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 Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis (NCT04034251), a non-randomized phase 2 study. The primary outcome is Progression Free Survival (PFS) in Participants With Peritoneal Metastases From Gastric Cancer After Repeated Intraperitoneal Chemotherapeutic Infusion (IPC) and Systemic Paclitaxel Administration With Concomitant Capecitabine Therapy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04034251 |
| Phase | Phase 2 |
| Condition | Gastric Adenocarcinoma, Gastric Cancer, Esophagogastric Junction |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Adults with gastric cancer that has spread throughout the abdomen were the intended population. The registry describes gastric adenocarcinoma with peritoneal carcinomatosis and states that participants were to be ages 18 and older. The primary outcome description notes that 4/5 participants are analyzed in the first group because one participant was deemed ineligible.
Intervention
The study examined paclitaxel delivered both into the peritoneal cavity and intravenously, together with oral capecitabine. The registry lists dose descriptions that include intraperitoneal paclitaxel 20mg or 60mg, intravenous paclitaxel 80mg every 3 weeks, and capecitabine 825mg/m^2 twice daily. It also lists a general description without specified paclitaxel doses.
Comparator
The registry categorizes the study as non-randomized and single-group. It is therefore not described as a randomized comparison against a separate control treatment. Although dose descriptions are listed, the record does not establish a like-for-like control comparison between them.
Primary question
The primary question concerns the median progression-free survival after the combined treatment approach. Progression was defined using RECIST version 1.1 together with specified indicators of peritoneal disease progression. The registry record does not report the observed median or full range.
3. Trial Design
NCT04034251 is registered as a phase II, non-randomized, unmasked, single-group study. The registry lists enrollment of 12 and a status of terminated. The recorded start date is 2020-06-09, and the primary completion date is 2023-02-25. The reason for termination is not reported in the registry record.
The study concerns gastric adenocarcinoma with peritoneal carcinomatosis. Its treatment description combines paclitaxel administered by intraperitoneal and intravenous routes with oral capecitabine. The registry lists two specific paclitaxel dose descriptions: intraperitoneal 20mg with intravenous 80mg every 3 weeks, and intraperitoneal 60mg with intravenous 80mg every 3 weeks. Both include capecitabine 825mg/m^2 twice daily. A third intervention description gives the routes and schedule without specifying the paclitaxel doses.
The registry’s brief description says paclitaxel would be given every 3 weeks and capecitabine twice daily during the first 15 days of a 21-day cycle. It describes scans after 3 cycles and says another course of therapy may be given. These details describe the planned treatment and follow-up; they do not establish how many participants completed treatment or received further therapy.
Screening procedures in the description include medical history, examination, laboratory and heart tests, scans, tissue assessment, performance and dietary assessments, and laparoscopy. The description says a peritoneal port and catheter would be placed during the first laparoscopy and that further laparoscopies could monitor disease. Whether every listed procedure was completed by each participant is not reported in the registry record.
Because the study is non-randomized and categorized as single-group, the dose descriptions should not be read as randomized treatment arms or as evidence of a controlled comparison. The record does not report the allocation process, a protocol-specific sample-size justification, or a detailed statistical plan.
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 | Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily |
|---|---|---|---|
| STARTED | 5 | 7 | 0 |
| COMPLETED | 4 | 7 | 0 |
| NOT COMPLETED | 1 | 0 | 0 |
Reasons for not completing this period:
| Reason | Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily |
|---|---|---|---|
| Screen failure due to development of solid organ mets in lung; no longer met eligibility criteria. | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: 4/5 participants are analyzed in the first group because one participant was deemed ineligible.
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: Collected baseline data are reported for one participant in the first group who was later deemed ineligible.
| Characteristic | Unit | Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | Total |
|---|---|---|---|---|
| Participants analysed | 5 | 7 | 12 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 | 7 | 12 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 48.28 (SD 9.79) | 50.39 (SD 7.98) | 49.51 (SD 8.41) |
| Sex: Female, Male: Female | Participants | 3 | 2 | 5 |
| Sex: Female, Male: Male | Participants | 2 | 5 | 7 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 | 6 | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 3 | 6 | 9 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 |
| Region of Enrollment: United States | participants | 5 | 7 | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Progression Free Survival (PFS) in Participants With Peritoneal Metastases From Gastric Cancer After Repeated Intraperitoneal Chemotherapeutic Infusion (IPC) and Systemic Paclitaxel Administration With Concomitant Capecitabine Therapy, measured over From the first treatment to progression of disease, up to 2 years and 1 month.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is progression-free survival, reported as a median in months with a full range. It is defined as the time from first treatment until progression of disease, within a stated observation window of up to 2 years and 1 month. Progression was assessed using RECIST version 1.1 and the additional criteria described in the registry.
The registry’s progression definition includes an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI; new ascites requiring repeat (more than 1) therapeutic paracentesis; malignant bowel obstruction; new intraperitoneal nodules or masses concerning for peritoneal metastasis; and decline in performance status not attributable to other medical causes. These criteria make the endpoint specific to the disease setting and the study’s assessment approach.
In general, progression-free survival captures how long participants remain alive without a defined progression event. A median is a summary of the time-to-event distribution, while a full range describes the spread between the smallest and largest reported times. These summaries do not, by themselves, describe the shape of the full survival curve or the precision of the median.
The record identifies the endpoint and its measurement but does not report the observed median, full range, confidence interval, or participant-level event information. The posted results therefore do not permit a numerical interpretation of the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies progression-free survival as the primary outcome, but it does not report an observed primary outcome value. There is no posted median or full range to interpret, and no numerical estimate of how long participants remained free of defined progression. The endpoint description is detailed, but a definition is not an outcome result.
The record lists secondary outcomes that include overall survival, adverse events related to research interventions, intra-peritoneal progression-free survival (iPFS) with 80% and 95% confidence intervals, histopathologic response, extra-peritoneal disease-free survival, and the number of participants with iPFS. The record does not report numerical results for these outcomes. A listed outcome should not be mistaken for a reported finding.
The registry categorizes the trial as non-randomized and single-group. As a general statistical point, observations from a single-group study can describe outcomes among participants who were assessed, but they do not by themselves estimate what would have happened to comparable participants receiving a different treatment. The registry also lists different dose descriptions, but does not establish a randomized, controlled, like-for-like comparison between them. Differences between descriptive groups would therefore not support a causal treatment contrast.
The primary outcome description states that 4/5 participants are analyzed in the first group because one participant was deemed ineligible. This is an analysis-population detail, not an outcome estimate. The record does not explain the eligibility decision further or report corresponding outcome counts and follow-up for that analysis population.
The registry status is terminated. That status indicates that the study did not continue as originally registered, but the record does not state why it was terminated or how termination affected follow-up and outcome ascertainment. It should not be taken as evidence for or against an effect of the treatment.
The most defensible interpretation is therefore limited: the record describes the study design, treatment approach, endpoint definitions, and some safety counts, but it does not provide the primary efficacy estimate or numerical results for the listed secondary outcomes. Any claim about the magnitude, precision, or comparative effect of treatment would go beyond the posted results.
9. Statistical Methods Explained
Time-to-event outcomes describe the time until a defined event occurs. In this study, the primary event is progression of disease, and the endpoint is progression-free survival. A participant who has not had a recorded progression event by the end of observed follow-up may have incomplete event-time information; standard time-to-event methods can account for such censoring when the analysis and data support doing so. The registry record does not report the event count, censoring information, or a detailed analysis method for the primary endpoint.
What does a median time-to-event measure?
In general, the median time-to-event is the time at which the estimated proportion remaining event-free reaches the midpoint of the population represented by the analysis. It is a distributional summary, not a guarantee that every participant has that outcome time. The full range, when reported, gives the minimum and maximum observed times, but can be sensitive to individual observations and does not show the pattern of events between those endpoints.
The primary outcome is described as a median with a full range, but its numerical summary is not reported in the registry record. Without the estimate and its supporting information, readers cannot assess the observed time scale, the spread of observed times, or the precision of the median. The record also does not say whether a survival curve or another time-to-event summary was used in the analysis.
How should progression definitions be read?
In general, a progression endpoint depends on an operational definition: the rules that determine when the event is considered to have occurred. The registry uses RECIST version 1.1 and also lists peritoneal disease-related criteria. These include change in PCI, ascites requiring repeat therapeutic paracentesis, bowel obstruction, new concerning intraperitoneal lesions, and performance-status decline not attributed to other medical causes. These components may capture different clinical manifestations, so applying the definition consistently is important to interpreting an event time.
The record does not report how each criterion contributed to the primary outcome, how progression assessments were adjudicated, or whether assessment timing differed among participants. Those details matter in general because event ascertainment can affect the measured time to progression. Their absence does not prove that assessments were inconsistent; it means that the record does not allow readers to evaluate these features.
What does a confidence interval contribute?
In general, a confidence interval expresses the uncertainty around an estimate under a specified statistical procedure. A narrower interval indicates greater precision under that procedure, while a wider interval indicates more uncertainty. An interval does not ensure that an estimate is free from bias, and it does not account automatically for limitations such as non-random allocation or incomplete outcome reporting.
The registry lists iPFS outcomes with 80% and 95% confidence intervals, but it does not provide the corresponding estimates or interval limits. The confidence levels alone do not show the precision of an observed result. The primary outcome is described with a median and full range; no primary confidence interval is reported in the registry record.
Why does the study design matter for interpretation?
In general, random allocation helps balance measured and unmeasured factors between treatment groups, on average. This study is listed as non-randomized and single-group, so the registry does not support interpreting the listed dose descriptions as randomized arms. Without a randomized control group, changes or outcomes observed during the study cannot be separated reliably from differences in participant characteristics, disease course, or other influences using a direct treatment comparison.
Sample-size calculations can be used as planning illustrations, but they rely on assumptions about the effect to detect, the statistical test, allocation, and outcome variability. The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It specifies that time-to-event illustrations give total events using the Schoenfeld method and other illustrations give participants per arm. These planning assumptions do not amount to an observed power calculation or to the trial’s original design justification. The numerical planning results and a protocol-specific sample-size justification are not reported in the registry record.
The record lists zero analyses. It does not report sponsor hazard-ratio results or a detailed statistical analysis plan. Thus, the available information does not permit readers to reconstruct the primary analysis, assess model assumptions, or determine how uncertainty was estimated. General statistical explanations clarify what the measures mean, but they cannot replace absent outcome estimates or methods details.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several secondary outcomes alongside the primary progression-free survival endpoint. In general, evaluating multiple outcomes creates a multiplicity issue: the more separate statistical tests or claims considered, the greater the chance that an apparently noteworthy finding may occur by chance if no adjustment or prespecified hierarchy is used. Whether and how multiplicity was handled is not reported in the registry record.
The record lists iPFS with both 80% and 95% confidence intervals, as well as overall survival, adverse events, histopathologic response, extra-peritoneal disease-free survival, and participant counts for iPFS. It does not report numerical estimates or explain how these outcomes relate to any planned testing hierarchy. The record lists zero analyses, and a detailed statistical analysis plan is not reported. It is therefore not possible to determine whether formal hypothesis tests were conducted, whether any adjustment was used, or which outcomes were intended to support confirmatory claims.
Missing outcome information also limits interpretation. The record does not report how many participants had complete follow-up for each endpoint, how missing assessments were handled, or whether any participants were censored before an event. These items are important for time-to-event outcomes because the estimate depends on event and follow-up information.
The primary outcome description identifies 4/5 participants as analyzed in the first group because one participant was deemed ineligible. This is the only explicit analysis-population detail in the record. The eligibility criteria applied to that decision, handling of the participant’s data, analysis populations for other outcomes, and treatment of any additional missing data are not reported in the registry record. No assumptions about these procedures can be made from the stated analysis count 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 |
|---|---|---|---|
| Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | 1 | 4 | 25.0% |
| Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | 1 | 7 | 14.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | 4 of 4 |
| Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | 6 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 |
|---|---|
| Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | 4 of 4 |
| Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | 7 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily |
|---|---|---|---|
| Abdominal infection | Infections and infestations | 0 of 4 | 1 of 7 |
| Abdominal pain | Gastrointestinal disorders | 1 of 4 | 0 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily |
|---|---|---|---|
| Neutrophil count decreased | Investigations | 2 of 4 | 5 of 7 |
| White blood cell decreased | Investigations | 2 of 4 | 3 of 7 |
| Abdominal pain | Gastrointestinal disorders | 1 of 4 | 2 of 7 |
| Anemia | Blood and lymphatic system disorders | 2 of 4 | 1 of 7 |
| Diarrhea | Gastrointestinal disorders | 0 of 4 | 3 of 7 |
| Peripheral sensory neuropathy | Nervous system disorders | 2 of 4 | 1 of 7 |
| Infections and infestations - Other, Covid-19 | Infections and infestations | 0 of 4 | 2 of 7 |
| Lymphocyte count decreased | Investigations | 1 of 4 | 1 of 7 |
| Nausea | Gastrointestinal disorders | 1 of 4 | 1 of 7 |
| Abdominal infection | Infections and infestations | 0 of 4 | 1 of 7 |
Serious events with the highest arm-level rate: abdominal pain (25.0%), abdominal infection (14.3%).
The registry lists related serious adverse events for two dose descriptions. For the group described as intraperitoneal paclitaxel 20mg with intravenous paclitaxel 80mg every 3 weeks and capecitabine 825mg/m^2 twice daily, 4 participants were at risk and 1 was reported with a related serious adverse event. For the group described with intraperitoneal paclitaxel 60mg, the corresponding figures are 7 at risk and 1 with a related serious adverse event.
For related non-serious adverse events, the registry reports 4 participants at risk and 4 affected in the first dose description, and 7 at risk and 7 affected in the second. These are reported counts; they do not indicate how many events each affected participant experienced or how long participants were observed.
The registry lists abdominal pain at 25.0% and abdominal infection at 14.3% among the top serious-event terms. The record does not clarify the denominator or give the full event-term listing. It also reports deaths of 4 and 6 in the respective groups, but does not state the causes, timing, or relationship of those deaths to treatment. Death counts should not be interpreted as treatment-related deaths without that information.
In general, safety counts depend on the population at risk, event definitions, duration of observation, and attribution procedures. The registry record does not provide enough detail to compare these counts as rates or to make a controlled safety contrast. The dose descriptions are not a randomized control comparison.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a phase II study of intraperitoneal and intravenous paclitaxel with oral capecitabine was registered for gastric adenocarcinoma with peritoneal carcinomatosis. It also describes the intended treatment schedule, the primary progression-free survival endpoint, the progression criteria, and selected safety counts. These registry entries explain what the study set out to assess and some of the information recorded about participants.
The record does not report the observed primary endpoint result. It therefore cannot establish the median progression-free survival, the range of observed times, or the precision of an estimate. Numerical results for the listed secondary outcomes are also not reported. The absence of these results in the registry record is not itself evidence that the treatment did or did not affect an outcome.
The study is categorized as non-randomized and single-group. In general, such a design may describe outcomes in the treated population, but it does not provide the same protection against confounding as random allocation to a concurrent control group. The listed dose descriptions do not establish a randomized comparison, and the record does not describe a valid controlled contrast between them.
The safety figures are counts reported for the listed groups. Without fuller information about event definitions, observation time, attribution, and complete safety reporting, they do not provide a complete account of risk or support comparative rate estimates. The reported death counts do not establish cause or treatment relationship.
The appropriate conclusion is narrow: the registry documents a trial design and specified outcomes, but the posted results are insufficient to quantify efficacy or draw a causal comparison. Interpretation would require reported outcome estimates, uncertainty, analysis details, and the missing follow-up and population information.
13. Why This Trial Matters Statistically
This trial is statistically important to read as a study with a clearly specified time-to-event endpoint but no numerical primary result in the registry record. A well-defined endpoint is necessary for interpretable analysis, yet it is not sufficient by itself. Readers also need the observed estimate, uncertainty, event and follow-up information, and a transparent account of who was included in the analysis.
The study also illustrates why design labels matter. The registry describes a non-randomized, single-group study while listing more than one dose description. Those descriptions do not create a randomized dose comparison. Treating them as if they were equivalent to randomized arms would overstate what the design can establish. This distinction is important when interpreting both efficacy and safety counts.
Time-to-event measures can be useful because they retain information about when an event occurs, rather than recording only whether an event was observed. But their interpretation depends on how progression is defined, how often assessments occur, and how incomplete follow-up is handled. The registry gives detailed progression criteria but does not report the observed primary outcome or those analysis details.
The record further shows the difference between a planning illustration and evidence from a completed analysis. Planning calculations depend on assumptions and are not observed treatment effects or observed power. Without the numerical results and analysis plan, a reader cannot use a planning illustration to infer what the study found.
These distinctions help prevent overinterpretation: a registered endpoint is not a result, a set of dose descriptions is not automatically a controlled comparison, and adverse-event counts are not treatment-effect estimates. In this case, the statistical record is informative about the planned question and limited in what it can answer from posted results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most consequential limitation for interpretation is that the registry record does not report the observed primary progression-free survival median or full range. It also does not provide numerical results for the listed secondary outcomes. The endpoint definition is available, but the treatment outcome cannot be quantified from the record.
The study is non-randomized and categorized as single-group. The dose descriptions should not be interpreted as randomized arms or as a controlled comparison. The record does not report allocation details, a comparator, or a protocol-specific sample-size justification. Its status is terminated, but the reason for termination is not reported in the registry record.
Some population details are limited. The primary outcome description states that 4/5 participants are analyzed in the first group because one participant was deemed ineligible. The record does not provide corresponding outcome data or explain further the eligibility decision. It does not report analysis populations for the other outcomes, follow-up completeness, censoring information, or methods for handling missing data.
Safety information is also incomplete for comparative interpretation. The registry provides selected related-event counts, top serious-event terms, and death counts, but does not report full event listings, observation duration, causes of death, or attribution details for deaths. The denominator behind the listed serious-event term percentages is not specified in the record.
Finally, the record lists zero analyses and does not provide a detailed statistical analysis plan or numerical outcome estimates. It is not possible to assess model assumptions, multiplicity handling, precision, or the robustness of any treatment-effect estimate from the posted information. These limitations describe gaps in the record and do not establish that unreported procedures or data were absent from the study itself.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis — NCT04034251.
- Registry record last updated 2026-05-05; status last verified 2026-04.
- Results first posted 2023-12-12.
- 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.
18. Record Summary
NCT04034251 is a terminated phase II study listed as non-randomized, unmasked, and single-group, with enrollment of 12. It examined intraperitoneal and intravenous paclitaxel with oral capecitabine for gastric adenocarcinoma with peritoneal carcinomatosis. The registry lists dose descriptions including intraperitoneal paclitaxel 20mg or 60mg, intravenous paclitaxel 80mg every 3 weeks, and capecitabine 825mg/m^2 twice daily.
The primary outcome is median progression-free survival in months, with full range, from first treatment until disease progression. The registry specifies progression criteria but does not report the observed median or range. Listed secondary outcomes include overall survival, adverse events, iPFS, histopathologic response, and extra-peritoneal disease-free survival; numerical results are not reported in the registry record.
The record includes selected adverse-event and death counts and states that 4/5 participants are analyzed in the first group because one participant was deemed ineligible. It does not report a detailed statistical plan, numerical outcome estimates, or the reason for termination.