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 Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer (NCT01545141), a randomized phase 1, phase 2 study. The primary outcome is Change in the Number of Tumor-infiltrating CD8+ Cells..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01545141 |
| Phase | Phase 1, Phase 2 |
| Condition | Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Roswell Park Cancer Institute |
| Results posted | Yes |
2. Clinical Question
Population
Patients with recurrent resectable colorectal cancer. The registry record lists an enrollment of 15 and states that the study terminated before Phase II enrollment was complete.
Intervention
A chemokine-modulatory regimen before surgery: celecoxib, IFN by intravenous infusion, and rintatolimod by intravenous infusion. The listed IFN dose levels were 5 MU/m2, 10 MU/m2, and 20 MU/m2.
Comparator
A surgery-only group, described as receiving surgical resection as standard of care for the disease. The trial also included randomized regimen groups at the listed IFN dose levels.
Primary question
Would the regimen be associated with an increase in tumor-infiltrating CD8+ T cells in resected recurrent colorectal cancer lesions, assessed by the CD8 mRNA message relative to the housekeeping gene HPRT? The planned analysis was not completed.
The trial was designed to evaluate safety and whether the combination might help the immune system fight tumors. Its registry summary also describes the aim of identifying a preferred combination for subsequent extended studies. These are stated aims, not findings: the planned T-cell endpoint was not analyzed, and the posted record does not report an efficacy estimate for the primary question.
The registry describes a randomized, open-label, parallel-group Phase 1/2 study. It lists surgery only and three preoperative regimen groups, distinguished by the IFN dose level. The treatment schedules specify celecoxib 400 mg for 5 days, IFN for 5 days, and rintatolimod 200 mg for 5 days, Monday through Friday before surgery. The IFN dose escalation levels are 5 MU/m2, 10 MU/m2, and 20 MU/m2.
Accordingly, the clinical question has two parts: whether the preoperative combination could be given safely in this setting, and whether its administration would be accompanied by a change in the specified immune-cell measure. The registry contains adverse-event counts, but it does not provide the completed endpoint analysis needed to answer the latter question. The reported counts should therefore be read as descriptive safety information, not as a comparison establishing benefit or harm.
3. Trial Design
This was a randomized Phase 1/2, parallel-group study with no masking. The registry lists an enrollment of 15 and identifies the study status as terminated. The listed study start is 2012-10, and the primary completion date is 2016-04-08. The record states that termination occurred before completion of enrollment for Phase II.
The four described groups were surgery only and chemokine-modulatory regimen before surgery at IFN dose levels of 5 MU/m2, 10 MU/m2, and 20 MU/m2. Each regimen description specifies celecoxib 400 mg for 5 days, IFN by intravenous infusion for 5 days at the group’s dose level, and rintatolimod 200 mg by intravenous infusion for 5 days. Treatment was scheduled Monday through Friday before surgery. Surgery alone is described as surgical resection only, performed as standard of care for the disease.
The study’s Phase 1/2 designation and dose-level groups indicate that the record encompasses dose escalation and a planned Phase II component. The record does not report the protocol details needed to describe dose-escalation rules, dose-limiting toxicity definitions, allocation ratios, or the criteria for proceeding to Phase II. Those details are not reported in the registry record and should not be inferred from the existence of the dose groups.
The planned primary outcome was change in the number of tumor-infiltrating CD8+ cells, with assessment on the day of surgery, day 8-10. The registry specifies measurement as the ratio between CD8 mRNA message and expression of the housekeeping gene HPRT, and describes a comparison between Arm A and Arm B. The record also lists treatment-related adverse events as a secondary outcome. It states that the T-cell analysis was not completed because the study terminated before Phase II enrollment was complete.
There are no reported analyses in the registry record. Consequently, the posted information does not give a comparative estimate for the primary outcome or a statistical test of differences between the treatment groups. The adverse-event counts are available as descriptive results, but the record does not report an inferential analysis accompanying them. A sample-size justification, statistical analysis plan, and details of interim monitoring are 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 | Surgery Only | Chemokin Modulatory Regimen (5 MU/m2) | Chemokin Modulatory Regimen (10 MU/m2) | Chemokin Modulatory Regimen (20 MU/m2) |
|---|---|---|---|---|
| STARTED | 2 | 3 | 3 | 7 |
| COMPLETED | 2 | 3 | 3 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The study was terminated prior to completion of enrollment for Phase II and the T-cell analysis was not completed.
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: 9 patients in Phase I 6 patients in Phase II
| Characteristic | Unit | Surgery Only | Chemokine Modulatory Regimen (5 MU/m2) | Chemokine Modulatory Regimen (10 MU/m2) | Chemokine Modulatory Regimen (20 MU/m2) | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 2 | 3 | 3 | 7 | 15 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 1 | 1 | 6 | 9 |
| Age, Categorical: >=65 years | Participants | 1 | 2 | 2 | 1 | 6 |
| Age, Continuous | years | 64.0 (SD 4.2) | 62.7 (SD 13.7) | 60.0 (SD 15.9) | 47.1 (SD 15.3) | 55.1 (SD 15.0) |
| Sex: Female, Male: Female | Participants | 0 | 2 | 0 | 4 | 6 |
| Sex: Female, Male: Male | Participants | 2 | 1 | 3 | 3 | 9 |
| Region of Enrollment: United States | participants | 2 | 3 | 3 | 7 | 15 |
6. Primary Endpoint
The registry lists the primary outcome as Change in the Number of Tumor-infiltrating CD8+ Cells., measured over Day of surgery: day 8-10.
| 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 change in the number of tumor-infiltrating CD8+ cells in resected, recurrent colorectal cancer lesions. The registry describes the measurement as the ratio between the CD8 mRNA message and expression of the housekeeping gene HPRT. Its stated timeframe is the day of surgery: day 8-10. The endpoint description specifies a comparison between Arm A and Arm B, without identifying those arm labels in that description.
The endpoint was intended to capture an immune-cell measure in tumor tissue after the preoperative treatment period. Measuring CD8 mRNA relative to HPRT gives an expression ratio rather than a direct count written as a number of cells. The endpoint title refers to a change in cell number, while the operational description identifies the transcript ratio used to assess it. Interpretation should therefore follow the recorded measurement definition rather than assume that the result would be a literal cell count.
Such a tissue-based measure can address a biological question distinct from clinical outcomes such as tumor response or survival. The registry does not report those outcomes as the primary endpoint, nor does it report the completed CD8/HPRT analysis. It explicitly states that the T-cell analysis was not completed. There is consequently no posted primary-outcome estimate, uncertainty interval, or statistical test with which to judge the size or precision of a change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The strongest limitation on interpretation is that the primary endpoint was not analyzed. Although the registry defines a tissue-based CD8 measure and its assessment timeframe, it says that the T-cell analysis was not completed after termination before Phase II enrollment was complete. The record therefore does not establish whether the planned measure increased, decreased, or remained similar across groups. It also provides no estimate of the magnitude or precision of any such difference.
The registry reports safety counts separately for surgery only and the three regimen dose levels. For serious adverse events, the affected counts are zero among two at risk in surgery only, zero among three at risk in the 5 MU/m2 group, one among three at risk in the 10 MU/m2 group, and one among seven at risk in the 20 MU/m2 group. No deaths are reported in any group. These are descriptive counts from the registry, not a statistical comparison. The small group counts make each individual event consequential to the apparent pattern, and the record does not provide uncertainty intervals or adjusted comparisons for these figures.
For other adverse events, the registry lists zero affected among two at risk for surgery only, three among three at risk for the 5 MU/m2 group, three among three at risk for the 10 MU/m2 group, and six among seven at risk for the 20 MU/m2 group. These entries should not be conflated with serious adverse events: they are reported as a separate category. The record does not give enough detail in these figures alone to assess event severity, duration, attribution, or whether events recur within a participant.
The most frequently listed serious-adverse-event term is neutrophil count decreased, with 33.3% shown in the registry. The record does not attach that percentage to a particular treatment group in the listed top-term entry, so it should not be assigned to one. Nor should it be treated as a comparative risk estimate without the underlying definition and denominator being made explicit.
Randomization can support a fair comparison when the planned groups are adequately enrolled, outcomes are measured consistently, and analysis follows an appropriate plan. Here, the registry reports no analyses and states that the primary T-cell assessment was not completed. The existence of randomization does not fill in missing outcome data or turn descriptive adverse-event counts into evidence of a treatment effect. The reported information supports a limited account of who was assigned to which regimen groups and what adverse-event counts were posted; it does not support conclusions about comparative efficacy.
The study’s termination and incomplete Phase II enrollment also constrain how broadly the posted safety counts can be interpreted. They describe the groups represented in the registry, but the record does not establish that the observations capture the full intended study population or the planned dose-selection process. A preferred dose or regimen cannot be selected from the primary endpoint because that analysis was not completed, and the record does not report a formal selection rule or comparative analysis of safety across dose levels.
9. Statistical Methods Explained
Several design and analysis concepts help distinguish what the record can answer from what it cannot. The following explanations are general statistical context; they are not claims about procedures used in this study unless the registry explicitly reports them.
What does randomization contribute?
In general, randomization assigns participants to study groups using a chance-based process. When implemented as planned, it can reduce systematic differences in measured and unmeasured characteristics between groups at the time of assignment. It does not guarantee that groups will be similar in a small study, and it cannot ensure that every planned outcome is collected or analyzed. In this trial, randomization is reported, but the registry does not report the allocation sequence, allocation concealment, or group allocation ratio. It also does not report a completed analysis of the primary endpoint. Randomization is therefore a design feature, not a substitute for the missing outcome results.
What does an open-label parallel design mean?
In a parallel-group trial, participants are assigned to a group and receive that group’s intervention rather than crossing through all interventions. The registry identifies a parallel model and no masking. In general, lack of masking means that treatment assignment is not concealed from participants or study personnel in the way it would be in a masked study. This can matter for outcomes that involve judgment, reporting, or decisions about care. The primary outcome is described as a laboratory measure from resected tissue, but the record does not explain blinding of laboratory personnel or other safeguards against measurement bias. Those details are not reported in the registry record.
How should the dose groups be understood?
The registry lists three regimen groups with different IFN dose levels, as well as surgery only. A dose-escalation component commonly concerns evaluating treatment at increasing dose levels, but the particular rules used to guide escalation are not reported in the registry record. It would be inappropriate to infer a toxicity threshold, dose-limiting toxicity definition, or a chosen dose from the dose labels alone. The record states that the study ended before Phase II enrollment was complete and does not report the planned process for identifying a preferred combination.
What is an outcome estimate?
An outcome estimate is a numerical summary of what was observed, such as a group mean, a difference between group summaries, or a measure of event frequency. An estimate is more informative when paired with a measure of uncertainty. A confidence interval is a general statistical tool for expressing the range of values compatible with the data and a specified method. It is not a guarantee that the true value lies in that range, and its interpretation depends on the model and design assumptions. The registry reports no analyses for this study and does not provide an estimate or confidence interval for the primary T-cell endpoint.
For adverse events, the posted entries are counts of affected participants and counts at risk for each group. These can describe the observations recorded, but they do not by themselves quantify uncertainty or establish a difference between groups. In small groups, a change in the count of even a single affected participant can alter the descriptive pattern substantially. Formal comparison would need a defined analysis, suitable uncertainty estimates, and clear information about how events and participants were counted. Such analyses are not reported in the registry record.
Why might over-dispersion matter?
In general, over-dispersion occurs when observed variability in count data is greater than would be expected under a statistical model that assumes a more restricted amount of variation. If present, a model that ignores it can understate uncertainty and make evidence appear more precise than it is. This concept is relevant to count outcomes in many studies, but the registry does not provide a count model, event-level data, or an analysis for this trial. There is no basis to say whether over-dispersion was assessed or whether it affected any result.
What does the missing endpoint analysis imply?
Missing outcome information is not equivalent to a measured value showing no change. Here, the registry specifically says the T-cell analysis was not completed. It does not state whether tissue samples were unavailable, measurements were not performed, data were incomplete, or analysis was stopped for another reason. The cause and extent of missing primary-outcome data are not reported in the registry record. Without those details, neither an assumption about the unobserved values nor a correction for missingness can be justified.
General methods for missing data depend on why values are absent, what auxiliary information is available, and which assumptions are defensible. Complete-case analysis, imputation, and sensitivity analysis each answer different questions and rely on different assumptions. The registry does not report that any of these methods was used. Because the primary analysis was not completed, there is no reported primary-outcome estimate to interpret under any of these approaches.
How should sample-size planning be separated from results?
A sample-size calculation is a planning exercise based on assumptions about the outcome, variability, significance level, allocation, and effect size to be detected. It does not show what the study observed, and it is not observed power. The registry’s planning illustration is described as using 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 non-time-to-event outcomes, the illustration is expressed as participants per arm; time-to-event illustrations are expressed as total events.
Those assumptions are not reported as the trial’s own design rationale. The registry does not provide the original sample-size justification or indicate that its planning illustration was used to make study decisions. Moreover, the planned primary analysis was not completed, so a calculation based on an observed primary effect cannot be treated as evidence of the study’s ability to detect a clinically meaningful difference. Planning scenarios, observed outcomes, and statistical power are distinct concepts.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study makes several statistical comparisons or evaluates several outcomes, because repeated testing can increase the chance of obtaining an apparently notable result by chance. General approaches include selecting a primary comparison in advance, adjusting the interpretation of multiple tests, or treating secondary analyses as exploratory. The registry identifies a primary endpoint and a secondary outcome of treatment-related adverse events, and it lists two outcome measures. It does not report a multiplicity strategy or a statistical analysis plan. Any correction, hierarchy, or prespecified handling of multiple comparisons is therefore not reported in the registry record.
The primary endpoint description names a comparison between Arm A and Arm B, while the intervention descriptions list surgery only and three regimen dose levels. The record does not explain the mapping of those arm labels in the primary outcome description. It also does not report whether comparisons across all groups, selected dose groups, or other contrasts were planned. No specific comparison should be assumed beyond what is stated.
The registry states that the T-cell analysis was not completed. It does not explain the amount or reason for missing primary-outcome information, whether tissue was collected from all relevant participants, or whether any missing-data procedure was used. Handling missing outcomes can affect interpretation because statistical methods rely on assumptions about why data are absent. Those assumptions and any sensitivity analysis are not reported in the registry record.
Analysis populations are also not described. The registry does not specify whether an intention-to-treat, per-protocol, safety, or other population was used for an analysis. The adverse-event entries include group-specific counts at risk, but the record does not explain eligibility for those denominators, follow-up completeness, or participant-level event counting rules. These omissions limit the ability to assess whether the posted figures represent all randomized participants or a defined analysis set. No analysis population or multiplicity adjustment can be inferred from the group counts alone.
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 |
|---|---|---|---|
| Surgery Only | 0 | 2 | 0.0% |
| Chemokin Modulatory Regimen Prior to Surgery (5 MU/m2) | 0 | 3 | 0.0% |
| Chemokin Modulatory Regimen Prior to Surgery (10 MU/m2) | 1 | 3 | 33.3% |
| Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2) | 1 | 7 | 14.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Surgery Only | 0 of 2 |
| Chemokin Modulatory Regimen Prior to Surgery (5 MU/m2) | 0 of 3 |
| Chemokin Modulatory Regimen Prior to Surgery (10 MU/m2) | 0 of 3 |
| Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2) | 0 of 7 |
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 |
|---|---|
| Surgery Only | 0 of 2 |
| Chemokin Modulatory Regimen Prior to Surgery (5 MU/m2) | 3 of 3 |
| Chemokin Modulatory Regimen Prior to Surgery (10 MU/m2) | 3 of 3 |
| Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2) | 6 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Surgery Only | Chemokin Modulatory Regimen Prior to Surgery (5 MU/m2) | Chemokin Modulatory Regimen Prior to Surgery (10 MU/m2) | Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2) |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | 0 of 2 | 0 of 3 | 1 of 3 | 1 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Surgery Only | Chemokin Modulatory Regimen Prior to Surgery (5 MU/m2) | Chemokin Modulatory Regimen Prior to Surgery (10 MU/m2) | Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2) |
|---|---|---|---|---|---|
| Chills | General disorders | 0 of 2 | 3 of 3 | 3 of 3 | 3 of 7 |
| Nausea | Gastrointestinal disorders | 0 of 2 | 3 of 3 | 1 of 3 | 3 of 7 |
| Neutrophil count decreased | Investigations | 0 of 2 | 1 of 3 | 3 of 3 | 3 of 7 |
| White blood cell decreased | Investigations | 0 of 2 | 2 of 3 | 3 of 3 | 2 of 7 |
| Anemia | Blood and lymphatic system disorders | 0 of 2 | 3 of 3 | 1 of 3 | 2 of 7 |
| Fatigue | General disorders | 0 of 2 | 0 of 3 | 2 of 3 | 4 of 7 |
| Platelet count decreased | Investigations | 0 of 2 | 3 of 3 | 1 of 3 | 1 of 7 |
| Dehydration | Metabolism and nutrition disorders | 0 of 2 | 2 of 3 | 2 of 3 | 0 of 7 |
| Hypertension | Vascular disorders | 0 of 2 | 2 of 3 | 2 of 3 | 0 of 7 |
| Vomiting | Gastrointestinal disorders | 0 of 2 | 1 of 3 | 0 of 3 | 2 of 7 |
Serious events with the highest arm-level rate: neutrophil count decreased (33.3%).
The registry reports serious adverse-event counts by group, with separate counts at risk. Surgery only lists zero affected among two at risk; the 5 MU/m2 regimen group lists zero among three; the 10 MU/m2 group lists one among three; and the 20 MU/m2 group lists one among seven. The record reports zero deaths in each group. These are descriptive entries and should not be read as proof that a regimen caused, prevented, or changed the risk of an event.
The separate other-adverse-event entries are zero affected among two at risk for surgery only, three among three at risk for the 5 MU/m2 group, three among three at risk for the 10 MU/m2 group, and six among seven at risk for the 20 MU/m2 group. Serious and other adverse events are separate registry categories; the figures should not be combined. The record does not report event-level timing, duration, severity details beyond the category, attribution, or recurrence information in these entries.
Neutrophil count decreased is listed as a top serious adverse-event term at 33.3%. The record does not identify a group-specific denominator in that top-term entry. With the small group counts and no comparative analysis or uncertainty estimates, the entries are best treated as a descriptive account of the reported observations, not as a precise estimate of comparative safety.
12. What the Result Does, and Does Not, Mean
The record documents a randomized, open-label, parallel Phase 1/2 study of a preoperative chemokine-modulatory regimen at three IFN dose levels alongside a surgery-only group. It also documents the planned primary biological endpoint, the treatment schedule, the termination status, and adverse-event counts by group. These details describe the trial and the information available in the registry; they do not establish that the regimen changed tumor-infiltrating CD8+ cells.
The primary outcome was intended to assess CD8 mRNA relative to HPRT in resected lesions at the day-of-surgery timeframe. The registry explicitly says the T-cell analysis was not completed. It follows that the posted record does not offer an estimate of the primary outcome, a confidence interval, or a test comparing groups. A missing analysis cannot be interpreted as a null result, and it cannot support a claim that the outcome increased or decreased.
The adverse-event entries show the counts recorded in each group, including serious events, other events, and the absence of reported deaths. They do not, on their own, determine whether the regimen caused an event or whether event rates differed between treatment groups. The record provides no inferential safety comparison and no uncertainty estimates. The top serious-event term is listed with a percentage, but its group-specific denominator is not stated in that entry.
The trial’s planned aim included identifying a preferred combination for later extended studies. The registry does not report a completed comparison or decision rule that would support selection of a preferred dose. Nor does it report a completed Phase II evaluation. The dose levels should therefore be understood as the groups studied, not as a ranked set of established options.
More broadly, the record cannot answer questions about clinical effectiveness, durability of response, survival, or the comparative benefit-harm balance, because such results are not reported in the material available. The study’s stated biological rationale and the purpose described in the summary are not evidence of an observed effect. Conclusions should remain limited to the trial design and the descriptive safety information actually reported.
13. Why This Trial Matters Statistically
This trial illustrates why a registry record must be read as more than a list of interventions and outcome names. The design defines a randomized comparison, a surgery-only group, and regimen groups with distinct IFN dose levels. But a planned endpoint contributes evidence only when it is measured, analyzed, and reported. The registry states that its primary T-cell analysis was not completed, so the central biological question remains unanswered in the posted record.
The distinction between endpoint definition and endpoint result is important. A carefully specified biomarker can make the intended question clearer, including the tissue, measurement, and assessment timeframe. Yet the ratio of CD8 mRNA to HPRT is not itself a result. Without an estimate and information about its uncertainty, readers cannot assess the direction, magnitude, or precision of a group difference.
The adverse-event entries also show why counts need context. The registry reports group-specific numbers at risk and affected, but counts alone do not establish causality or support a reliable comparative safety estimate. Small groups are especially vulnerable to unstable descriptive patterns. Event definitions, follow-up, attribution, analysis populations, and uncertainty estimates matter when moving from counts to a comparison.
Finally, the terminated status and incomplete Phase II enrollment are relevant to the scope of inference. The record does not explain the termination circumstances or report the original statistical plan. Readers therefore cannot determine from the registry whether the planned dose-selection process was completed or how the study would have handled multiple comparisons and missing outcomes. This makes transparent separation of stated aims, posted observations, and unavailable analyses especially important.
The statistical lesson is not that the trial’s question lacks value, but that a design and an intended endpoint do not replace completed data and analysis. The record supports a descriptive account of the study and reported adverse events. It does not support a conclusion about the primary immune endpoint or a definitive ranking of regimens.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct trial-specific limitation is early termination before completion of Phase II enrollment, with the registry stating that the T-cell analysis was not completed. The record does not explain the reason for termination or whether any primary endpoint measurements were collected but left unanalyzed. It also does not report the extent or pattern of missing outcome information. Those gaps prevent an assessment of selection or missing-data bias.
The listed enrollment is 15, while the adverse-event groups have small counts at risk. Such limited group counts make estimates inherently uncertain and leave little room for stable comparisons. However, the registry does not report confidence intervals, hypothesis tests, or a completed safety analysis. No comparative statistical conclusion can be reconstructed from the counts without making assumptions that the record does not support.
The study was unmasked, and the registry does not report whether outcome assessors or laboratory personnel were masked to assignment. It also does not provide details about endpoint assay procedures, quality control, or handling of tissue samples. These measurement details matter for interpreting a biomarker endpoint, but their absence from the registry does not establish that safeguards were or were not used.
The primary outcome description names Arm A and Arm B without identifying those labels in that description. The registry also does not report the allocation ratio, analysis population, sample-size justification, multiplicity plan, or missing-data strategy. These omissions limit assessment of whether the intended comparison was fully prespecified and how results would have been interpreted. The record does not report interim analysis procedures or dose-escalation decision rules either.
Finally, the adverse-event summary is not a full account of event-level data. It does not specify timing, duration, repeated events, attribution, or follow-up completeness in the listed figures. The 33.3% serious-event term entry lacks a stated group denominator in that entry. These limitations make the counts useful as a narrow descriptive record, not as a complete safety profile or as a basis for comparing dose levels.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer — NCT01545141.
- Registry record last updated 2023-10-27; status last verified 2023-10.
- Results first posted 2020-09-09.
- 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
NCT01545141 is a randomized, open-label, parallel Phase 1/2 study of a chemokine-modulatory regimen before surgery for recurrent resectable colorectal cancer. The registry lists an enrollment of 15, a status of terminated, a start of 2012-10, and a primary completion date of 2016-04-08. It states that termination occurred before Phase II enrollment was complete.
The study groups were surgery only and preoperative regimens with IFN dose levels of 5 MU/m2, 10 MU/m2, and 20 MU/m2, alongside celecoxib and rintatolimod. The primary endpoint was a tumor-tissue CD8 mRNA-to-HPRT measure, assessed on the day of surgery: day 8-10. The registry says the T-cell analysis was not completed and reports no analyses.
Adverse-event counts are reported by group, including serious and other events and zero deaths in each group. These entries are descriptive; the registry does not report comparative safety estimates or uncertainty intervals. A statistical analysis plan, sample-size justification, missing-data approach, and multiplicity strategy are not reported in the registry record.