whether termination affected treatment completion, follow-up, or outcome reporting.
The design lists a single intervention group and no comparator. Allocation is not stated, and no control group is described. This prevents a direct comparative estimate and limits causal interpretation of any within-group outcome. The registry record also does not report the statistical analysis plan, analysis method, handling of missing response data, or multiplicity procedures. No reason for these reporting gaps should be inferred.
Safety information is limited to the listed participant counts, top serious-event terms, and deaths. Event-level details, timing, duration, treatment relatedness, and comparative safety data are not reported in the registry record. As a result, the safety entries should remain descriptive rather than being interpreted as evidence of cause or as a complete account of harms.
Finally, the planning description contains assumptions but does not report numerical planning outputs or the trial's own design justification. It cannot establish that the study was sized to detect a particular effect. These limitations arise from what the registry record reports and leave substantial uncertainty about both the outcome analysis and the circumstances of study completion.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase 2 Total Skin Electron Beam Therapy (TSEBT 12 Gy) in Stage IB-IIIA Mycosis Fungoides — NCT00985140.
- Registry record last updated 2017-06-02; status last verified 2017-05.
- Results first posted 2017-04-04.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a Phase II study of 12 Gy total skin electron beam therapy for mycosis fungoides staged IB to IIIA, sponsored by Stanford University. It lists an enrollment of 13, one treatment group, and a terminated status. The primary endpoint was clinical response rate at 1 year, with partial response defined as 50% improvement in mSWAT and complete response as complete disappearance of disease.
The endpoint population is described as patients who completed treatment, but the number completing treatment and the primary response result are not reported in the registry record. No analysis is listed, and no comparator arm is described. Safety entries include 1 serious adverse event-affected participant among 13 at risk, the serious-event terms Syncope and Dermatology/Skin Other at 7.7% each, 13 participants affected among 13 at risk for other adverse events, and 0 deaths. The reason for termination and the handling of missing endpoint data are not reported.