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 Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma (NCT01360593), a na phase 2 study. The primary outcome is Local Progression-free Survival (LPFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01360593 |
| Phase | Phase 2 |
| Condition | Pancreatic Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | David A. Clump, MD, PhD |
| Results posted | Yes |
2. Clinical Question
The study asked whether local progression-free survival could be characterized after induction gemcitabine and capecitabine followed by stereotactic body radiation therapy (SBRT) in people with locally advanced pancreatic adenocarcinoma. The registry describes the intended population as potentially resectable, locally advanced disease and identifies patients able to be evaluated for response after study treatment as the primary-outcome population.
Population
Patients with locally advanced pancreatic adenocarcinoma; the primary-outcome population is patients able to be evaluated for response after study treatment. Further eligibility details are not reported in the registry record.
Intervention
Gemcitabine and capecitabine as induction therapy, followed by stereotactic body radiation therapy (SBRT).
Comparator
None. The registry lists a single-group study, with allocation recorded as NA; it does not describe a concurrent control group.
Primary question
What is the median local progression-free survival, measured from enrollment to documented progression in the target lesion under the registry's event definition?
This is a treatment-sequence question within one study group, not a randomized comparison of treatment strategies. The registry also lists response, overall survival, time to progression, quality of life, resection, and toxicity outcomes. Those outcomes broaden the clinical description, but they do not create a control group or establish how outcomes compare with another treatment. The record reports an enrollment of 35, but does not give the number of participants included in the primary-outcome analysis or the primary-outcome estimate. Consequently, the clinical question is identifiable, while its numerical answer cannot be read from the registry record.
3. Trial Design
This completed study is registered as phase 2 and uses a single-group model. Allocation is recorded as NA and masking as none. The intervention sequence is induction gemcitabine and capecitabine followed by SBRT, as reflected in the study title and intervention descriptions. The record describes a prospective evaluation in patients with locally advanced pancreatic cancer. It reports an enrollment of 35.
Because there is one study group and no concurrent comparator, outcomes describe participants receiving the listed sequence; they do not estimate a randomized treatment contrast. The registry does not report a control arm or a procedure for assigning participants among groups. The sample-size illustration associated with the posted material uses hypothetical two-arm planning assumptions, which do not turn this single-group study into a two-arm comparison.
The primary outcome is local progression-free survival (LPFS), with a timeframe of up to 32 months. Its stated analysis population is patients able to be evaluated for response after study treatment. The registry separately lists outcomes for objective response after neoadjuvant chemotherapy and after chemotherapy and SBRT, overall survival, time to progression, FACT-G, margin-negative resection, and acute and late SBRT toxicities. It records 10 outcome measures, but the details of the other outcome definitions and their analysis populations are not fully stated in the registry record for this account.
The registry status is completed. The start date is 2011-07-25, and primary completion is recorded as 2016-03-13. Eligibility criteria beyond the general disease description, treatment doses and schedule, and the number of participants who received each component are not reported in the registry record. Nor does the record give details that would allow assessment of how treatment delivery or follow-up varied among participants.
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 | Gem + Xeloda + SBRT |
|---|---|
| STARTED | 35 |
| COMPLETED | 35 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Patients able to be evaluated for response after study treatment.
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: Patients that received study treatment.
| Characteristic | Unit | Gem + Xeloda + SBRT |
|---|---|---|
| Participants analysed | 34 | |
| Age, Continuous | years | 70.49 (SD 7.66) |
| Sex: Female, Male: Female | Participants | 20 |
| Sex: Female, Male: Male | Participants | 14 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| 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 | 32 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| ECOG Performance Status: ECOG Score of 0 | Participants | 14 |
| ECOG Performance Status: ECOG Score of 1 | Participants | 20 |
| Karnofsky Performance Status | units on a scale | 89.12 (SD 9.65) |
| Body Mass Index (BMI) | kg/m^2 | 27.10 (SD 8.8) |
6. Primary Endpoint
The registry lists the primary outcome as Local Progression-free Survival (LPFS), measured over Up to 32 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is local progression-free survival (LPFS), reported as a median with a 95% confidence interval. It measures time from enrollment to the first documentation of progressive disease in the target lesion. For participants who undergo surgical resection, local progression is defined as recurrence detected on follow-up CT or FDG-PET/CT imaging within the SBRT target volume. Under the registry definition, death and development of distant disease are not LPFS events.
The endpoint focuses on progression in the treated local area rather than on every possible form of disease worsening. This makes the event definition important: a distant event or death does not count as an LPFS event under the stated rule, even though such events may be clinically important and are represented in other outcomes. The registry uses RECIST v1.0 for progressive disease, defining it as at least a 25% increase in the longest diameter of a lesion, using as reference the longest diameter recorded since treatment started.
Time-to-event endpoints can account for different lengths of observation by using the timing of events and censoring participants whose event status is not observed through the end of follow-up. That is a general feature of survival analysis; the registry record does not describe the censoring rules or analysis implementation used for this endpoint. Although the primary endpoint's intended summary and timeframe are stated, its median and confidence interval are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies median LPFS and a 95% confidence interval as the primary-outcome summaries, but neither numerical result is reported in the record. There is therefore no posted primary estimate to interpret for its magnitude or precision. The stated follow-up timeframe is up to 32 months, and the primary-outcome population is described as patients able to be evaluated for response after study treatment. The number included in that population is not reported in the registry record.
A median time-to-event estimate would describe the point at which the estimated event-free experience reaches its median under the specified endpoint and analysis. A confidence interval would communicate uncertainty around that estimate. These are general interpretations; without the actual estimate and interval, the record does not support a conclusion about the observed duration of LPFS or how precisely it was estimated. The endpoint also has a specific scope: distant disease and death do not count as LPFS events under the registry definition. LPFS should therefore not be read as a measure of all disease progression or overall survival.
The trial's single-group design limits comparisons. An outcome observed in the gemcitabine/capecitabine-plus-SBRT group cannot by itself show how the same population would have fared under another strategy. Differences between this group and outcomes from other settings could reflect differences in participants, eligibility, follow-up, outcome definitions, or other factors. A randomized control group is not described in the registry.
The record lists additional outcomes, including response at different treatment stages, overall survival, time to progression, FACT-G, margin-negative resection, and acute and late toxicity. Their presence indicates a broader range of questions, but the corresponding numerical results are not included in the registry record for this account. The registry records zero analyses. It does not report sponsor hazard ratios or other inferential estimates. Accordingly, neither the primary endpoint nor the listed secondary outcomes can be used from this record to quantify comparative benefit or harm.
Adverse-event entries describe recorded counts and terms, not causal attribution. The record lists serious events and other events in the treatment group, as well as deaths, but the listed information does not establish whether an event was caused by a particular treatment component. These safety data should be read as descriptive registry reporting, not as a comparison against an untreated or alternative-treatment group.
The available information supports a careful description of the study design, endpoint definition, and recorded safety figures. It does not supply a numerical primary result with which to judge its magnitude, uncertainty, or relation to a comparator. The registry's completion status does not fill that reporting gap.
9. Statistical Methods Explained
LPFS is a time-to-event outcome. In general, time-to-event methods combine information about when an event occurs with information about participants whose event has not been observed by the end of their available follow-up. The latter observations are commonly called censored. Censoring is not the same as an event; it indicates that the event time is not fully known within the observed period. The registry record does not report the censoring rules or the specific estimator used for LPFS.
What does the median represent?
In general, a median time-to-event estimate is the time by which the estimated event-free proportion has reached the halfway point. It is a summary of the event-time distribution, not an average of all observed follow-up times. Its interpretation depends on the endpoint definition, observation process, and analysis population. Here, the endpoint is local progression as defined for the target lesion, and the stated population is patients able to be evaluated for response after study treatment. The numerical median is not reported in the registry record.
What does a confidence interval add?
In general, a confidence interval represents statistical uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, but the interval does not remove design limitations or establish a causal treatment effect. The registry specifies a 95% confidence interval as the intended dispersion measure for median LPFS, but does not report its bounds. Precision therefore cannot be assessed from the record.
Why does the event definition matter?
Time-to-event analysis depends on what counts as an event. The registry counts documented progression in the target lesion, with a specified recurrence rule for participants who undergo surgery. It explicitly does not count death or distant disease as an LPFS event. This endpoint can therefore differ from measures that include death or progression anywhere in the body. The registry's RECIST v1.0 rule defines progressive disease as at least a 25% increase in the longest diameter, relative to the longest diameter recorded since treatment started. These definition details determine which observations contribute as events.
What can a single-group design estimate?
In general, a single-group study can describe outcomes among participants who received the study regimen. Without a comparator group, it cannot directly estimate the difference between that regimen and another treatment strategy. Participants' outcomes can also reflect underlying disease, selection into the study, treatment delivery, and follow-up. The registry records one group and no masking. It does not describe a randomized comparison, so an LPFS estimate, if reported, would be descriptive of the observed group rather than a randomized contrast.
How should planning illustrations be read?
General sample-size planning asks how much information a future study may need to detect a specified effect under stated assumptions. The planning illustration associated with this study uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; its target effect is expressed as a stated fraction of the observed effect. For time-to-event planning, the illustration concerns a total number of events, while other planning outcomes are expressed as participants per arm. These are planning assumptions, not the trial's own design description. The actual study is single-group, and the registry record does not report the numerical effect or planning results needed to assess those illustrations. Planning values are not observed power and do not describe what the completed trial demonstrated.
The record says only sponsor-reported hazard ratios are used for time-to-event interpretation, but it does not report a hazard ratio in the registry record for this account. A hazard ratio is generally a relative comparison of event rates over time between groups; its interpretation requires a suitable comparison and assumptions about the relationship between those rates. A single-group study does not supply a concurrent randomized contrast. No hazard ratio or analysis result should therefore be inferred from the endpoint label alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple outcomes in addition to LPFS: objective response rate after neoadjuvant chemotherapy and after surgery following chemotherapy and SBRT, overall survival, time to progression, FACT-G, margin-negative resection after neoadjuvant therapy, and acute and late toxicities associated with SBRT. It records 10 outcome measures. Looking at multiple outcomes can raise multiplicity concerns because, in general, making many statistical tests increases the chance that at least one result appears noteworthy by chance. Whether and how that concern was addressed depends on a prespecified statistical plan.
A multiplicity adjustment, hierarchy among outcomes, or distinction between confirmatory and exploratory analyses is not reported in the registry record. The record also gives zero analyses, so it does not provide analysis-level estimates or tests for these outcomes. The presence of several registered outcomes alone does not show that every outcome was analyzed or that any particular method was used to control multiplicity.
Missing-data handling and analysis populations are also not described in sufficient detail. The primary endpoint names an evaluable-for-response population, but the number of participants in it, reasons for exclusion, and handling of incomplete follow-up are not reported in the registry record. The record does not state whether analyses used an intention-to-treat principle, a per-protocol population, or another approach. For time-to-event outcomes, the censoring rules are not reported. These omissions limit assessment of who contributed to each result and how incomplete observation may affect interpretation.
These are reporting gaps, not evidence that a particular method was or was not used in practice. Without the statistical analysis plan and analysis results in the registry record, multiplicity control, missing-data assumptions, and population definitions beyond the stated primary population cannot be evaluated.
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 |
|---|---|---|---|
| Gem + Xeloda + SBRT | 6 | 34 | 17.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Gem + Xeloda + SBRT | 30 of 34 |
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 |
|---|---|
| Gem + Xeloda + SBRT | 28 of 34 |
Most frequent serious adverse event terms
| Event term | Organ system | Gem + Xeloda + SBRT |
|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 2 of 34 |
| White blood cell decreased ( leukopenia) | Investigations | 2 of 34 |
| Abdominal Infection | Infections and infestations | 1 of 34 |
| Ileus | Gastrointestinal disorders | 1 of 34 |
| Bleeding | Injury, poisoning and procedural complications | 1 of 34 |
| Stroke | Nervous system disorders | 1 of 34 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Gem + Xeloda + SBRT |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | 7 of 34 |
| Neutropenia | Blood and lymphatic system disorders | 6 of 34 |
| White blood cell decreased ( leukopenia) | Investigations | 5 of 34 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 5 of 34 |
| Diarrhea | Gastrointestinal disorders | 5 of 34 |
| Liver Dysfunction | Hepatobiliary disorders | 4 of 34 |
| Hand-Foot | Infections and infestations | 3 of 34 |
| Edema | General disorders | 1 of 34 |
| Dermatitis | Injury, poisoning and procedural complications | 1 of 34 |
| Mucositis | General disorders | 1 of 34 |
Serious events with the highest arm-level rate: neutropenia (5.9%), white blood cell decreased ( leukopenia) (5.9%), abdominal infection (2.9%), ileus (2.9%), bleeding (2.9%).
The registry's single treatment group is labeled Gem + Xeloda + SBRT. It records 6 participants with serious adverse events among 34 at risk and 28 with other adverse events among 34 at risk. The record also lists 30 deaths. These figures are descriptive entries; they do not establish that the events or deaths were caused by treatment. The registry information does not specify the relationship assessment, event timing, overlap between categories, or the follow-up period associated with these counts.
The serious-event terms with reported percentages are neutropenia, 5.9%; white blood cell decreased (leukopenia), 5.9%; abdominal infection, 2.9%; ileus, 2.9%; bleeding, 2.9%; and stroke, 2.9%. These percentages are registry entries and should not be treated as comparative risks. The record does not provide a control group for judging whether event frequency differs from another strategy, and these terms do not represent a complete clinical interpretation of the safety profile.
Counts and percentages can use different denominators or refer to different event summaries. The registry does not explain further how the listed terms relate to the overall affected-participant counts. The figures should therefore be read as the record reports them, without adding them together or inferring that categories are mutually exclusive. Adverse-event reporting also does not establish treatment effectiveness.
12. What the Result Does, and Does Not, Mean
The study addresses a defined statistical question: the time from enrollment to documented local progression under the registry's LPFS event definition after induction gemcitabine/capecitabine followed by SBRT. Its single-group phase 2 design can describe outcomes in the enrolled treatment group. The registry reports an enrollment of 35 and specifies a median and 95% confidence interval as the planned primary summaries.
The numerical primary result is not reported in the registry record. This means the endpoint's observed magnitude and precision cannot be assessed from the available record. The study's completion status and the existence of a named endpoint do not substitute for its estimate. Nor can any missing result be reconstructed from the design description, listed outcomes, or adverse-event entries.
Even if an LPFS estimate were available, the single-group design would not establish how outcomes compare with another treatment. General differences between groups studied at different times or in different settings can reflect participant selection, disease characteristics, follow-up, and measurement as well as treatment. A randomized comparator is not listed, and the record does not report an adjusted comparative analysis.
The endpoint also has a bounded meaning. Per the registry definition, distant disease and death do not count as LPFS events, while local target-lesion progression does. Other registered outcomes address overall survival, time to progression, response, resection, quality of life, and toxicity, but their results are not reported in the registry record for this account. LPFS should not be used as a substitute for those outcomes.
In short, the record describes the study question, regimen, endpoint, and some safety data, but does not provide the primary numerical result or comparative evidence. It cannot establish from these registry entries whether the regimen changes outcomes, or quantify how much benefit or harm it might have relative to an alternative.
13. Why This Trial Matters Statistically
This trial illustrates why the estimand—the specific outcome a study intends to describe—must be read together with the event definition and analysis population. LPFS is not a generic measure of all progression: the registry defines a local target-lesion event and excludes distant disease and death. A different endpoint definition could yield a different time-to-event summary, even for the same participants. Clear definitions are essential for interpreting and comparing results.
The record also shows the distinction between a registered outcome and a reported result. Naming a median and confidence interval identifies how LPFS is intended to be summarized, but without the values readers cannot assess either the outcome's magnitude or its precision. Completion status and an enrollment figure do not answer that statistical question.
Design is equally important. A single-group study can provide descriptive evidence about outcomes observed after a treatment sequence, but does not by itself identify a comparative treatment effect. The registry's additional outcomes do not change that design. This distinction helps prevent within-group outcome descriptions from being mistaken for causal comparisons.
Finally, safety counts require their own context: denominators, event definitions, timing, and attribution. The record contains serious-event and other-event counts, but does not detail all of those features. Reporting the counts accurately while avoiding causal interpretation is part of sound statistical reading. These considerations apply broadly to clinical trial registries, especially when outcome estimates and analysis details are sparse.
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.
Several limitations are specific to the information recorded for this study. The primary LPFS estimate and its 95% confidence interval are not reported in the registry record, so the principal outcome's magnitude and precision cannot be evaluated. Although the primary population is described as patients able to be evaluated for response after study treatment, the number in that population is not given.
The single-group design has no concurrent control group, so it cannot support a direct randomized comparison. Allocation is recorded as NA and masking as none. The record does not give detailed eligibility criteria, treatment doses or schedules, numbers receiving each component, or follow-up and censoring procedures. These omissions make it harder to assess the population and implementation behind any outcome.
The endpoint is narrowly defined around local progression in the target lesion; death and distant disease are not events for LPFS. This is a feature of the endpoint definition, but it limits what the measure represents. The registry lists other clinically relevant outcomes, yet their numerical results are not reported in the registry record for this account. It also records zero analyses, and gives no multiplicity strategy, missing-data procedures, or detailed analysis-population definitions.
Safety reporting includes counts and selected serious-event terms, but the record does not state event attribution, timing, overlap, or full denominator context for the listed terms. These data do not permit a controlled safety comparison. Together, these limitations mean the registry information supports description of the trial framework and selected recorded events, but not a complete statistical assessment of treatment outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma — NCT01360593.
- Registry record last updated 2022-03-08; status last verified 2022-02.
- Results first posted 2022-03-08.
- 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
NCT01360593 is a completed phase 2, single-group study of induction gemcitabine and capecitabine followed by SBRT in locally advanced pancreatic adenocarcinoma. The registry records an enrollment of 35, no masking, and allocation as NA. The primary outcome is median local progression-free survival, with a 95% confidence interval and a timeframe of up to 32 months. Its event definition concerns documented local progression in the target lesion and excludes death and distant disease.
The registry does not report the primary estimate or interval, and records zero analyses. Additional registered outcomes include response, overall survival, time to progression, FACT-G, resection, and toxicities. Safety entries include serious-event counts, other-event counts, selected serious-event terms, and deaths, without a control group. These registry entries describe the study record but do not establish comparative treatment effects.