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 Chemoradiation and Tetrathiomolybdate (TM) in Patients With Esophageal Carcinoma (NCT00176800), a na phase 2 study. The primary outcome is Median Recurrence Free Survival Time.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00176800 |
| Phase | Phase 2 |
| Condition | Esophageal Carcinoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 69 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Michigan Rogel Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
People with loco-regional esophageal carcinoma are the population named in the official trial title. The condition is listed as esophageal carcinoma, and the registry record lists an enrollment of 69. Further eligibility details, such as age range, disease-stage criteria, or required clinical characteristics, are not reported in the registry record.
Intervention
The study concerns preoperative chemoradiation and surgery followed by post-operative tetrathiomolybdate (TM). The arm description names paclitaxel, cisplatin, radiation, and surgical removal of the esophagus, but its final sentence is incomplete. The TM dose, schedule, and duration are not reported in the registry record.
Comparator
This is a single-group study, with allocation listed as not applicable and no masking. There is no concurrent control group described. The registry record therefore does not provide a like-for-like comparison between the intervention and another treatment or control condition.
Primary question
The primary outcome is median recurrence-free survival time, with a stated timeframe of 8 years. The endpoint description concerns time to recurrence after treatment. The registry record does not report the observed median, its 95% confidence interval, or a comparison with another group.
The study’s stated rationale is to examine whether adding TM to chemoradiation and surgery may affect outcomes for people with esophageal cancer. The brief summary describes TM as a drug that lowers copper levels and places the study within research on angiogenesis. That rationale is not itself evidence of an effect on recurrence or survival. The registry record lists median overall survival time and the percentage of patients requiring dose modification due to toxicity as secondary outcomes. It does not report numerical results for those outcomes.
3. Trial Design
The registry record describes a phase 2, single-group study sponsored by the University of Michigan Rogel Cancer Center. Enrollment is listed as 69, and the study status is completed. The recorded start is 2001-11 and the primary completion is 2006-02. These dates describe the registry record; they do not provide the timing of individual participants’ follow-up or the date when an outcome analysis was conducted.
The intervention sequence is preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate (TM). The arm description specifies paclitaxel by intravenous administration on Days 1, 8, 15, and 22; cisplatin on Days 1 and 22; and radiation twice daily on Days 1-5, 8-12, and 15-19. It also refers to surgical removal of the esophagus, but the description ends mid-sentence. The TM dosing schedule and full treatment details are not reported in the registry record.
There is no randomized allocation or masking. Because the study has a single group and no concurrent control described, the design can describe outcomes among participants receiving the regimen but cannot by itself establish how those outcomes compare with outcomes under another treatment. Differences from other populations or studies would not be controlled by random assignment in this record.
The primary endpoint is median recurrence-free survival time, with an 8-year timeframe. Median overall survival and dose modification due to toxicity are listed as secondary outcomes. The registry record does not describe the planned analysis methods, the analysis population, or how follow-up and censoring were handled. The number of participants who contributed to each outcome is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Chemoradiation and Tetrathiomolybdate (TM) |
|---|---|
| STARTED | 69 |
| COMPLETED | 69 |
| NOT COMPLETED | 0 |
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 | Chemoradiation and Tetrathiomolybdate (TM) |
|---|---|---|
| Participants analysed | 69 | |
| Age, Continuous | years | 60 (42 to 74) |
| Sex: Female, Male: Female | Participants | 67 |
| Sex: Female, Male: Male | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Median Recurrence Free Survival Time, measured over 8 years.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Recurrence-free survival is a time-to-event outcome: it concerns the time from a defined starting point until recurrence is observed. The registry record names median recurrence-free survival time as the primary endpoint and gives a timeframe of 8 years. It does not specify the exact time origin, the operational definition of recurrence, or how deaths without a recorded recurrence were treated.
A median is the point in the outcome distribution at which half of the observed time-to-event experience is on either side, subject to the method used to account for participants whose event time is not observed during follow-up. In general, a time-to-event median can summarize the timing of recurrence while allowing for incomplete follow-up when an appropriate survival method is used. The statistical method used for this endpoint is not reported in the registry record.
The registry record does not report the median value or its stated 95% confidence interval. Therefore, the posted record does not establish a numerical estimate of recurrence-free survival or its precision. The listed timeframe does not mean that every participant was followed for that length of time. Follow-up duration and the number of recurrence events are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical limitation is that the registry record names the primary endpoint but contains no posted outcome estimate for it. Median recurrence-free survival time is the stated primary outcome, and its timeframe is 8 years, but neither the median nor its 95% confidence interval is reported. Without those values, the magnitude and precision of the observed recurrence-free survival result cannot be described from this record.
The record also lists median overall survival time and dose modification due to toxicity as secondary outcomes. Numerical results for either are not reported in the registry record. The brief study rationale discusses possible effects on survival, but rationale and objectives are not outcome findings. No conclusion about recurrence or survival can be drawn from the descriptions of the treatment alone.
The single-group design is important for interpretation. It can report outcomes among people who received the treatment sequence, but there is no randomized concurrent comparator. The record explicitly lists allocation as not applicable and the model as single group. Consequently, the posted record does not provide a controlled estimate of how outcomes differ from those under another intervention. Any differences between participants in this study and people treated elsewhere could reflect differences in patient characteristics, care, follow-up, or other factors rather than the regimen itself.
The registry lists enrollment of 69, but does not state how many participants were included in each outcome analysis or how many experienced recurrence. It does not report a hazard ratio or other comparative effect estimate. A confidence interval, when reported, describes uncertainty around an estimate under the statistical method used; it does not remove the limitations of a single-group design. Here, the primary endpoint’s confidence interval is not reported in the registry record.
The record’s adverse-event data report 28 participants affected among 69 at risk for serious adverse events, and 67 among 69 at risk for other adverse events. These are safety counts, not measures of recurrence-free survival or evidence of a comparative treatment effect. The registry does not report whether events were judged related to treatment, their timing, or the analysis rules used. The serious event terms and percentages are descriptive listings; they do not establish that a particular event was caused by the regimen.
Overall, the posted information describes the study question, treatment sequence, design, and some adverse-event counts, but does not include the primary endpoint result or an inferential analysis. Statistical interpretation must therefore remain limited to what the record reports, rather than filling in missing outcome values or assuming a result from the study’s aims.
9. Statistical Methods Explained
The registry record identifies a time-to-event primary outcome and a single-group design, but does not report the statistical methods used to analyze the trial outcomes. The concepts below explain how such methods are generally interpreted; they should not be taken as a description of the methods actually used for this study unless the registry record states them.
What does a median time-to-event measure?
In general, a time-to-event outcome records the time until an event of interest occurs. For this study, the named event concerns recurrence, and the primary measure is the median recurrence-free survival time. A median gives a central summary of the event-time distribution. It does not describe every participant’s experience, nor does it indicate how many participants had recurrence at a particular time without further information.
Time-to-event data often include participants whose event has not been observed by the end of their available follow-up. Such observations are commonly described as censored: the exact event time is unknown, although some follow-up information is available. Appropriate survival-analysis methods can use this partial information. The registry record does not report whether censoring occurred, the method used to handle it, or the assumptions adopted for the analysis. It also does not define the precise time origin or recurrence criteria.
How should a confidence interval be read?
In general, a confidence interval communicates the statistical uncertainty around an estimate under the method used to calculate it. A narrower interval indicates greater precision in that estimate, while a wider interval indicates less precision. A confidence interval is not a guarantee that the true value lies within the reported interval, and it does not address systematic bias or the absence of a comparator. The primary endpoint is described as having a 95% confidence interval, but neither its interval nor its median estimate is reported in the registry record.
What can a single-group design estimate?
A single-group study can describe outcomes observed among participants who received the study regimen. Without a concurrent comparison group, it cannot directly separate the regimen’s contribution from other influences on those outcomes. Randomized comparisons are one way to balance measured and unmeasured factors on average between groups; this record does not describe randomization and lists allocation as not applicable. Comparisons with external groups would require additional design and analysis information, which is not reported in the registry record.
The model is listed as single group, and masking is listed as none. These design features do not tell the reader what statistical tests were used, whether endpoints were assessed by blinded reviewers, or how outcome data were managed. Those details are not reported in the registry record.
What do the planning illustrations mean?
In general, a sample-size calculation depends on assumptions about the effect to be detected, the statistical error rate, allocation, and the method of analysis. The planning assumptions described for this record use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is described as a stated fraction of the observed effect. For time-to-event illustrations, the calculation is expressed as a total number of events using the Schoenfeld approach; other illustrations are expressed as participants per arm.
These are planning illustrations, not evidence that this single-group study was designed or conducted as a two-arm comparison. They are explicitly not the trial’s own design. In general, an illustration based on an observed effect is conditional on that effect estimate and the assumptions used. It does not describe observed power, prove that the original study was adequately powered, or create a valid comparison where the design has no concurrent control group. No numerical planning results are reported in the registry record.
Why does over-dispersion matter in general?
For outcomes analyzed as counts, over-dispersion means that the observed variability is greater than a simple model expects. If ignored, standard errors and confidence intervals can be too small, making estimates appear more precise than they are. This is a general statistical consideration, not a reported feature of this trial. The registry record does not state that a count model was used or that over-dispersion was assessed.
What analysis details are absent?
The registry record reports no analyses and does not provide a statistical analysis plan. It does not report the model for recurrence-free survival, assumptions about censoring, covariate adjustment, handling of missing outcomes, or rules for defining evaluable participants. Hazard ratios are not reported. Although the general note for time-to-event results says that sponsor-reported hazard ratios are used, there is no hazard ratio result in this record to interpret. Any more specific account of the analysis would therefore be speculative.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one primary outcome, median recurrence-free survival time, and two secondary outcomes: median overall survival time and the percentage of patients requiring dose modification due to toxicity. Considering multiple outcomes can raise multiplicity concerns because testing several questions can increase the chance of at least one apparently notable result. In general, a prespecified hierarchy or adjustment can address some multiplicity concerns, but the approach used for this study is not reported in the registry record.
The record reports no analyses and does not state whether any interim analyses were planned or conducted. The statistical plan, analysis populations, and endpoint testing procedures are not reported in the registry record. It is therefore not possible to determine whether the listed endpoints were analyzed as prespecified, whether adjustments were made, or how the reported outcomes were selected.
Missing-data methods are also not reported. The registry record does not state how participants with incomplete follow-up, missing recurrence assessments, or unavailable secondary-outcome information were handled. It gives enrollment of 69, but does not state how many participants contributed to each analysis or whether all enrolled participants were included.
These absences limit assessment of possible bias and precision. They do not establish that data were missing or that analyses were not conducted; they mean that the relevant details are not reported in the registry record. No assumptions about missing outcomes, analysis populations, interim monitoring, or multiplicity procedures can be justified from the posted information.
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 |
|---|---|---|---|
| Chemoradiation and Tetrathiomolybdate (TM) | 28 | 69 | 40.6% |
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 |
|---|---|
| Chemoradiation and Tetrathiomolybdate (TM) | 67 of 69 |
Most frequent serious adverse event terms
| Event term | Organ system | Chemoradiation and Tetrathiomolybdate (TM) |
|---|---|---|
| Nausea | Gastrointestinal disorders | 4 of 69 |
| Diarrhea (no colostomy) | Gastrointestinal disorders | 3 of 69 |
| Anorexia | General disorders | 2 of 69 |
| Febrile neutropenia | Blood and lymphatic system disorders | 2 of 69 |
| Gastrointestinal-Other | Gastrointestinal disorders | 2 of 69 |
| Infection without neutropenia | Infections and infestations | 2 of 69 |
| Thrombotic microangiopathy | Vascular disorders | 2 of 69 |
| Bilirubin | Investigations | 1 of 69 |
| Cardiac-ischemia/infarction | Cardiac disorders | 1 of 69 |
| Cardiovascular/Arrhythmia-Other | Cardiac disorders | 1 of 69 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Chemoradiation and Tetrathiomolybdate (TM) |
|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | 54 of 69 |
| Anemia | Blood and lymphatic system disorders | 31 of 69 |
| Nausea | Gastrointestinal disorders | 30 of 69 |
| Vomiting | Gastrointestinal disorders | 22 of 69 |
| Neutopenia | Blood and lymphatic system disorders | 19 of 69 |
| Constipation | Gastrointestinal disorders | 19 of 69 |
| Thrombocytopenia | Blood and lymphatic system disorders | 12 of 69 |
| Diarrhea | Gastrointestinal disorders | 7 of 69 |
Serious events with the highest arm-level rate: nausea (5.8%), diarrhea (no colostomy) (4.3%), anorexia (2.9%), febrile neutropenia (2.9%), gastrointestinal-other (2.9%).
The registry record lists one treatment group with 69 participants at risk for serious adverse events and 28 affected. For other adverse events, 69 were at risk and 67 affected. The record does not report a death count. These counts describe the posted safety data; the time period used to collect events and the rules for including them are not reported in the registry record.
The listed serious adverse-event terms and percentages are nausea, 5.8%; diarrhea (no colostomy), 4.3%; anorexia, 2.9%; febrile neutropenia, 2.9%; gastrointestinal-other, 2.9%; and infection without neutropenia, 2.9%. They are registry-listed terms, not a complete account of every event or a comparison with another group. The record does not state whether events were considered related to treatment, or whether participants could contribute to more than one term. The percentages should not be added together to estimate the proportion of participants affected.
Because there is no concurrent control group, these safety figures do not show how the event experience compares with another treatment. They also do not, by themselves, establish that treatment caused any event.
12. What the Result Does, and Does Not, Mean
The posted record establishes that this was a completed phase 2, single-group study of chemoradiation, surgery, and post-operative tetrathiomolybdate for esophageal carcinoma. It identifies recurrence-free survival as the primary endpoint and lists overall survival and dose modification due to toxicity as secondary outcomes. It also provides counts of participants affected by serious and other adverse events and lists several serious-event terms with percentages.
The record does not report the primary endpoint result. In particular, it gives no median recurrence-free survival estimate or 95% confidence interval. It also does not report numerical results for the listed secondary outcomes, a hazard ratio, or a comparative estimate. The enrollment figure is not a substitute for outcome data, and the planned timeframe is not an observed result.
The design further limits what can be concluded. With a single group and no concurrent control, the record can describe the experience of participants who received the regimen but cannot isolate the treatment’s effect from other influences. The posted information therefore does not establish whether recurrence or survival differed from what would have occurred under another approach.
In general, a reported estimate and its uncertainty can help readers judge the size and precision of an outcome, while a suitable comparison helps interpret whether differences may be attributable to a treatment. Neither a primary endpoint estimate nor a controlled treatment comparison is reported in the registry record. The safety counts are descriptive and do not establish causation or comparative safety.
Thus, the record is informative about the study’s question, broad design, treatment sequence, and some safety reporting, but it does not provide the outcome results needed to quantify recurrence-free survival or assess a treatment effect. Conclusions beyond those reported details would require information not reported in the registry record.
13. Why This Trial Matters Statistically
This study raises several statistical issues that are important when reading clinical-trial records. First, the primary outcome is time to recurrence, so its interpretation depends on follow-up and on how incomplete event observation is handled. The registry record names median recurrence-free survival and an 8-year timeframe, but does not provide the estimate, confidence interval, follow-up detail, or event count. Without those elements, the endpoint’s observed magnitude and precision cannot be assessed.
Second, the design is single-group. This matters because an outcome observed after a treatment sequence is not, by itself, an estimate of the difference that treatment makes compared with another option. The absence of a concurrent randomized comparator means that the posted record cannot support a controlled treatment-effect comparison.
Third, the record distinguishes study objectives from results. Its rationale describes interest in TM and survival, while its endpoint list identifies recurrence-free survival as primary. Neither the rationale nor the endpoint designation supplies an observed outcome. The distinction helps prevent a scientific hypothesis from being mistaken for evidence that answers it.
Finally, the planning assumptions are described as illustrations rather than the trial’s design. Such calculations can illustrate how sample-size requirements depend on assumptions, but they do not establish observed power or validate a comparison absent from the study design. The registry record reports no analyses or statistical plan, so readers cannot evaluate the actual inferential procedures.
These points make the record statistically useful as a description of the question and design while also defining clear limits on what can be concluded from the posted results.
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 record leaves important design and treatment details unspecified. Although the arm description names paclitaxel, cisplatin, radiation, and esophageal surgery, its final sentence is incomplete. The tetrathiomolybdate dose, schedule, and duration are not reported in the registry record. Eligibility criteria and further participant characteristics are also not reported, limiting assessment of who the findings would represent even if outcome estimates were available.
For the primary outcome, the exact time origin, recurrence definition, follow-up distribution, event count, and censoring approach are not reported. The median and its 95% confidence interval are absent. The number of participants contributing to each endpoint and the handling of missing data are also not reported.
The single-group design has no concurrent control described, and there is no masking. This prevents a direct randomized comparison and leaves the reported safety counts without a control group for context. The registry record does not report whether adverse events were judged related to treatment or how long event collection continued.
The statistical plan and analysis methods are not reported. In particular, the record does not describe interim analyses, endpoint multiplicity procedures, analysis populations, adjustment for covariates, or sensitivity analyses. These gaps do not prove that particular procedures were absent; they mean the registry record does not report them. The primary endpoint result and numerical secondary-outcome results are likewise not reported, so the study’s outcome precision and substantive findings cannot be evaluated from the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Chemoradiation and Tetrathiomolybdate (TM) in Patients With Esophageal Carcinoma — NCT00176800.
- Registry record last updated 2016-08-22; status last verified 2016-07.
- Results first posted 2016-08-22.
- 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 identifies NCT00176800 as a completed phase 2 study sponsored by the University of Michigan Rogel Cancer Center. It lists enrollment of 69, a start date of 2001-11, and primary completion in 2006-02. The study concerns preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate for loco-regional esophageal carcinoma.
The design is single group, with allocation listed as not applicable and no masking. Median recurrence-free survival time, with an 8-year timeframe, is the primary outcome. Median overall survival time and dose modification due to toxicity are secondary outcomes. Numerical outcome results and the statistical analysis are not reported in the registry record.
Safety reporting lists 28 of 69 participants affected by serious adverse events and 67 of 69 affected by other adverse events. A controlled comparison is not available in the record, so the study information is descriptive rather than a randomized estimate of treatment differences.