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 Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer (NCT00551759), a na phase 2 study. The primary outcome is Proportion of Patients With Pathologic Complete Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00551759 |
| Phase | Phase 2 |
| Condition | Esophageal Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eastern Cooperative Oncology Group |
| Results posted | Yes |
2. Clinical Question
Population
Patients with operable adenocarcinoma of the esophagus were the population described in the official title. The registry lists esophageal cancer as a condition and identifies the primary endpoint population as eligible and treated patients. The broader brief description also refers to gastroesophageal junction cancer, so the exact relationship between those descriptions is not clarified in the record.
Intervention
The planned approach combined chemotherapy and radiation with cetuximab before surgery. The registry names oxaliplatin, infusional 5-fluorouracil, cetuximab, radiotherapy, surgery, and postoperative docetaxel and cetuximab. The arm description gives dosing days for the preoperative drugs and radiotherapy, but does not describe the postoperative schedule.
Comparator
This was a single-group study with no randomized allocation and no like-for-like control group. The registry therefore does not pose a treatment-versus-control comparison. Its design can describe outcomes among participants treated under the study approach, but cannot by itself separate treatment effects from other explanations for those outcomes.
Primary question
The primary endpoint asks what proportion of eligible and treated patients had a pathologic complete response at surgery. The resected esophageal and nodal tissue was examined by a pathologist; a complete response was defined as no histopathologic evidence of tumor in that specimen. The registry record does not report the observed proportion or its 90% confidence interval.
The study was intended to assess response and toxicity in patients receiving a sequence of preoperative chemoradiotherapy and cetuximab, surgery, and planned postoperative docetaxel and cetuximab. The clinical question is therefore descriptive within a treated group: what pathologic response was observed, and what adverse events were recorded? The absence of a concurrent control group means the study does not establish how those outcomes compare with another treatment strategy or with outcomes in similar patients who did not receive this regimen.
The registry’s brief description includes both esophageal and gastroesophageal junction cancer, while the official title specifies operable adenocarcinoma of the esophagus. The record does not provide further detail to resolve that difference. It also does not report participant characteristics that would help readers assess how closely the enrolled group represents a broader clinical population.
3. Trial Design
This is a Phase II, single-group interventional study. The registry lists allocation as not applicable and masking as none. No randomized comparator is recorded. The planned approach combined neoadjuvant chemoradiotherapy and cetuximab with surgery, followed by postoperative docetaxel and cetuximab. The registry status is terminated; the reason for termination is not reported in the registry record.
The arm description specifies oxaliplatin by intravenous infusion on days 1, 15, and 29; cetuximab on days 1, 8, 15, 22, and 29; and 5-fluorouracil by continuous intravenous infusion on days 1-35. Radiotherapy was scheduled on days 1-5, 8-12, 15-19, 22-26, and 29-33. The overall study description says surgery and postoperative docetaxel and cetuximab followed neoadjuvant treatment, but the detailed postoperative regimen and the criteria or timing for proceeding to surgery are not reported in the registry record.
Enrollment is listed as 22. The primary endpoint population is described as eligible and treated patients, which may not necessarily be the same as all enrolled participants. The registry does not report a participant flow accounting for eligibility, treatment received, surgery, or inclusion in the endpoint analysis. It also does not give a reason for termination or explain whether termination affected enrollment, follow-up, or reporting.
Because the study is uncontrolled, its design is suited to recording outcomes in the treated group, not to estimating a comparative treatment effect. Any comparison with an external or historical group would require additional assumptions and compatible data; no such comparison is specified in the registry record. The registry lists one outcome measure and no analysis entries. A more detailed statistical analysis plan, including any planned adjustment, interim monitoring, or handling of protocol deviations, 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 | Neoadjuvant Therapy, Surgery, Adjuvant Therapy |
|---|---|
| STARTED | 22 |
| Eligible and Began Treatment | 21 |
| Underwent Surgery | 17 |
| Received Adjuvant Therapy | 12 |
| COMPLETED | 9 |
| NOT COMPLETED | 13 |
Reasons for not completing this period:
| Reason | Neoadjuvant Therapy, Surgery, Adjuvant Therapy |
|---|---|
| Adverse Event | 7 |
| Death | 5 |
| Ineligible | 1 |
Analysis population for the primary outcome, as defined in the registry: Eligible and treated patients
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.
Population: Eligible and treated patients
| Characteristic | Unit | Neoadjuvant Therapy, Surgery, Adjuvant Therapy |
|---|---|---|
| Participants analysed | 21 | |
| Age, Continuous | years | 62 (45 to 79) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Patients With Pathologic Complete Response, measured over At time of surgery (which occurred 63 to 91 days after study entry).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 90% Confidence Interval |
| Unit | Proportion of patients |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the proportion of eligible and treated patients with a pathologic complete response at surgery. The registry defines this response as the absence of any histopathologic evidence of tumor in the resected esophageal and nodal tissue specimen. It is assessed after neoadjuvant treatment, when the surgical specimen can be examined directly by a pathologist. The stated timeframe is at surgery, which occurred 63 to 91 days after study entry.
This endpoint captures whether tumor was detected in the specified tissue at the time of resection. It is a binary classification at the participant level: the specimen either meets the registry definition of pathologic complete response or it does not. The proportion expresses how common that classification was among the endpoint population. It does not describe the degree of tumor shrinkage in participants whose specimens still contain tumor, nor does it by itself describe later recurrence, survival, symptoms, or quality of life.
Pathologic response is used in this setting because it is based on tissue obtained during surgery after preoperative therapy, rather than on imaging alone. It provides a direct assessment of the resected specimen under the stated definition. Interpretation still depends on consistent pathology assessment, the population included in the denominator, and complete reporting of response data. Those details beyond the endpoint definition and population are not reported in the registry record.
The registry specifies a 90% confidence interval for this endpoint, but does not report the observed response count, proportion, or interval. As a result, the degree of uncertainty around the response estimate cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies pathologic complete response as the primary endpoint, but no observed response count, proportion, or 90% confidence interval is reported in the registry record. Consequently, the primary result cannot be described from this record, and its precision cannot be evaluated. The registry status is terminated, but the reason for termination and its implications for data collection or analysis are not reported. Neither the stated endpoint nor the trial status alone establishes what response was observed.
The study’s single-group design is important to interpretation. An observed response proportion, if reported, would describe the eligible and treated participants assessed under the study definition. Without a concurrent control group, it would not show how the same participants would have fared under another regimen or without the study treatment. Differences from outcomes in other studies could reflect differences in patient characteristics, eligibility, treatment delivery, endpoint assessment, or follow-up, as well as treatment itself. The registry record provides no comparative estimate.
The stated primary population is eligible and treated patients, whereas enrollment is recorded separately. The record does not give the number of participants included in the endpoint analysis, nor explain how participants without an evaluable surgical specimen were handled. This matters because the denominator affects the estimated proportion, and exclusions or missing endpoint data can change how representative the estimate is of everyone who entered the study. The registry does not report participant flow or a missing-data method.
The endpoint is assessed in tissue at surgery, with surgery described as occurring 63 to 91 days after study entry. This anchors the response assessment to a clinical procedure, but does not indicate the durability of response or subsequent outcomes. The registry does not report recurrence, survival, or longer-term follow-up results as outcomes in this record.
Serious adverse events were recorded in the treatment group: 19 of 22 participants were reported as affected, with 22 at risk. The record also reports other adverse events for 22 of 22 participants at risk. The listed serious-event terms and their percentages describe event reporting in this group, not a comparison with another group. The record does not provide event-level timing, duration, severity grading beyond the serious classification, or attribution details in the registry record for this analysis.
Overall, the registry record identifies the study question, treatment sequence, endpoint definition, and selected safety counts, but lacks the primary response estimate and important analysis details. Conclusions about the magnitude and precision of pathologic response, comparative effects, and longer-term outcomes are therefore not supported by the reported information.
9. Statistical Methods Explained
The primary endpoint is a proportion. Each participant in the endpoint population is classified according to whether the surgical specimen meets the registry definition of pathologic complete response. The proportion is the count meeting that definition divided by the number assessed in the endpoint population. The registry record names eligible and treated patients as the population, but does not report the response count, denominator used in the analysis, or resulting proportion.
What does the confidence interval describe?
A confidence interval expresses statistical uncertainty around an estimate. For a proportion, its width depends in part on how many observations contribute and how the responses are distributed. A narrower interval indicates greater precision under the method’s assumptions; a wider interval indicates less precision. An interval does not describe the range of individual patient outcomes, and it does not guarantee that the true value lies within its endpoints. The registry specifies a 90% confidence interval, but neither the interval nor the estimate it would surround is reported in the registry record. Its precision therefore cannot be assessed.
What does a single-group design allow?
A single-group study can report the frequency of an outcome among participants receiving the study approach. It cannot, without a valid comparison, estimate the difference that would have occurred relative to another treatment. A change observed after treatment also does not by itself establish that treatment caused the change. In an uncontrolled study, patient selection, disease characteristics, assessment procedures, and other factors may contribute to observed outcomes. This is a general limitation of the design, not a finding about any particular participant in this study.
The registry lists allocation as not applicable, masking as none, and the model as single-group. Those descriptions align with a study intended to assess response and toxicity in a treated group, rather than compare randomized groups. The registry does not report a statistical plan describing how outcomes were to be estimated or whether any covariates were considered.
Why does the analysis population matter?
The stated endpoint population is eligible and treated patients. That definition identifies the intended population for the primary measure, but it does not tell the reader exactly how many participants were included or how eligibility and treatment receipt were determined for the analysis. Enrollment is listed separately. A transparent endpoint report would identify the numerator and denominator, explain any exclusions, and describe how participants without an evaluable specimen were handled. Those details are not reported in the registry record.
Missing endpoint data can affect interpretation when the likelihood of being assessed is related to prognosis, treatment tolerance, or other participant characteristics. Complete-case estimates describe those with observed results; they may not represent all enrolled participants if assessment is incomplete in a systematic way. Statistical methods can make assumptions about missing observations, but those assumptions cannot be evaluated without knowing the extent and pattern of missingness. The registry record does not report endpoint missingness or a method for handling it.
How should the event counts be understood?
The registry records serious adverse events and other adverse events separately. The serious-event figures report how many participants were affected and at risk; the other-event figures do the same for that category. These are participant-level counts as represented in the record, not necessarily counts of individual event episodes. One participant may experience multiple events, so participant counts should not be treated as event totals. The record’s top serious-event terms are accompanied by percentages, but a detailed event listing and event-level denominators are not included in the registry record.
What is over-dispersion, and does it apply?
Over-dispersion is a general concern when count data vary more than an assumed statistical model allows. For example, event counts may differ substantially among participants, or events may cluster within participants. Treating observations as more independent or less variable than they are can make uncertainty estimates too small. Whether over-dispersion is relevant depends on the outcome and model. The primary endpoint is described as a proportion, while the registry’s safety figures are participant counts and selected percentages. No modeling approach for either endpoint is reported, so no claim can be made about whether over-dispersion was assessed.
What do planning illustrations mean?
A sample-size calculation is a planning exercise that estimates how much information a future study might need under chosen assumptions. The registry’s stated illustration assumptions describe a two-sided significance level of 0.05, equal allocation between two hypothetical arms, a normal approximation, and an effect defined as a fraction of the observed effect. These assumptions describe an illustration, not the actual single-group design. No numerical planning results are included in the registry record for this analysis. Such calculations are not observed power, do not show that the study was adequately powered, and do not replace the missing response estimate or confidence interval.
The record does not report the trial’s own sample-size justification, any interim analyses, or a detailed statistical analysis plan. It is therefore not possible to establish from the registry record how the study’s original design decisions were made or whether the reported endpoint analysis followed a prespecified method.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Neoadjuvant Therapy, Surgery, Adjuvant Therapy | 21 | 0 | 0.0% | 0.0% to 16.1% | -0.0% to 15.5% | 0.1% to 15.4% |
R code and output
arm <- c("Neoadjuvant Therapy, Surgery, Adjuvant Therapy")
n <- c(21)
events <- c(0)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Neoadjuvant Therapy, Surgery, Adjuvant Therapy 21 0 0.0 0.0 16.1 -0.0 15.5 0.1 15.411. Multiplicity, Missing Data and Analysis Populations
The registry identifies pathologic complete response as the primary endpoint and lists one outcome measure, but does not report a detailed analysis plan. It does not state whether additional hypotheses were tested, whether secondary outcomes were prespecified, or how multiplicity was to be handled. Multiplicity is a general concern when several outcomes or comparisons are tested: the chance of at least one apparently notable result can rise as the number of tests increases. Without a stated testing strategy or analysis results, the consequences of multiplicity cannot be assessed for this study.
The registry reports no analysis entries. It also does not provide the endpoint numerator and denominator, participant flow, or the number of eligible and treated patients with an evaluable surgical specimen. Those omissions prevent assessment of whether the analysis population differed from the enrolled population or whether missing assessments could affect the response estimate. The handling of protocol deviations, withdrawals, and missing endpoint observations is not reported in the registry record.
The endpoint population is described as eligible and treated patients. That is not enough to determine whether all enrolled participants were included, how eligibility was established, or how participants who did not proceed to surgery were treated analytically. No imputation method, sensitivity analysis, or missing-data assumption is reported. The absence of these details does not establish that missing data occurred; it means the registry record does not describe whether they occurred or how they were addressed.
The record does not report interim analyses, stopping rules, or a statistical plan for deciding when the study should end. The status is terminated, but the reason for termination is not reported in the registry record. Thus, the relationship between termination, enrollment, follow-up, and analysis cannot be determined from the available registry information.
12. 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 |
|---|---|---|---|
| Neoadjuvant Therapy, Surgery, Adjuvant Therapy | 19 | 22 | 86.4% |
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 |
|---|---|
| Neoadjuvant Therapy, Surgery, Adjuvant Therapy | 22 of 22 |
Most frequent serious adverse event terms
| Event term | Organ system | Neoadjuvant Therapy, Surgery, Adjuvant Therapy |
|---|---|---|
| Dehydration | Metabolism and nutrition disorders | 8 of 22 |
| Lymphopenia | Investigations | 5 of 22 |
| Fatigue | General disorders | 5 of 22 |
| Anorexia | Metabolism and nutrition disorders | 5 of 22 |
| Esophagitis | Gastrointestinal disorders | 5 of 22 |
| Nausea | Gastrointestinal disorders | 5 of 22 |
| Anemia | Blood and lymphatic system disorders | 4 of 22 |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | 4 of 22 |
| Hypocalcemia | Metabolism and nutrition disorders | 4 of 22 |
| (ARDS) | Respiratory, thoracic and mediastinal disorders | 4 of 22 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Neoadjuvant Therapy, Surgery, Adjuvant Therapy |
|---|---|---|
| Fatigue | General disorders | 18 of 22 |
| Anemia | Blood and lymphatic system disorders | 16 of 22 |
| Nausea | Gastrointestinal disorders | 15 of 22 |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | 11 of 22 |
| Vomiting | Gastrointestinal disorders | 11 of 22 |
| Neuropathy-sensory | Nervous system disorders | 11 of 22 |
| Weight loss | Investigations | 10 of 22 |
| Anorexia | Metabolism and nutrition disorders | 10 of 22 |
| Muco/stomatitis (symptom) esophagus | Gastrointestinal disorders | 10 of 22 |
| Hypocalcemia | Metabolism and nutrition disorders | 10 of 22 |
Serious events with the highest arm-level rate: dehydration (36.4%), lymphopenia (22.7%), fatigue (22.7%), anorexia (22.7%), esophagitis (22.7%).
The registry reports serious adverse event figures for the neoadjuvant therapy, surgery, and adjuvant therapy group: 19 of 22 participants were affected, with 22 at risk. For other adverse events, 22 of 22 participants were affected and at risk. These figures describe participants reported as having at least one event in each category, as represented by the registry; they are not counts of event episodes. A participant may have experienced more than one type of event or more than one episode.
The most frequently listed serious-event terms are dehydration at 36.4%, and lymphopenia, fatigue, anorexia, esophagitis, and nausea, each at 22.7%. These are registry percentages for the named terms. The record does not provide event-level details such as onset, duration, recurrence, or attribution in the registry record for this analysis. The figures do not establish whether an event was caused by a particular treatment component.
These safety data come from a single treatment group, so they do not provide a comparative estimate of excess risk. The registry does not report a control group, and the participant counts do not describe how risks would differ under another approach. Serious adverse event reporting and other adverse event reporting are separate categories; the figures should not be combined or interpreted as a total number of events. The registry record also does not report deaths in this group.
13. What the Result Does, and Does Not, Mean
The registry record documents a Phase II, single-group study of neoadjuvant chemoradiotherapy with cetuximab, followed by surgery and planned postoperative docetaxel and cetuximab. It defines pathologic complete response using examination of the resected esophageal and nodal tissue. This establishes what the primary outcome was intended to measure and when it was assessed. However, the record does not report the observed response proportion, response count, or 90% confidence interval. The primary result and its precision therefore cannot be interpreted from the registry record.
The study design also limits what any response proportion could establish. An outcome observed within a treated group is descriptive; without a concurrent comparator, it does not estimate how outcomes would differ under another treatment. It cannot isolate a treatment effect from participant selection, disease features, supportive care, or other influences. The registry does not report a randomized comparison, and the study should not be read as a like-for-like comparison of treatment options.
Pathologic complete response is a tissue-based assessment at surgery. It does not, by itself, establish longer-term disease control, survival, quality of life, or the experience of participants whose specimens do not meet the complete-response definition. Those outcomes are not reported in the record used for this analysis. The stated surgery timeframe is 63 to 91 days after study entry, but the record does not provide longer-term follow-up results.
The safety figures indicate that adverse events were recorded among participants in the treatment group, including serious events. They are not comparative risk estimates and do not establish causation for the listed events. The registry record does not give detailed event-level information or a control group for contextual comparison.
Finally, the registry status is terminated, but the reason and its consequences for follow-up or analysis are not reported. The record therefore supports a description of the intended regimen, endpoint, and reported safety counts, but not a conclusion about the magnitude of pathologic response, comparative benefit, long-term outcomes, or the cause of termination.
14. Why This Trial Matters Statistically
This study illustrates a common statistical distinction between defining an outcome and reporting its estimate. The registry gives a specific pathologic complete response definition and assessment time, which makes the intended endpoint understandable. Yet it does not report the response numerator, denominator, proportion, or stated 90% confidence interval. Without those values, readers cannot assess either the observed outcome or its statistical precision.
Its single-group structure also makes the design’s inferential limits central. A treated-group response proportion can describe what was observed among participants who meet the analysis definition. It cannot establish the comparative effect of the regimen, because no concurrent control group is recorded. This distinction matters whenever an outcome is interpreted in the context of treatment: an outcome after treatment is not automatically an outcome caused by treatment.
The case also highlights why the analysis population and participant flow matter. The registry names eligible and treated patients as the endpoint population and lists enrollment separately, but does not say how many participants contributed to the endpoint or how unevaluable specimens were handled. Clear reporting of those details would help readers judge whether the estimate represents all participants intended for analysis and how missing observations may affect interpretation.
Safety counts are likewise informative only in context. The record reports participants affected by serious and other adverse events, and identifies several frequent serious-event terms. Without a comparison group or event-level detail, those counts describe observed reporting in the study group rather than relative risk or causation.
Finally, the terminated status makes clear that registry status and statistical results are separate pieces of information. The reason for termination and the primary endpoint result are not reported in the registry record. Statistical interpretation should preserve those uncertainties rather than infer a result from the study’s status or stated objective.
15. 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 principal limitation for interpreting efficacy is the absence of the primary endpoint result. The registry defines pathologic complete response and specifies a 90% confidence interval, but does not report the response count, estimate, or interval. Its precision and observed magnitude therefore cannot be assessed from the registry record.
The study is single-group and has no randomized comparator. Any observed outcome would describe the treated population but would not provide a direct estimate of what would have happened under another treatment strategy. The record does not provide an external comparison or information sufficient to assess comparability with another cohort.
The participant flow and analysis denominator are not reported. Although enrollment is listed as 22, the primary endpoint population is eligible and treated patients, and the number who contributed evaluable surgical specimens is not given. The registry does not explain whether any participants were excluded, did not undergo surgery, or had missing pathology assessments. This limits assessment of selection and missing-data concerns.
The registry’s status is terminated, but the reason for termination is not reported. The record also does not explain whether termination affected enrollment, treatment completion, surgery, follow-up, or outcome reporting. The detailed postoperative regimen is not reported, despite the overall description of planned docetaxel and cetuximab after surgery. The reason for the difference between the brief description’s disease population and the official title’s population is also not clarified.
Finally, the registry does not report a detailed statistical analysis plan, an interim-analysis approach, multiplicity procedures, or longer-term outcome results. These gaps constrain interpretation of both the primary endpoint and the safety record. They do not establish that a particular analysis or follow-up activity was absent; they indicate that it is not reported in the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer — NCT00551759.
- Registry record last updated 2023-07-03; status last verified 2023-06.
- Results first posted 2014-02-28.
- 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
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT00551759 is a Phase II, single-group study listed as terminated. Its treatment approach combined neoadjuvant oxaliplatin, infusional 5-fluorouracil, radiotherapy, and cetuximab with surgery and planned postoperative docetaxel and cetuximab. Enrollment is listed as 22.
The primary endpoint was the proportion of eligible and treated patients with pathologic complete response at surgery, defined by no histopathologic evidence of tumor in resected esophageal and nodal tissue. Surgery was described as occurring 63 to 91 days after study entry. The observed endpoint result and its 90% confidence interval are not reported in the registry record.
The registry reports serious adverse events affecting 19 of 22 participants at risk and other adverse events affecting 22 of 22 at risk. The reason for termination, participant flow, endpoint missing-data handling, and detailed analysis plan are not reported in the registry record.