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 Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases (NCT02993146), a na phase 1 study. The primary outcome is Number of Participants Experiencing a Dose Limiting Toxicity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02993146 |
| Phase | Phase 1 |
| Condition | Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Brain |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Patients with cancer that has spread to the brain are the population described in the registry record. The listed conditions also include hematopoietic and lymphoid cell neoplasm and malignant solid neoplasm. The registry lists an enrollment of 11.
Intervention
The study combines oral ropidoxuridine with whole-brain radiotherapy. The treatment description specifies ropidoxuridine once daily on days 1-28 and radiotherapy beginning on day 8, delivered daily on no more than 5 days per week for a total of 15 fractions, unless disease progression or unacceptable toxicity occurs.
Comparator
There is no separate control group described. The registry identifies a single-group model, with allocation listed as NA and masking listed as none. Dose levels are included in the record, but they do not constitute a like-for-like control comparison.
Primary question
The primary endpoint counts participants experiencing a dose-limiting toxicity, defined in the registry as a protocol-defined, treatment-related adverse event. The outcome timeframe is up to week 8. The central question is how many participants experience such toxicity during the combination regimen; the primary endpoint result is not reported in the registry record.
The study is described as phase I and examines side effects and dose of ropidoxuridine when given with whole-brain radiotherapy. Its rationale is that ropidoxuridine may make cancer cells more sensitive to radiation, but the registry description is a study rationale, not evidence that this effect occurred. Secondary outcomes include disease response and intracranial status, pharmacokinetics, severe adverse events, and delayed neurological toxicity. Results for those outcomes are not reported in the registry record. Because there is no control group, the study is not designed as a direct comparison of the combination against radiotherapy alone or another treatment.
3. Trial Design
This is a phase I, single-group study of oral ropidoxuridine combined with whole-brain radiotherapy in patients with brain metastases. The registry lists allocation as NA and masking as none. It does not describe a randomized assignment or a concurrent control group. Although the safety record is divided into dose-level groups, those groups should not be interpreted as randomized comparison arms or as a controlled estimate of treatment effect.
The treatment description specifies ropidoxuridine by mouth once daily on days 1-28. Whole-brain radiotherapy begins on day 8 and is given daily on no more than 5 days per week for a total of 15 fractions, unless disease progression or unacceptable toxicity occurs. The registry also lists laboratory biomarker analysis, pharmacological study, and quality-of-life assessment as interventions or study activities. Further details of their timing and role are not reported in the registry record.
The registry lists enrollment as 11. The start date is 2017-05-08, and the primary completion date is 2022-08-19. The listed status is active, not recruiting. These dates and status describe the registry record; they do not establish that all outcomes have been reported. The sponsor is the National Cancer Institute.
The study includes dose levels 1A, 1B, 2A, and 2B in its adverse-event record. The registry does not report the assignment procedure, the rationale for these levels, or how decisions about dose escalation or selection were made. The protocol’s statistical plan and sample-size justification are not reported in the registry record. The design is therefore best understood from the available description as an early-phase, single-group safety and pharmacology study, not as a comparative efficacy trial.
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 | Dose Level 1A | Dose Level 1B | Dose Level 2A | Dose Level 2B |
|---|---|---|---|---|
| STARTED | 1 | 1 | 7 | 2 |
| COMPLETED | 1 | 1 | 6 | 1 |
| NOT COMPLETED | 0 | 0 | 1 | 1 |
Reasons for not completing this period:
| Reason | Dose Level 1A | Dose Level 1B | Dose Level 2A | Dose Level 2B |
|---|---|---|---|---|
| Withdrawal by Subject | 0 | 0 | 1 | 1 |
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 | Dose Level 1A | Dose Level 1B | Dose Level 2A | Dose Level 2B | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 1 | 1 | 7 | 2 | 11 | |
| Age, Continuous | years | 48 (48 to 48) | 50 (50 to 50) | 60 (55 to 73) | 58 (47 to 68) | 58 (47 to 73) |
| Sex: Female, Male: Female | Participants | 0 | 1 | 4 | 2 | 7 |
| Sex: Female, Male: Male | Participants | 1 | 0 | 3 | 0 | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 | 1 | 7 | 2 | 11 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 0 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 7 | 2 | 9 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 1 | 1 | 7 | 2 | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Experiencing a Dose Limiting Toxicity, measured over Up to week 8.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants experiencing a dose-limiting toxicity, with assessment described as extending up to week 8. The registry defines dose-limiting toxicities as protocol-defined, treatment-related adverse events. This endpoint is intended to capture adverse events judged to meet the study’s criteria for limiting treatment, rather than every event that might occur during the study. The specific criteria and adjudication process are not reported in the registry record.
In general, counting participants with a defined toxicity is useful in an early-phase study because it describes how often the outcome of interest occurred under the study regimen. When used in dose evaluation, this kind of endpoint can contribute to decisions about whether a dose merits further study. It does not, by itself, establish comparative safety, benefit, or the rate of toxicity in a broader population. Interpretation depends on the endpoint definition, the observation period, the number of participants assessed, and completeness of follow-up.
The record names the endpoint but does not report the observed count or an analysis of it. The adverse-event counts listed by dose level cannot be substituted for the primary endpoint: those records distinguish serious and other adverse events, while the primary endpoint is specifically dose-limiting toxicity as defined by the protocol.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome as the number of participants experiencing a dose-limiting toxicity up to week 8, but it does not report that outcome. Consequently, the primary endpoint cannot be described as observed, and no conclusion about its frequency can be drawn from the information in the record. The adverse-event entries are separate safety summaries and do not establish which events met the protocol definition of dose-limiting toxicity.
The adverse-event record is organized by dose level. It lists serious adverse events for 0 of 1 participants at dose level 1A, 0 of 1 at dose level 1B, 2 of 7 at dose level 2A, and 1 of 1 at dose level 2B. For other adverse events, the corresponding affected counts are 1 of 1, 1 of 1, 6 of 7, and 1 of 1. These are descriptive counts in small groups, not a controlled comparison. The groups differ in their listed sizes, and the registry does not report an analysis comparing them. The counts alone do not show that any difference between dose levels is reliable or caused by dose.
The record also lists deaths by dose level: 0, 1, 3, and 1, respectively. These entries should be read as registry death counts, not as proof that treatment caused a death or that a death was unrelated to treatment. The record does not report the circumstances, timing, causes, or attribution of these deaths. Those details are needed for a more complete interpretation.
Several secondary outcomes concern response, intracranial disease status, pharmacokinetics, adverse events, and delayed neurological toxicity. Their results are not reported in the registry record. The record lists zero analyses, and it does not provide effect estimates, uncertainty intervals, hypothesis tests, or analysis populations. Thus, the available information supports a description of the study design and of the posted adverse-event counts, but not estimates of treatment benefit or comparative safety.
Any apparent pattern across dose levels requires particular caution. The registry gives no randomized assignment, no concurrent comparator, and no reported adjustment for differences among participants. In a single-group early-phase study, observed counts can help characterize what was recorded during treatment, but they cannot separate treatment effects from disease, other care, chance variation, or differences in participant characteristics. The absence of a reported primary endpoint result is a central limit on interpretation, not evidence that the event did or did not occur.
9. Statistical Methods Explained
What does a participant count convey?
A count reports how many participants met a stated definition. For a safety endpoint, the definition and observation period matter: an event outside the specified period, or one that does not meet the protocol criteria, may not contribute to the endpoint count. The primary outcome is defined as participants with a protocol-defined, treatment-related dose-limiting toxicity up to week 8. The registry does not report the observed count, the criteria used to classify events, or the analysis population for this outcome. Without those details, the endpoint cannot be reconstructed from other safety summaries.
Counts are descriptive. A count does not by itself communicate how uncertain an estimate is, and a count from a small group can change substantially with a small change in observed events. A proportion can put a count in context by relating it to the number assessed, but a proportion should not be calculated unless the relevant denominator and analysis population are clear. The posted adverse-event entries include at-risk and affected counts by dose level, but do not identify a common comparison population or provide inferential analyses. Their role is descriptive.
What does a confidence interval add?
In general, a confidence interval expresses the precision of an estimate under a specified statistical procedure. A narrower interval indicates greater precision under that procedure; a wider interval indicates more uncertainty. It is not a guarantee that the true value lies within the interval, and it does not correct for limitations in study design, measurement, or participant selection. The registry record does not report confidence intervals for the primary endpoint or the adverse-event counts. Therefore, the precision of these outcomes cannot be assessed from interval estimates in the record.
For a single-group safety study, an interval around an event frequency would describe uncertainty about that group’s estimated frequency, subject to the definition and data quality. It would not provide a treatment-versus-control effect because no control group is described. Statistical precision and causal interpretation are different issues: a precise estimate in a single group would still not answer how outcomes would have differed under another treatment.
Why are dose-level counts not a dose comparison?
The registry reports counts within dose-level categories, but does not report randomized allocation or a formal comparison among those categories. A comparison of counts across groups needs attention to group sizes, follow-up, participant characteristics, and the process by which participants entered each dose level. If those features differ, the observed counts may reflect more than dose. The registry does not report the assignment process, a dose-comparison model, or adjusted estimates. No dose-response conclusion should be inferred solely from the displayed counts.
Over-dispersion is a general statistical concern when event counts vary more than a simple model expects. In such settings, a model that assumes too little variability can produce uncertainty estimates that are too optimistic. Whether over-dispersion is relevant depends on the outcome and analysis model. The registry record does not report a statistical model for the primary endpoint or event counts, so it is not possible to assess whether over-dispersion was considered.
What can a sample-size illustration show?
In general, a sample-size calculation describes the amount of information a planned study might need under stated assumptions about the target effect, significance level, allocation, and statistical method. It is a planning exercise, not an observed outcome. A planning illustration does not show that a completed study had a particular probability of finding a result, and it is not observed power. Its relevance depends on whether the assumptions match the intended design and the outcome being studied.
The record’s stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. For time-to-event outcomes, the stated output is the total number of events; for other outcomes, it is participants per arm. However, this trial is identified as a single-group study, and the registry does not report a primary endpoint result or statistical analyses from which an observed effect could be assessed. Sample-size calculations based on an observed effect therefore do not establish the design rationale or the achieved information in this trial. The trial’s own sample-size justification is not reported in the registry record.
Which analyses are reported?
The registry lists zero analyses. It does not report a statistical analysis plan, model specifications, hypothesis tests, estimates of effect, or uncertainty intervals. It also does not report whether any interim analyses occurred, what rules governed them, or whether analyses were adjusted for participant or treatment characteristics. Those elements should not be inferred from the phase designation, the endpoint description, or the adverse-event listings. The available record permits a design-level and descriptive reading, rather than a reconstruction of an inferential analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint and several secondary outcomes, including response categories, intracranial disease status, pharmacokinetics, severe adverse events, and delayed neurological toxicity. When a study evaluates multiple outcomes, there can be more opportunities for a result to appear notable by chance, particularly if many statistical tests are performed. In general, a multiplicity strategy may define which outcome is primary, adjust inference across tests, or treat secondary findings as descriptive. The appropriate approach depends on the study’s aims and prespecified statistical plan.
The statistical plan and any method for handling multiplicity are not reported in the registry record. The record also lists zero analyses, so it does not present a set of inferential results from which to assess whether multiplicity adjustments were applied. No claims about adjustment, hierarchy among secondary endpoints, or prespecification should be made on the basis of the outcome list alone.
Missing-data handling is likewise not reported in the registry record. The record does not describe how participants who discontinue treatment, miss assessments, or lack outcome measurements are handled, nor does it give missingness counts for the primary endpoint. This matters because missing outcomes can alter the apparent event frequency, especially when missingness is related to toxicity or disease status. The adverse-event entries do not resolve missingness for the primary endpoint.
The analysis populations are not reported in the registry record. It is therefore unclear which participants were considered evaluable for each outcome, how incomplete follow-up was handled, or whether the posted counts represent all enrolled participants or only those assessed. The registry lists enrollment as 11, but that listing alone does not define the denominator for each analysis. These gaps limit reproducibility and make it important to distinguish the registered endpoint and design from any unreported analysis choices.
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 |
|---|---|---|---|
| Dose Level 1A | 0 | 1 | 0.0% |
| Dose Level 1B | 0 | 1 | 0.0% |
| Dose Level 2A | 2 | 7 | 28.6% |
| Dose Level 2B | 1 | 1 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Dose Level 1A | 0 of 1 |
| Dose Level 1B | 1 of 1 |
| Dose Level 2A | 3 of 7 |
| Dose Level 2B | 1 of 1 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Dose Level 1A | 1 of 1 |
| Dose Level 1B | 1 of 1 |
| Dose Level 2A | 6 of 7 |
| Dose Level 2B | 1 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | Dose Level 1A | Dose Level 1B | Dose Level 2A | Dose Level 2B |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | 0 of 1 | 0 of 1 | 0 of 7 | 1 of 1 |
| Confusion | Psychiatric disorders | 0 of 1 | 0 of 1 | 1 of 7 | 0 of 1 |
| Diarrhea | Gastrointestinal disorders | 0 of 1 | 0 of 1 | 0 of 7 | 1 of 1 |
| Dizziness | Nervous system disorders | 0 of 1 | 0 of 1 | 0 of 7 | 1 of 1 |
| Dysphagia | Gastrointestinal disorders | 0 of 1 | 0 of 1 | 0 of 7 | 1 of 1 |
| Erythroderma | Skin and subcutaneous tissue disorders | 0 of 1 | 0 of 1 | 0 of 7 | 1 of 1 |
| Hyponatremia | Metabolism and nutrition disorders | 0 of 1 | 0 of 1 | 1 of 7 | 0 of 1 |
| Mucositis oral | Gastrointestinal disorders | 0 of 1 | 0 of 1 | 0 of 7 | 1 of 1 |
| Pancytopenia | Blood and lymphatic system disorders | 0 of 1 | 0 of 1 | 1 of 7 | 0 of 1 |
| Progressive disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 1 | 0 of 1 | 1 of 7 | 0 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dose Level 1A | Dose Level 1B | Dose Level 2A | Dose Level 2B |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 1 of 1 | 1 of 1 | 5 of 7 | 1 of 1 |
| Fatigue | General disorders | 1 of 1 | 0 of 1 | 6 of 7 | 0 of 1 |
| Nausea | Gastrointestinal disorders | 1 of 1 | 1 of 1 | 5 of 7 | 0 of 1 |
| Alopecia | Skin and subcutaneous tissue disorders | 1 of 1 | 0 of 1 | 4 of 7 | 1 of 1 |
| Anorexia | Metabolism and nutrition disorders | 1 of 1 | 0 of 1 | 4 of 7 | 0 of 1 |
| Dermatitis radiation | Injury, poisoning and procedural complications | 1 of 1 | 0 of 1 | 4 of 7 | 0 of 1 |
| Dry mouth | Gastrointestinal disorders | 1 of 1 | 0 of 1 | 3 of 7 | 0 of 1 |
| Dizziness | Nervous system disorders | 0 of 1 | 0 of 1 | 3 of 7 | 0 of 1 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 0 of 1 | 0 of 1 | 3 of 7 | 0 of 1 |
| Vomiting | Gastrointestinal disorders | 0 of 1 | 0 of 1 | 2 of 7 | 1 of 1 |
Serious events with the highest arm-level rate: acute kidney injury (100.0%), diarrhea (100.0%), dizziness (100.0%), dysphagia (100.0%), erythroderma (100.0%).
The safety record separates serious adverse events, other adverse events, and deaths by dose level. For serious adverse events, the listed affected counts are 0 of 1 at dose level 1A, 0 of 1 at dose level 1B, 2 of 7 at dose level 2A, and 1 of 1 at dose level 2B. For other adverse events, the counts are 1 of 1, 1 of 1, 6 of 7, and 1 of 1, respectively. These are descriptive entries, not adjusted estimates or a formal comparison between dose levels.
The registry also lists deaths by dose level as 0, 1, 3, and 1. The record does not give the circumstances, timing, cause, or treatment attribution for these deaths. A death count should not be read as evidence of causation without that context. The primary endpoint is specifically dose-limiting toxicity, not all serious adverse events, other adverse events, or deaths. The registry does not identify which listed events met the protocol definition of dose-limiting toxicity.
The record lists several serious adverse-event terms with 100.0%, including acute kidney injury, diarrhea, dizziness, dysphagia, erythroderma, and oral mucositis. The denominator underlying those percentages is not reported in the registry record, so their scope cannot be determined from the listing alone. They should not be interpreted as percentages of all enrolled participants.
12. What the Result Does, and Does Not, Mean
The results recorded for this study are not sufficient to determine the frequency of the primary endpoint: the number of participants with a dose-limiting toxicity up to week 8 is not reported in the registry record. The adverse-event entries provide descriptive counts by dose level, but they do not substitute for that endpoint. The registry also does not report analyses of response, intracranial disease status, pharmacokinetics, or delayed neurological toxicity.
These registry entries do not establish whether the combination provides benefit, whether it is more or less safe than another approach, or whether one dose level is preferable. The study has a single-group design and no described control group. Without a comparison, changes in disease status or events observed during treatment cannot be attributed to ropidoxuridine, radiotherapy, or their combination separately. Nor can the registry counts establish how participants would have fared under another treatment.
In general, early-phase studies can characterize treatment delivery, pharmacology, and safety signals that may inform further research. Such work can be important without answering comparative efficacy questions. The registry describes this study as phase I and lists pharmacological and biomarker activities, but does not provide their results or the dose-selection criteria. Therefore, the record supports statements about what was planned and which adverse-event counts were posted, not a conclusion about the regimen’s clinical effect.
The registry status is active, not recruiting, and the primary completion date is 2022-08-19. Those administrative details do not mean that all study outcomes are publicly reported. The listed enrollment is 11, while the sizes of the adverse-event groups vary. With these limited descriptive data and no reported primary endpoint analysis, uncertainty remains about outcome ascertainment, follow-up, event classification, and the interpretation of differences across dose levels. Any stronger conclusion would require results and methods not reported in the registry record.
13. Why This Trial Matters Statistically
Statistically, this trial illustrates the distinction between naming an endpoint and reporting an endpoint result. The registry defines dose-limiting toxicity and gives an assessment timeframe, but does not report the resulting count. Without that outcome, readers cannot estimate its observed frequency or examine its precision. The presence of other safety counts does not fill this gap because the definitions and purposes of those summaries differ.
The study also illustrates why design context matters when reading subgroup counts. Dose-level categories can be useful for describing what was recorded during early-phase treatment, but they are not automatically comparable groups. The record identifies a single-group model and does not report randomized assignment or an analysis comparing levels. A numerical contrast between such groups would not, by itself, establish a dose effect.
Another statistical lesson is that data availability and study completion are separate matters. The registry lists a primary completion date and an active, not recruiting status, yet does not report the primary outcome result or analyses. A registry entry can therefore convey important design and safety information while leaving important questions about outcomes, methods, and missing data unanswered.
These limitations do not make the study irrelevant. Phase I research can help characterize a regimen and its pharmacology and can motivate or inform later studies. But statistical interpretation must match the design and data actually recorded. Here, the most defensible reading is descriptive: identify the intended endpoint, recognize the posted adverse-event counts, and keep the absence of a reported primary analysis explicit. Claims about comparative benefit, causal safety effects, or a preferred dose would require information that the registry record does not report.
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 limitation for interpretation is that the primary endpoint result is not reported in the registry record. Although dose-limiting toxicity is defined and a timeframe is given, the observed count, the number assessed, and the event-classification details are absent. The adverse-event summaries cannot be used as replacements because they do not indicate which events met the primary endpoint definition.
The study is single-group and has no described comparator. This prevents a controlled estimate of how outcomes differ from another treatment or from no ropidoxuridine. The record also does not describe how participants were assigned to dose levels or how dose decisions were made. The posted counts should not be treated as evidence of a causal dose-response relationship.
The adverse-event group sizes are limited, and the record does not give uncertainty intervals or formal comparisons. Small descriptive counts can be imprecise, while the lack of reported follow-up and analysis-population details makes it difficult to judge whether the listed denominators apply consistently across outcomes. The registry does not report the context or attribution of deaths, nor the denominator for the listed serious adverse-event term percentages.
Further limitations are that the statistical analysis plan, sample-size justification, multiplicity strategy, missing-data approach, and analysis populations are not reported in the registry record. The registry lists zero analyses, and results for secondary outcomes are not reported. Consequently, the record does not allow independent assessment of model assumptions, endpoint completeness, or the precision of estimates. These omissions constrain interpretation to the design description and posted descriptive safety entries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases — NCT02993146.
- Registry record last updated 2026-10-21; status last verified 2026-09.
- Results first posted 2024-02-20.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
The registry identifies NCT02993146 as a phase I, single-group study of oral ropidoxuridine with whole-brain radiotherapy in patients with brain metastases. The record lists enrollment as 11, allocation as NA, masking as none, and status as active, not recruiting. The study start date is 2017-05-08, and the primary completion date is 2022-08-19.
The primary endpoint is the number of participants experiencing a protocol-defined, treatment-related dose-limiting toxicity up to week 8. Its result is not reported in the registry record. The registry lists adverse-event counts by dose level and several secondary outcomes, but reports zero analyses. Statistical methods, missing-data handling, and analysis populations are not reported. The posted information supports descriptive interpretation only and does not establish a comparative treatment effect.