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 Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer (NCT01285102), a na phase 1 study. The primary outcome is Time to Progression.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01285102 |
| Phase | Phase 1 |
| Condition | Liver Metastases, Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Fox Chase Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with refractory metastatic colorectal cancer and liver-only or liver-predominant disease, as described in the official title. The listed conditions include liver metastases, recurrent and stage IV colon or rectal cancer, and specified mucinous or signet ring adenocarcinomas. The registry reports enrollment of 4.
Intervention
The intervention combined irinotecan-eluting beads with hepatic artery embolization. The arm description says that patients received the beads through hepatic artery embolization every 3 weeks, for up to 3 courses with unilobar disease or 4 courses with bi-lobar disease, if progression or unacceptable toxicity did not occur.
Comparator
The registry describes a single-group study, with allocation listed as NA. It does not identify a separate control arm or a randomized comparison. The results therefore cannot provide a like-for-like estimate of the intervention relative to another treatment or to no intervention.
Primary question
The primary endpoint was time to progression, defined in the record as duration from start of treatment to progression. The central question was how this interval would be characterized in the enrolled study population. The registry states that the sponsor closed the study to accrual because of poor accrual and challenges with dosing, and that no data was generated for this endpoint.
The official title identifies the study as a Phase II study, while the registry’s phase listing is PHASE1. The record does not explain this difference. The title and stated purpose describe investigation of chemoembolization using irinotecan in patients with liver metastases from colon or rectal cancer; however, without generated primary-endpoint data, the registry does not answer how long participants remained free from progression.
3. Trial Design
This was a single-group intervention study sponsored by Fox Chase Cancer Center. Allocation is listed as NA, and the design field identifies a single-group model. Masking is listed as NONE. These entries describe a study without a randomized, masked comparison group in the registry record; they do not establish what procedures, if any, were used to reduce bias in individual outcome assessments.
The intervention consisted of irinotecan-eluting beads administered through hepatic artery embolization. The arm description specifies administration every 3 weeks, with up to 3 courses for unilobar disease or 4 courses for bi-lobar disease, provided there was no disease progression or unacceptable toxicity. The registry does not report how many participants received each course, whether participants completed the intended treatment, or what dosing challenges occurred.
The record lists a start date of 2010-10 and primary completion of 2011-12. It reports enrollment of 4 and status TERMINATED. The sponsor closed the study to accrual because of poor accrual and challenges with dosing. The registry does not report a detailed account of the termination decision, the timing of that decision, or whether any follow-up continued after accrual closed.
The official title calls this a Phase II study, but the phase listing is PHASE1. That discrepancy is present in the registry, and its reason is not reported in the registry record. The record identifies 3 outcome measures but reports no analyses. It does not provide the planned statistical analysis, a sample-size justification, an interim-analysis plan, or a description of any protocol amendments. Because the design has no listed comparator, the results cannot support a randomized between-group treatment contrast.
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 | DEBIRI With Hepatic Artery Embolization |
|---|---|
| STARTED | 4 |
| COMPLETED | 0 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | DEBIRI With Hepatic Artery Embolization |
|---|---|
| Closed to accrual by sponsor due to poor accrual and challenge with dosing | 4 |
Analysis population for the primary outcome, as defined in the registry: Study was closed to accrual by sponsor due to poor accrual and challenge with dosing. No data was generated.
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 | DEBIRI With Hepatic Artery Embolization |
|---|---|---|
| Participants analysed | 4 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 3 |
| Age, Continuous | years | 77.5 (60 to 86) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 2 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Progression, measured over Duration of time from start of treatment to progression.
| 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 time to progression. The registry defines the timeframe as the duration from the start of treatment to progression. This is a time-to-event endpoint: it concerns the amount of time until a specified event, rather than simply whether that event occurred at one fixed assessment. The event of interest in this record is progression.
General statistical context: time-to-event endpoints can retain information about when an event occurs, and can account for participants whose event time is not observed during follow-up through censoring methods. Such methods require a definition of the event, follow-up information, and rules for handling observations without a recorded event. The registry record does not describe progression criteria, assessment timing, censoring rules, or an analysis method.
The registry states that the study was closed to accrual by the sponsor because of poor accrual and challenges with dosing, and that no data was generated for the primary endpoint. Consequently, it reports no time-to-progression estimate, event count, confidence interval, or other primary-endpoint result. The endpoint’s purpose can be described, but its observed distribution and precision cannot be evaluated from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main interpretive fact is that the primary endpoint has no reported result. Although time to progression was specified as the primary outcome, the registry says that no data was generated for it. There is therefore no reported estimate of the interval from treatment start to progression, and no basis in the registry record for describing the endpoint’s observed pattern or its precision.
The record reports enrollment of 4 and a terminated status. It attributes closure to poor accrual and challenges with dosing. This information explains why the registry does not present a primary-endpoint analysis, but it does not establish the clinical course of the enrolled participants or the reason for any individual outcome. No analysis is listed, and the record does not provide participant-level follow-up or progression results.
The design also limits the kinds of conclusions that could be made even if an outcome estimate were available. This was a single-group study without a listed randomized comparator. A result from one group can describe outcomes observed in that group, but it cannot by itself distinguish an intervention effect from other explanations for those outcomes. The registry does not report a comparative effect estimate.
General statistical context: an estimate should be read together with its uncertainty. A confidence interval, when reported, expresses a range of values compatible with the data and the stated statistical procedure; it is not a guarantee that the true value lies within that particular interval. No confidence interval is reported for time to progression in this record. With no primary-endpoint data, neither the size of an estimate nor its uncertainty can be assessed.
The adverse-event fields list 0 serious adverse events among 4 participants at risk, 4 participants with other adverse events among 4 at risk, and 4 deaths. These counts are distinct from a time-to-progression result. The registry does not state the causes or timing of deaths, whether any death was related to the intervention, or how deaths were handled in relation to the primary endpoint. The available safety counts should therefore be read narrowly as registry entries, not as evidence of a causal relationship.
Overall, the record documents a small, terminated study and its stated reason for closure, but it does not provide generated primary-endpoint data or an analysis from which an intervention effect can be estimated. The absence of a result is not evidence that progression did or did not occur at a particular time, and it does not establish whether the intervention was beneficial or harmful.
9. Statistical Methods Explained
The registry identifies time to progression as the primary endpoint and gives its timeframe as duration from treatment start to progression. It does not report an analysis for this endpoint. The statistical methods that might ordinarily be used for a time-to-event outcome should therefore be understood as general concepts, not as methods confirmed for this study.
What does a time-to-event endpoint represent?
General statistical explanation: a time-to-event outcome records the time until a defined event, such as progression. A statistical summary might describe the distribution of event times or compare event timing between groups. The event definition matters: investigators need rules for deciding whether progression has occurred and when its date is assigned. The registry record does not report those rules or the criteria used to assess progression.
Some participants in a time-to-event study may have no recorded event by the end of their available follow-up. General methods can treat their observed follow-up as censored, meaning the event time is known to extend beyond the last observed time but is not known exactly. Analyses then rely on follow-up information and assumptions about how censoring relates to the event process. The registry does not report follow-up durations, censoring information, or the assumptions and methods used. In any case, it explicitly states that no data was generated for the primary endpoint.
Why does the single-group design matter?
General statistical explanation: a single-group outcome can describe what happened among the participants observed in that group, but there is no concurrent randomized group to provide a direct treatment contrast. Without such a comparison, differences between observed outcomes and what might have occurred under another treatment cannot be isolated from other influences. This study’s allocation is listed as NA, and its model is single group. The registry therefore does not support a randomized comparison.
Masking is listed as NONE. General statistical context: masking can reduce the influence of expectations on treatment delivery, assessment, or reporting, depending on who is masked and how outcomes are measured. The registry does not describe an outcome-assessment process or any steps used to limit assessment bias. Since progression was the primary endpoint but no endpoint data was generated, the record gives no basis for evaluating how assessment procedures affected an estimate.
What can an estimate and confidence interval tell a reader?
General statistical explanation: an estimate is a concise summary of data, while a confidence interval communicates statistical uncertainty under a specified method and its assumptions. Wider intervals generally indicate less precision than narrower intervals, although an interval should be interpreted in the context of the outcome, design, and analysis. A confidence interval does not repair limitations such as lack of a comparator or incomplete outcome information. The registry reports no primary-endpoint estimate or interval, so precision cannot be assessed.
A p-value, if reported, would address how compatible the data are with a specified null hypothesis under the analysis assumptions; it would not measure the probability that a treatment works. No p-value or primary-endpoint analysis is reported in this record. The registry lists 0 analyses. It also does not report whether any analysis was planned but not performed, or whether analyses were conducted outside the registry record.
What do the registry entries establish?
The record reports enrollment of 4 and says the sponsor closed the study to accrual because of poor accrual and challenges with dosing. It does not report a sample-size justification or the assumptions used to plan enrollment. A planning calculation is not an observed study result and cannot replace outcome data. In particular, no observed primary-endpoint effect is available in the record to ground an effect-based planning illustration. Such illustrations, when presented, are planning scenarios rather than observed power or evidence that the study tested a particular effect successfully.
The record lists 3 outcome measures but does not give results for the primary endpoint. It does not provide an analysis population, handling of missing observations, event adjudication procedures, a statistical model, or adjustment methods. These omissions mean that a reader cannot reconstruct an analysis or judge whether it followed a prespecified plan. The registry entry is informative about the study’s design and closure, but it does not supply the data and methods needed for an inferential result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures and identifies time to progression as the primary endpoint. It reports 0 analyses. The titles and results for the other outcome measures are not described in the record summarized for this study, and no results are available for the primary endpoint. The registry does not report whether a multiplicity strategy was planned or used.
General statistical context: when investigators test or estimate several outcomes, multiple comparisons can increase the chance of finding an apparently notable result by chance. A prespecified approach can clarify which outcome is primary and how other results should be interpreted. Here, the record names a primary endpoint, but does not report a multiplicity adjustment, hierarchy of secondary outcomes, or analysis plan. With no primary-endpoint data or analyses, there is no set of reported inferential findings for which multiplicity can be evaluated.
The registry does not describe an analysis population, inclusion rules for an endpoint analysis, or how missing observations were handled. It states that no data was generated for time to progression. That statement should not be replaced with assumptions about whether participants were followed, whether records were incomplete, or why endpoint data were unavailable; those details are not reported in the registry record.
General statistical context: missingness can affect interpretation when the availability of outcome information is related to participant characteristics or outcomes. Handling missing data requires information about what is missing, why it is missing, and the intended analysis. The record does not provide these details, nor does it report sensitivity analyses. Consequently, an analysis population and the consequences of missing endpoint information cannot be assessed.
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 |
|---|---|---|---|
| DEBIRI With Hepatic Artery Embolization | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| DEBIRI With Hepatic Artery Embolization | 4 of 4 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| DEBIRI With Hepatic Artery Embolization | 4 of 4 |
Most frequent non-serious adverse event terms
| Event term | Organ system | DEBIRI With Hepatic Artery Embolization |
|---|---|---|
| Elevated ALP | Gastrointestinal disorders | 4 of 4 |
| Elevated AST | Gastrointestinal disorders | 4 of 4 |
| Elevated ALT | Gastrointestinal disorders | 4 of 4 |
| Elevated bilirubin | Gastrointestinal disorders | 3 of 4 |
| Biliary obstruction | Gastrointestinal disorders | 1 of 4 |
The registry’s safety fields report 0 serious adverse events among 4 participants at risk. They also report other adverse events in 4 participants among 4 at risk, and 4 deaths. No serious adverse-event terms are listed. These figures are counts, not estimates of comparative risk, because the study has a single group and no listed control arm.
The categories should be kept distinct. The “other adverse events” count records participants affected, but the record does not list the event terms or describe their severity. The label “other” should not be read as meaning mild. The serious-event count is separately reported as zero. The deaths count is another registry entry; the record does not give causes, timing, or attribution, and does not state whether deaths were considered related to the intervention.
These safety counts do not resolve the missing primary endpoint. The record states that no data was generated for time to progression, while separately listing adverse-event and death counts. It does not explain how these outcomes were collected or how death was treated in the time-to-progression analysis. The counts should therefore be interpreted descriptively and with the reporting limitations in mind, not as evidence of causation or as a treatment comparison.
12. What the Result Does, and Does Not, Mean
The record documents an attempted single-group study of irinotecan-eluting beads administered through hepatic artery embolization for refractory metastatic colorectal cancer with liver-only or liver-predominant disease. It records enrollment of 4 and a terminated status. The stated reason for closure was poor accrual and challenges with dosing. The primary endpoint was time to progression, but the registry says that no data was generated for it.
Accordingly, the record does not establish an observed time to progression, an effect estimate, or the precision of an estimate. It does not show whether the intended dosing schedule was completed by participants or describe their progression outcomes. The listed adverse-event counts provide limited descriptive information, but the record gives neither event terms nor attribution and timing details for deaths.
The design further constrains interpretation. With a single group and no listed randomized comparator, the registry cannot support a direct comparison with another treatment. Even a reported outcome for this group would not, by itself, distinguish the intervention’s contribution from other factors. In this case, the absence of primary-endpoint data means even a group-level time-to-progression description is unavailable.
General statistical context: a study can be informative about feasibility and reporting even when it does not yield an endpoint analysis. Here, the termination reason recorded by the sponsor points to accrual and dosing challenges as issues encountered in conducting the study. The record does not provide enough detail to determine their causes or broader implications.
The record does not establish that the intervention works, does not work, is safe, or is unsafe. It establishes that the study was registered with a specified intervention and endpoint, enrolled 4, was terminated, and had no generated data for the primary endpoint. Those distinctions are important: no reported efficacy estimate is not the same as an estimate showing no effect, and safety counts without causal attribution do not establish a treatment-related harm.
13. Why This Trial Matters Statistically
This study illustrates why design and outcome availability matter as much as an endpoint label. Time to progression was identified as the primary endpoint, but the registry states that no data was generated for it. Without an endpoint estimate, event information, and follow-up details, a reader cannot assess either the outcome pattern or its precision. A stated primary question is not itself evidence answering that question.
The single-group structure also matters. A one-arm study can describe outcomes in the treated group if those outcomes are collected and analyzed, but it does not create a randomized reference for estimating a comparative effect. This record has neither a listed control group nor a primary-endpoint analysis. The interpretation must remain narrower than a treatment comparison.
The enrollment of 4 and the sponsor’s stated reasons for closure—poor accrual and challenges with dosing—make conduct and feasibility part of the statistical context. The record does not report a sample-size justification, planned recruitment target, or detailed dosing experience, so further conclusions about feasibility cannot be drawn. Nor can the lack of an endpoint result be converted into a finding of no progression or no effect.
Finally, the registry includes safety counts, while leaving important details such as event terms and death attribution unreported. Reading these entries alongside the missing primary outcome demonstrates the need to distinguish available descriptive counts from an analyzed endpoint. The record is statistically important as an example of a registered study whose design and closure are documented but whose primary efficacy question remains unanswered in the registry.
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 limitation is that the registry reports no data generated for the primary endpoint. There is no time-to-progression estimate, event count, confidence interval, or analysis to interpret. The record also lists 0 analyses, so statistical findings cannot be reconstructed from the registry entry.
The study enrolled 4 and was terminated after the sponsor cited poor accrual and challenges with dosing. The record does not report a detailed recruitment history, actual dosing received by each participant, treatment completion, follow-up duration, or the timing and basis of termination. These omissions prevent a fuller assessment of study conduct.
The design is single group, with allocation listed as NA and masking as NONE. No comparator is listed, limiting any potential result to description of the study group rather than a randomized treatment contrast. The registry does not report progression criteria, outcome assessment procedures, censoring rules, analysis populations, or handling of missing observations.
Although 3 outcome measures are listed, the record does not provide analyses or explain whether multiplicity was considered. It does not report the sample-size justification, statistical analysis plan, interim analyses, or protocol changes. The official title describes a Phase II study, whereas the phase listing is PHASE1; the record does not explain this discrepancy.
Safety interpretation is also limited. The registry gives counts for serious events, other adverse events, and deaths, but does not list event terms or describe death timing and attribution. These counts cannot be interpreted as causal evidence. Overall, the registry supports a description of the registered design, enrollment, termination reason, and limited outcome fields, but not an efficacy conclusion.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer — NCT01285102.
- Registry record last updated 2021-12-20; status last verified 2021-12.
- Results first posted 2021-12-20.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record is NCT01285102, sponsored by Fox Chase Cancer Center. Its official title is “Phase II Study of Drug-eluting Irinotecan Beads (DEBIRI) in Refractory Metastatic Colorectal Cancer With Liver-only or Liver-predominant Disease.” The intervention combined irinotecan-eluting beads with hepatic artery embolization in a single-group study with no masking.
The record lists a start date of 2010-10, primary completion of 2011-12, enrollment of 4, and status TERMINATED. The sponsor closed the study to accrual because of poor accrual and challenges with dosing. Time to progression was the primary endpoint, but the record states that no data was generated for it. It lists 3 outcome measures and 0 analyses.
The phase listing is PHASE1, although the official title calls the study Phase II. The record does not explain the difference. Safety entries report 0 serious adverse events among 4 participants at risk, other adverse events among 4 of 4, and 4 deaths; causes and attribution are not reported.