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 Intensity Modulated Radiation Therapy for Prostate Cancer (NCT00214422), a non-randomized early/phase 1 study. The primary outcome is Maximum Tolerated Dose (MTD) of External Beam Radiation to Pelvic Lymph Nodes of Interest in Patients Receiving Radiation Therapy for Prostate Cancer (After the First 10 Patients) In Arm 1, Arm 2, and Arm 3.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00214422 |
| Phase | EARLY/Phase 1 |
| Condition | Prostate Cancer |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with prostate cancer considered at high risk of lymph-node metastasis. Eligibility required a risk greater than 15%, as defined by the Partin tables. The registry reports an enrollment of 19, but does not provide enough information to characterize participants’ other clinical or demographic features. Details such as age distribution, disease stage, and prior treatment are not reported in the registry record.
Intervention
Participants received image-guided, targeted radiation therapy using intensity-modulated radiation therapy (IMRT). The registry describes three dose-level arms for treatment of the pelvic lymph nodes: 5040cGy, 5400cGy, and 5900cGy. The study’s stated objective was to assess the feasibility of treating at-risk lymph nodes with IMRT and to refine the technique through experience.
Comparator
This was not a randomized, like-for-like comparison. The registry identifies the study as non-randomized and single-group, while also listing three dose-level arms. It does not describe a separate untreated group, standard-treatment control group, or randomized allocation. The arm labels should therefore be read as recorded dose levels, not as evidence that patients were assigned comparably across groups.
Primary question
The primary outcome asked what maximum tolerated dose (MTD) of external-beam radiation to the pelvic lymph nodes could be identified. The registry defines the MTD as the dose level immediately below a level at which at least two patients in a cohort of either three or six experience a radiation-attributed dose-limiting toxicity. The record states that the MTD was not reached; it also says the original principal investigator left the National Institutes of Health and the reason the outcome was unmet could not be determined.
3. Trial Design
This completed study was registered as an early phase 1, non-randomized, single-group study of radiation treatment for prostate cancer. The registry reports enrollment of 19 and identifies the intervention as radiation. Its title and summary describe image-guided prostate and pelvic nodal irradiation with intensity-modulated radiation therapy (IMRT). The intended population had a high risk of nodal metastasis, defined in the eligibility description as greater than 15% according to the Partin tables.
Three dose-level arms are listed for pelvic lymph-node treatment: 5040cGy, 5400cGy, and 5900cGy. The registry does not describe randomized assignment to these dose levels. It also does not give arm-specific allocation procedures, explain how dose escalation or cohort progression was conducted, or state whether the listed arms correspond to sequential stages of enrollment. Those details are not reported in the registry record, so the arm labels alone cannot establish the process used to select a dose for any participant.
The study’s summary describes an initial plan to perform approximately five computed tomography simulations during treatment for the first ten patients, repeating the treatment plan and reassessing dose-volume information for target and normal tissues. The stated purpose was to learn about margins needed to account for organ motion and changes such as bowel gas and bladder fluid. The available description ends before all design details are given; any further protocol procedures are not reported in the registry record.
The primary outcome was MTD, assessed at completion of treatment, described as an average of 8.5 weeks. The study also listed six outcome measures in total, including toxicity outcomes. It is marked completed, with a start date of 2005-09-19 and primary completion date of 2014-05-27. The record does not provide a detailed account of recruitment, follow-up completion, or the analysis population.
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: 6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study.
Overall Study
| Stage | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes |
|---|---|---|---|
| STARTED | 12 | 3 | 4 |
| COMPLETED | 7 | 2 | 3 |
| NOT COMPLETED | 5 | 1 | 1 |
Reasons for not completing this period:
| Reason | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes |
|---|---|---|---|
| Physician Decision | 2 | 0 | 0 |
| Developed esophageal ca | 1 | 0 | 0 |
| Pt taken off study | 1 | 1 | 0 |
| Disease progression on study | 1 | 0 | 0 |
| Unable to make a radiation treatment | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: 6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study.
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 | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes | Total |
|---|---|---|---|---|---|
| Participants analysed | 12 | 3 | 4 | 19 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 | 2 | 0 | 9 |
| Age, Categorical: >=65 years | Participants | 5 | 1 | 4 | 10 |
| Age, Continuous | years | 64.14 (SD 7.41) | 59.37 (SD 20.36) | 67.68 (SD 2.78) | 64.13 (SD 9.35) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 12 | 3 | 4 | 19 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 12 | 3 | 4 | 19 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 2 | 0 | 4 |
| Race (NIH/OMB): White | Participants | 9 | 1 | 4 | 14 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 12 | 3 | 4 | 19 |
| Median Prostatic Specific Antigen (PSA) at Diagnosis | ng/ml | 16.65 (5.5 to 103) | 33.4 (5.7 to 42.9) | 8.95 (4.75 to 27.3) | 19.67 (4.75 to 103) |
| Median Gleason Score at Diagnosis | scores on a scale | 8 (7 to 9) | 7 (6 to 9) | 8 (7 to 8) | 7.6 (6 to 9) |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Tolerated Dose (MTD) of External Beam Radiation to Pelvic Lymph Nodes of Interest in Patients Receiving Radiation Therapy for Prostate Cancer (After the First 10 Patients) In Arm 1, Arm 2, and Arm 3, measured over Completion of Treatment, an average of 8.5 weeks.
| 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 maximum tolerated dose of external-beam radiation to the pelvic lymph nodes. The endpoint is intended to identify the highest dose level that can be delivered without crossing a prespecified toxicity boundary. In this registry, the MTD is defined as the dose level immediately below the level at which at least two patients in a cohort of either three or six experience a dose-limiting toxicity attributed to radiation therapy.
The registry defines an acute dose-limiting toxicity as Radiation Therapy Oncology Group (RTOG) grade 3 or greater acute gastrointestinal or genitourinary toxicity occurring within 3 months after completion of radiation. This definition makes the endpoint a treatment-tolerability measure based on both the severity and timing of adverse effects. Such an endpoint is used in early-phase dose evaluation because a dose level cannot be judged solely by the amount of radiation delivered; toxicity is part of the decision rule.
The registry states that the MTD was not reached. It further states that the original principal investigator left the National Institutes of Health and that the reason the outcome was not met could not be determined. It does not report a dose level meeting the endpoint definition, the number of dose-limiting toxicities used in the MTD assessment, or a completed MTD estimate. Therefore, the endpoint cannot be interpreted as evidence that any listed dose was established as tolerated under the study’s rule.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The principal result available for interpretation is that the registry records the MTD as not reached. This is not the same as reporting that no dose-limiting toxicities occurred, nor does it identify a tolerated dose. The record explicitly notes that the original principal investigator left the National Institutes of Health and that the reason the outcome was unmet could not be determined. Without the cohort-level toxicity information and the dose-assignment history, the MTD decision process cannot be reconstructed from the posted result.
The listed dose levels—5040cGy, 5400cGy, and 5900cGy—describe the treatment arms, but they do not by themselves show how those levels performed. The registry does not provide arm-specific primary-outcome estimates or a formal comparison of toxicity across the dose levels. Because allocation was non-randomized and the study is identified as single-group, differences between arms, if considered, would not automatically support a causal comparison. The record does not describe adjustment for differences between participants or other potential explanations for different observed outcomes.
The adverse-event record reports serious adverse events affecting 1 of 12 participants in the 5040cGy arm, 1 of 3 in the 5400cGy arm, and 0 of 4 in the 5900cGy arm. It reports non-serious adverse events affecting 12 of 12, 3 of 3, and 4 of 4 participants in those respective arms, and deaths of 0 in each arm. These figures are descriptive counts in small groups, not estimates of a causal dose effect. The registry also lists serious-event terms including infection with normal ANC or Grade 1 or 2 neutrophils::Liver at 33.3% and diarrhea at 8.3%. They should be read as posted event summaries, not as a substitute for the primary endpoint’s specific dose-limiting-toxicity assessment.
The registry lists 0 analyses. It does not report confidence intervals, a hypothesis test, an adjusted model, or an estimate of uncertainty for the primary endpoint. A confidence interval, as a general statistical concept, describes a range of values compatible with data under an analysis method and its assumptions; no such interval is reported for this primary result. The available record therefore supports a descriptive account of the study and its posted outcomes, but not a precise estimate of the MTD or a definitive comparison among dose levels.
General interpretation of small, non-randomized dose groups calls for caution: sparse events can make estimates unstable, and lack of random assignment can leave groups differing in ways relevant to outcomes. These are general considerations, not findings about specific imbalances in this study. Participant characteristics by arm and the reasons for any dose-level assignment are not reported in the registry record.
9. Statistical Methods Explained
The study’s main statistical task was to apply a toxicity-based dose rule. The registry defines the maximum tolerated dose (MTD) as the dose level immediately below a dose level at which at least two patients in a cohort of either three or six experience a dose-limiting toxicity attributed to radiation therapy. The acute dose-limiting toxicity definition is RTOG grade 3 or greater acute gastrointestinal or genitourinary toxicity within 3 months after radiation completion. This is a decision rule, not a test of whether treatment is superior to another treatment.
In general, dose-finding rules use observed toxicity to guide conclusions about dose tolerability. The interpretation depends on the dose levels studied, cohort sizes, definitions of toxicity, and the way participants move through dose levels. Here, the registry supplies the threshold definition and lists three dose-level arms, but does not report the sequence of allocation, the number of participants in each MTD cohort, or the dose-limiting toxicity count that would allow a reader to apply the rule independently. The registry’s conclusion that the MTD was not reached is therefore the posted primary result; the underlying dose-finding calculation is not available for verification.
The record identifies the design as non-randomized and single-group. In general, randomization helps balance measured and unmeasured characteristics between treatment groups, while a non-randomized design does not guarantee that balance. As a result, arm-level outcome differences cannot be attributed to dose alone without stronger design or analysis information. No adjustment strategy or covariate model is reported in the registry record. The three arm labels should be treated as descriptive categories, rather than as randomized comparison groups.
The endpoint’s toxicity criteria are categorical: toxicity is graded, and the acute DLT threshold is RTOG grade 3 or greater within a specified post-treatment interval. In general, categorical endpoints can be summarized with counts and proportions. Such summaries are easy to interpret but may be imprecise when group sizes are small or events are rare. The registry’s posted safety counts are descriptive; they do not provide a confidence interval or formal inferential comparison. A confidence interval is a general statistical tool for expressing uncertainty around an estimate, conditional on an analysis method and its assumptions. No primary-endpoint confidence interval is reported.
Over-dispersion is a general issue when count outcomes vary more than a simple statistical model expects. It can make model-based standard errors too small if ignored. This record does not report a count model or an over-dispersion assessment, so there is no basis for claiming that either was used or needed for the posted primary result. The primary outcome is described as a dose-threshold determination, not as a modeled count analysis.
Multiplicity refers, in general, to the increased chance of at least one false-positive finding when several hypotheses are tested. The study lists six outcome measures, including multiple toxicity outcomes, but the registry reports 0 analyses and no testing strategy. The number of outcomes alone does not establish how many formal hypotheses were tested. No multiplicity adjustment, hierarchy among secondary outcomes, or prespecified interpretation rule is reported in the registry record.
The study summary describes repeated CT simulations for the first ten patients, with treatment plans rerun and dose-volume data for target and normal tissues reassessed. In general, repeated measurements can characterize changes over time or under different anatomical conditions. The registry description frames this as a design objective related to treatment margins and organ motion. It does not report the resulting simulation measurements or a statistical model for repeated observations, so no quantitative conclusion about those measurements can be drawn.
Planning sample-size calculations are distinct from observed results. The planning illustration associated with the posted material is described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect expressed as a fraction of an observed effect; time-to-event illustrations use total events, while other illustrations use participants per arm. These assumptions are planning conventions, not evidence of the trial’s original design. The registry does not report a sample-size justification or state that these assumptions governed enrollment. Such calculations must not be interpreted as observed power or as proof that the study could detect a particular effect.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures, including the primary MTD outcome and secondary measures concerning late gastrointestinal or genitourinary toxicity, dose-limiting toxicity, adverse events, and acute or late high-grade toxicity. It lists 0 analyses. A prespecified statistical analysis plan, a hierarchy for interpreting outcomes, and a multiplicity adjustment are not reported in the registry record. The presence of several outcomes does not by itself show that formal hypothesis tests were conducted or that a particular adjustment was required; the record does not state how multiple outcomes were handled.
Missing-data procedures and analysis populations are also not reported in the registry record. There is no account of whether all enrolled participants received treatment, whether any participants were excluded from outcome summaries, how incomplete toxicity follow-up was handled, or whether analyses used an intention-to-treat or treated-participant population. The registry provides group-level denominators for adverse-event summaries, but does not explain how those denominators relate to all enrolled participants or to the primary endpoint analysis.
In general, missing outcomes can affect interpretation if participants with incomplete follow-up differ from those with complete information. Statistical approaches depend on why observations are missing and on the endpoint and design. No imputation method, sensitivity analysis, or missingness assumption is described. The registry also does not report interim analyses, stopping rules, or a detailed statistical plan. These absences limit independent assessment of how outcomes were selected, analyzed, and interpreted; they do not establish that any particular procedure was or was not used outside what the record states.
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 |
|---|---|---|---|
| Arm 1- 5040cGy to the Lymph Nodes | 1 | 12 | 8.3% |
| Arm 2 - 5400cGy to the Lymph Nodes | 1 | 3 | 33.3% |
| Arm 3 - 5900cGy to the Lymph Nodes | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm 1- 5040cGy to the Lymph Nodes | 0 of 12 |
| Arm 2 - 5400cGy to the Lymph Nodes | 0 of 3 |
| Arm 3 - 5900cGy to the Lymph Nodes | 0 of 4 |
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 |
|---|---|
| Arm 1- 5040cGy to the Lymph Nodes | 12 of 12 |
| Arm 2 - 5400cGy to the Lymph Nodes | 3 of 3 |
| Arm 3 - 5900cGy to the Lymph Nodes | 4 of 4 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes |
|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | 1 of 12 | 0 of 3 | 0 of 4 |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Liver | Infections and infestations | 0 of 12 | 1 of 3 | 0 of 4 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes |
|---|---|---|---|---|
| Fatigue (asthenia, lethargy, malaise) | General disorders | 10 of 12 | 2 of 3 | 2 of 4 |
| Hot flashes/flushes | Endocrine disorders | 9 of 12 | 3 of 3 | 2 of 4 |
| Weight gain | General disorders | 10 of 12 | 2 of 3 | 0 of 4 |
| Lymphopenia | Blood and lymphatic system disorders | 4 of 12 | 2 of 3 | 4 of 4 |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | 8 of 12 | 2 of 3 | 0 of 4 |
| Renal/Genitourinary - Other (Weak stream) | Renal and urinary disorders | 6 of 12 | 3 of 3 | 1 of 4 |
| Erectile dysfunction | Reproductive system and breast disorders | 8 of 12 | 0 of 3 | 1 of 4 |
| Pain::Abdomen NOS | Gastrointestinal disorders | 4 of 12 | 1 of 3 | 3 of 4 |
| Weight loss | General disorders | 6 of 12 | 1 of 3 | 1 of 4 |
| Incontinence, anal | Gastrointestinal disorders | 6 of 12 | 0 of 3 | 1 of 4 |
Serious events with the highest arm-level rate: infection with normal anc or grade 1 or 2 neutrophils::liver (33.3%), diarrhea (8.3%).
The registry reports serious adverse events affecting 1 of 12 participants in the 5040cGy arm, 1 of 3 in the 5400cGy arm, and 0 of 4 in the 5900cGy arm. Non-serious adverse events were reported for 12 of 12, 3 of 3, and 4 of 4 participants, respectively. Deaths are recorded as 0 in each arm. These are descriptive summaries, and the denominators differ across the listed dose groups.
The serious-event terms listed include infection with normal ANC or Grade 1 or 2 neutrophils::Liver at 33.3% and diarrhea at 8.3%. The record does not provide enough context to determine from these terms alone how each event maps to the primary DLT definition, whether an event was attributed to radiation, or its timing. The primary endpoint specifically concerns acute RTOG grade 3 or greater gastrointestinal or genitourinary toxicity within 3 months after radiation completion. A serious adverse event and a dose-limiting toxicity are not interchangeable categories.
Because the groups are small and were not randomized, the counts should not be read as evidence that one dose level is safer than another. They also do not describe the full clinical course of each participant. The registry does not report additional detail about event duration, recurrence, relatedness, or the method used to summarize repeated events.
12. What the Result Does, and Does Not, Mean
The posted record establishes that a completed early phase 1 study evaluated image-guided IMRT for prostate cancer, with pelvic lymph-node dose levels listed as 5040cGy, 5400cGy, and 5900cGy. Its primary question concerned the maximum tolerated dose under a defined toxicity rule. The registry states that the MTD was not reached and that the reason the outcome was unmet could not be determined after the original principal investigator left the National Institutes of Health.
This outcome does not mean that every dose level was free of dose-limiting toxicity, nor does it identify a dose as the MTD. The record does not report the cohort-level toxicity counts or dose progression information needed to evaluate the decision rule directly. Likewise, the adverse-event summaries do not establish a comparative safety ranking. The study was non-randomized, and the registry identifies its model as single-group; the listed arms are not described as randomized controls.
The record can support a limited descriptive reading of the reported safety counts and study design. It cannot provide a precise estimate of MTD, a reliable causal contrast between dose levels, or a conclusion about outcomes beyond those reported. It does not report a formal analysis result for the primary endpoint, confidence intervals, or hypothesis tests. Any discussion of uncertainty must therefore remain qualitative rather than implying a calculated degree of precision.
In general, feasibility and dose-tolerability studies can inform later research by documenting procedures, definitions, and observed events. That general role does not establish that a particular treatment is effective. The registry record describes feasibility as an objective, but the posted primary outcome does not establish that the MTD was determined, and the record does not report an efficacy endpoint result. Conclusions should be confined to the study’s stated design and the outcomes it actually posts.
13. Why This Trial Matters Statistically
This study is statistically notable because its main endpoint is a dose-finding decision rather than a conventional comparison of treatment against control. The MTD rule combines dose levels, cohort size, and a toxicity threshold. To reproduce or assess that decision, readers would need the observed dose-limiting toxicities and the pathway by which participants entered each dose cohort. The registry provides the rule and the final statement that the MTD was not reached, but not the information needed to reconstruct the decision.
The record also illustrates why design labels matter. It identifies the trial as non-randomized and single-group while listing three dose-level arms. Those labels discourage treating the arms as equivalent groups in a randomized comparison. Descriptive counts can communicate what was recorded, but they do not isolate a dose effect when assignment procedures and participant characteristics by arm are unavailable.
Finally, the registry distinguishes a stated objective from an interpretable outcome. The study sought to assess feasibility and refine treatment planning, including attention to organ motion and repeated imaging. Yet the primary MTD outcome is recorded as not reached, with the reason unresolved. That distinction is important when reading an early-phase record: a completed study does not necessarily yield a completed estimate for every endpoint. Transparent reporting of cohort progression, toxicity attribution, follow-up, and analysis methods would be needed for a fuller statistical assessment.
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 primary limitation is that the MTD was not reached, and the registry says the reason the outcome was unmet could not be determined. It does not report the dose-limiting toxicity counts by cohort, the sequence of dose levels, or enough detail to independently apply the MTD rule. This prevents reconstruction of the principal endpoint from the registry record.
The design is marked non-randomized and single-group, but three dose-level arms are listed. The record does not explain dose assignment, cohort transitions, or the role of each arm in the study. Consequently, the listed arms should not be treated as a controlled comparison. Participant characteristics by arm and potential differences in follow-up are not reported in the registry record.
Enrollment is reported as 19, while adverse-event denominators are reported separately for each arm. The registry does not explain whether these denominators represent all enrolled participants, all treated participants, or a particular safety population. It also does not give detailed information on missing outcomes, withdrawals, or the completeness of follow-up. The primary timeframe is completion of treatment, described as an average of 8.5 weeks, while acute DLT is defined within 3 months after treatment completion; details of endpoint ascertainment are not reported.
Further limitations include the absence of reported primary-endpoint estimates, confidence intervals, formal analysis results, and a statistical analysis plan. The registry lists 0 analyses. It does not provide a sample-size justification or explain how the listed outcome measures were prioritized. These gaps restrict precision, reproducibility, and interpretation of both the primary outcome and the safety summaries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Intensity Modulated Radiation Therapy for Prostate Cancer — NCT00214422.
- Registry record last updated 2019-07-19; status last verified 2019-07.
- Results first posted 2019-03-01.
- 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 describes a completed early phase 1, non-randomized, single-group study of image-guided IMRT for prostate cancer. The stated population was at high risk of lymph-node metastasis, and the study listed pelvic lymph-node radiation dose levels of 5040cGy, 5400cGy, and 5900cGy. Enrollment was 19.
The primary outcome was MTD, defined by a threshold for radiation-attributed acute toxicity. The registry states that the MTD was not reached and that the reason the outcome was unmet could not be determined after the original principal investigator left the National Institutes of Health. Safety summaries report serious and non-serious adverse events by listed arm, as well as 0 deaths in each arm. The record lists six outcome measures and 0 analyses. Details needed to reproduce the primary endpoint decision, assess missing data, or compare dose levels are not reported in the registry record.