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 Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers (NCT00848783), a randomized phase 2 study. The primary outcome is Number of Patients With One-year Recurrence-free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00848783 |
| Phase | Phase 2 |
| Condition | Gastric Cancer, Gastric Adenocarcinoma, Esophageal Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | 2 |
| Lead sponsor | NYU Langone Health |
| Results posted | Yes |
2. Clinical Question
The trial asked whether adding postoperative intraperitoneal floxuridine to a treatment sequence involving induction irinotecan and cisplatin, potentially curative surgery, and subsequent capecitabine could affect one-year recurrence-free survival in patients with locally advanced gastric or gastro-esophageal adenocarcinoma. It was a randomized phase II study with two parallel treatment groups.
Population
Patients with locally advanced gastric or gastro-esophageal adenocarcinoma. The registry lists gastric cancer, gastric adenocarcinoma, and esophageal cancer among the conditions. The primary outcome is described as based on the intent-to-treat population. Detailed eligibility criteria are not reported in the registry record.
Intervention
Induction treatment with intravenous cisplatin and irinotecan, followed by re-evaluation and surgery for patients with complete response, partial response, or stable disease. The intervention group then received postoperative intraperitoneal floxuridine. The official title also describes prolonged administration of capecitabine.
Comparator
The comparator followed the same induction and re-evaluation approach, with potentially curative surgery when specified, but without postoperative intraperitoneal floxuridine. The arm description says the comparator was the same as the floxuridine arm except for the absence of postoperative IP treatment.
Primary question
How many patients in each group were recurrence-free at 1 year after the start of induction chemotherapy? The registry lists 3 participants in the floxuridine group and 2 in the group without floxuridine. These are arm-level counts, not a reported estimate of the between-group treatment effect.
The question is specifically about recurrence-free status at a fixed time, not about the timing of recurrence throughout follow-up. The registry also lists overall survival rate, toxicity, and evaluation of sites of relapse among secondary outcomes. It does not report a comparative analysis for the primary question.
3. Trial Design
This was a randomized, open-label, parallel-group phase II study sponsored by NYU Langone Health. The registry lists enrollment as 8 and status as terminated. The recorded study start is 2008-05, and primary completion is recorded as 2011-08. The reason for termination is not reported in the registry record.
The treatment sequence began with induction cisplatin and irinotecan. The arm description specifies cisplatin 25 mg/m^2 and irinotecan 75 mg/m^2 once a week for 4 weeks, followed by two weeks without treatment, then one repeat of the course. Patients were re-evaluated after induction. The description specifies surgery for complete response, partial response, or stable disease, and leaving the protocol for progression. Whether every participant reached surgery or the postoperative phase is not reported in the registry record.
The randomized contrast concerned postoperative intraperitoneal floxuridine. One group received it, while the other followed the same described approach without that postoperative treatment. The official title describes prolonged capecitabine after surgery, but the arm descriptions do not give its schedule or detail how it was administered. Those details are not reported in the registry record.
Masking is listed as none, so the study was not recorded as masked. The record does not report the randomization procedure, allocation ratio, concealment approach, eligibility criteria, or intended number of participants beyond the enrollment entry. It also does not explain why the trial was terminated. The posted primary endpoint counts are 4 for the floxuridine group and 3 for the group without floxuridine, while the registry enrollment entry is 8; an explanation for the difference is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Patients were randomized to Arm A or Arm B after the response evaluation of the induction treatment. One patient was not randomized due to progression of disease before surgery and was taken off the protocol treatment.
Overall Study
| Stage | A-with IP Floxuridine | B-Without IP Floxuridine | Induction Treartment Only |
|---|---|---|---|
| STARTED | 4 | 3 | 1 |
| COMPLETED | 1 | 1 | 1 |
| NOT COMPLETED | 3 | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: Based on intent-to-treat population.
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 | A-with IP Floxuridine | B-Without IP Floxuridine | Induction Treatment Only | Total |
|---|---|---|---|---|---|
| Participants analysed | 4 | 3 | 1 | 8 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 4 | 3 | 1 | 8 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Age, Continuous | years | 53.8 (SD 12.8) | 54.3 (SD 3.2) | 60 (SD 0) | 54.8 (SD 8.8) |
| Sex: Female, Male: Female | Participants | 1 | 0 | 0 | 1 |
| Sex: Female, Male: Male | Participants | 3 | 3 | 1 | 7 |
| Region of Enrollment: United States | participants | 4 | 3 | 1 | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Patients With One-year Recurrence-free Survival, measured over 1 year.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of patients with one-year recurrence-free survival. The registry defines this as patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy. It is therefore a fixed-time binary outcome: each patient is either recorded as recurrence-free at that time or is not. The endpoint is expressed as a count of participants rather than as a continuous measurement or a time-to-event estimate.
A fixed-time recurrence-free outcome can provide a clinically interpretable snapshot of disease recurrence after treatment begins. It is different from reporting the full time until recurrence: the registry outcome does not, by itself, describe when an event occurred before the one-year assessment, how long patients were followed beyond that point, or the pattern of recurrence over time. The registry does not report a time-to-event analysis for this primary endpoint.
The record identifies the intent-to-treat population as the basis for the outcome. It lists 3 participants with the outcome in the group assigned intraperitoneal floxuridine and 2 in the group without it. The corresponding listed arm counts are 4 and 3. The registry does not explain whether any enrolled participant lacked an outcome assessment or how missing outcome information was handled.
Using a participant count makes the result easy to read, but a count alone does not quantify the precision of a comparison. The registry record does not report a confidence interval, p-value, or treatment-effect estimate for this endpoint. Consequently, the posted counts describe the observed records but do not establish how uncertain the difference between groups is.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports 3 participants with one-year recurrence-free survival in the group assigned postoperative intraperitoneal floxuridine and 2 in the group without it. The listed arm counts are 4 and 3, respectively. These figures describe the posted primary outcome counts. They are not accompanied by a comparative estimate, confidence interval, or p-value, so the registry does not quantify the size or precision of a between-group effect.
The counts are small, which limits how much can be learned from a simple contrast between arms. With small groups, a single participant’s outcome can substantially affect the observed pattern. This is a general statistical consideration, not a calculated estimate of the effect in this trial. The posted record does not provide enough information to determine how stable the observed counts would be under different samples or to separate treatment effects from random variation.
The record identifies the outcome population as intent-to-treat, but does not give an account of missing endpoint data or explain how the listed outcome counts relate to the registry enrollment entry. The enrollment entry is 8; the primary outcome lists arm counts of 4 and 3. This discrepancy in the record’s displayed counts should be kept in mind, without assuming why it occurred. The reason is not reported in the registry record.
There are no posted analyses for the primary comparison: the registry records 0 analyses. A recalculated unadjusted comparison is also not reported as an estimable result. In the absence of an analysis, it would be inappropriate to treat the raw counts as evidence of a reliable treatment advantage or disadvantage. The result is descriptive rather than a statistically resolved comparison.
The study’s randomized design establishes the intended basis for comparing the treatment strategies, but randomization alone does not overcome limitations from a small enrolled sample, incomplete or unexplained outcome reporting, or the absence of a reported analysis. Nor does a primary endpoint count address the secondary outcomes of overall survival, toxicity, and relapse sites. Those outcomes require their own results and analyses, which are not fully reported in the registry record.
The sponsor’s own analysis takes precedence when available, but a sponsor analysis is not reported for this primary outcome in the registry record. No conclusion about whether either treatment strategy changes recurrence risk can be drawn from these counts alone. They show what the registry recorded for the endpoint and the limited precision of the available evidence, not a definitive estimate of treatment effect.
9. Statistical Methods Explained
The statistical information in the registry is limited. It identifies a randomized, parallel-group study and gives a binary primary outcome as participant counts. The record does not report a statistical analysis plan, a model for the primary comparison, or a sponsor-reported treatment-effect estimate. There are 0 analyses recorded for the outcome. This means the posted result should be read descriptively rather than as a completed inferential comparison.
What does a count show?
A count tells how many participants were recorded with the specified outcome in an arm. Here, the outcome is being recurrence-free at 1 year since the start of induction chemotherapy. The counts are 3 in the group assigned intraperitoneal floxuridine and 2 in the group without it. The corresponding arm counts are 4 and 3. Counts alone do not express uncertainty in a comparison, and they do not show how the result might vary across repeated studies.
For a binary endpoint, an analysis commonly estimates an arm-level event probability and then compares those probabilities using a chosen measure of effect. The registry does not post such an estimate for this endpoint. The relevant statistical method, adjustment choices, and handling of any missing values are not reported in the registry record. No new estimate can be inferred from the record’s counts without performing a separate calculation, and the posted record does not present one.
Why is uncertainty important?
A confidence interval is a range of values compatible with the observed data under a specified statistical model and its assumptions. It communicates precision as well as direction and magnitude. A narrow interval generally indicates more precision than a wide one; an interval spanning effects in different directions can indicate that the data do not clearly distinguish among those possibilities. These are general explanations. The registry does not report a confidence interval for the primary comparison, so its width and the range of plausible effects cannot be assessed from the posted result.
A p-value, when calculated under a specified null hypothesis and analysis method, describes how unusual data at least as extreme as those observed would be if that hypothesis and model were true. It is not the probability that the null hypothesis is true, nor is it a measure of clinical importance. No p-value is reported for this comparison. Because the statistical test and its assumptions are also not reported, there is no basis for interpreting statistical significance from the posted counts.
What does the planning illustration represent?
The registry’s stated sample-size assumptions describe a planning illustration based on the observed effect, not the study’s original design. The assumptions specify a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For non-time-to-event outcomes, the planning quantity is participants per arm for 80% power or participants per arm for 90% power. These quantities are planning illustrations, not observed power and not evidence that the study was adequately powered. The registry does not report the original sample-size justification or a protocol-based target.
Observed power is not a useful substitute for uncertainty intervals: when based on an observed effect, it largely recasts the observed result and does not resolve the uncertainty in the estimate. The planning assumptions also depend on the observed effect, which is especially unstable when counts are small. No sample-size calculation should be interpreted as a result of the trial or as an explanation for its enrollment.
Why can small counts affect an analysis?
With sparse binary data, standard large-sample approximations can be unreliable. Some methods may return unstable estimates or intervals, and some may fail when event patterns are sparse. Exact or other small-sample approaches can sometimes be considered, but the method depends on the estimand and analysis plan. The registry does not report which method was planned or used, and no method should be attributed to the trial without that information.
These general considerations do not replace the sponsor’s analysis. The registry record does not contain a sponsor-reported analysis for the primary comparison. If a sponsor analysis were available, that analysis would take precedence over an unadjusted recalculation from summary counts. In this record, the counts are best treated as a limited descriptive account, with the inferential questions left unresolved.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| A-with IP Floxuridine | 4 | 3 | 75.0% | 19.4% to 99.4% | 30.1% to 95.4% | 28.4% to 94.7% |
| B-Without IP Floxuridine | 3 | 2 | 66.7% | 9.4% to 99.2% | 20.8% to 93.9% | 19.4% to 93.2% |
R code and output
arm <- c("A-with IP Floxuridine", "B-Without IP Floxuridine")
n <- c(4, 3)
events <- c(3, 2)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM A-with IP Floxuridine 4 3 75.0 19.4 99.4 30.1 95.4 28.4 94.7
ARM B-Without IP Floxuridine 3 2 66.7 9.4 99.2 20.8 93.9 19.4 93.211. Multiplicity, Missing Data and Analysis Populations
The registry identifies one primary endpoint and lists secondary outcomes of overall survival rate, toxicity, and evaluation of sites of relapse among failing patients. It reports 2 outcome measures but records 0 analyses. No multiplicity adjustment, testing hierarchy, or strategy for interpreting several outcomes is reported in the registry record. Without such information, it is not possible to determine whether any planned control of false-positive findings across outcomes was intended or applied.
The primary endpoint is described as based on the intent-to-treat population. This identifies the intended analysis population in broad terms, but the registry does not explain how participants with missing endpoint status, protocol deviations, or unavailable follow-up were handled. It also does not report the number of missing primary outcome assessments or reasons for any missingness. The primary outcome arm counts are 4 and 3, while the registry enrollment entry is 8; the record does not account for the difference.
The registry does not describe imputation, sensitivity analyses, censoring rules, or other missing-data procedures for this endpoint. It also does not provide details of an analysis population beyond the intent-to-treat description. These omissions make it difficult to assess whether the posted counts represent all randomized participants or how any unobserved outcomes might affect interpretation.
Because no comparative analysis is recorded, there are no reported adjusted or unadjusted results to reconcile across endpoints. Results for secondary outcomes should not be inferred from their listing as planned or recorded outcomes. Their numerical findings and statistical methods are not reported in the registry record.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| A-with IP Floxuridine | 0 | 4 | 0.0% |
| B-Without IP Floxuridine | 2 | 3 | 66.7% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| A-with IP Floxuridine | 4 of 4 |
| B-Without IP Floxuridine | 3 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | A-with IP Floxuridine | B-Without IP Floxuridine |
|---|---|---|---|
| Neutrophils/Granulocytes (Anc/Agc) | Blood and lymphatic system disorders | 0 of 4 | 1 of 3 |
| Infection With Normal Anc Or Grade 1 Or 2 Neutrophils | Infections and infestations | 0 of 4 | 1 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | A-with IP Floxuridine | B-Without IP Floxuridine |
|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | 4 of 4 | 2 of 3 |
| Hemoglobin | Blood and lymphatic system disorders | 4 of 4 | 1 of 3 |
| Fatigue (Asthenia, Lethargy, Malaise) | General disorders | 4 of 4 | 1 of 3 |
| Nausea | General disorders | 4 of 4 | 1 of 3 |
| Vomiting | Gastrointestinal disorders | 3 of 4 | 1 of 3 |
| Neutrophils/Granulocytes (Anc/Agc) | Blood and lymphatic system disorders | 3 of 4 | 1 of 3 |
| Anorexia | Gastrointestinal disorders | 2 of 4 | 1 of 3 |
| Pain | General disorders | 3 of 4 | 0 of 3 |
| Insomnia | General disorders | 2 of 4 | 0 of 3 |
| Weight Loss | General disorders | 2 of 4 | 0 of 3 |
Serious events with the highest arm-level rate: neutrophils/granulocytes (anc/agc) (33.3%), infection with normal anc or grade 1 or 2 neutrophils (33.3%).
The adverse-event record lists serious events by treatment group. In the group assigned intraperitoneal floxuridine, 0 serious events are listed among 4 at risk. In the group without intraperitoneal floxuridine, 2 serious events are listed among 3 at risk. The entries describe reported event counts, not necessarily the number of participants with at least one event unless the registry defines them that way. A definition of the counting unit is not reported in the registry record.
The record also lists other adverse events affecting 4 among 4 at risk in the floxuridine group and 3 among 3 at risk in the group without it. These are separate registry entries from the serious-event counts and should not be combined with them. The death fields have no reported value. The registry lists neutrophils/granulocytes (Anc/Agc) and infection with normal Anc or grade 1 or 2 neutrophils as serious terms, each with a reported frequency of 33.3%. The denominator and precise basis for those term frequencies are not reported in the registry record.
Small group counts make safety comparisons imprecise, and the registry does not report a comparative safety analysis or confidence intervals. The adverse-event entries describe what is recorded; they do not establish that an event was caused by a treatment. The record also does not provide enough detail to interpret event timing, duration, recurrence, or clinical severity beyond the serious-event classification.
13. What the Result Does, and Does Not, Mean
The posted primary endpoint result is a set of small arm-level counts: 3 participants with one-year recurrence-free survival in the group assigned postoperative intraperitoneal floxuridine and 2 in the group without it. The associated arm counts are 4 and 3. These figures convey the recorded outcome, but do not provide a precise estimate of how the treatment strategies compare.
The registry does not report a confidence interval, p-value, or sponsor analysis for the primary comparison. It also does not explain how the primary outcome counts relate to the enrollment entry of 8. As a result, the apparent difference in raw counts cannot be interpreted as evidence that adding floxuridine improves or worsens recurrence-free survival. No treatment recommendation follows from these data.
The trial’s intended comparison was randomized and focused on postoperative intraperitoneal floxuridine within a broader treatment sequence. The posted result cannot isolate effects of every component of that sequence, nor does the primary endpoint address the secondary outcomes of overall survival, toxicity, and relapse sites. Numerical findings for those outcomes are not reported in the registry record in a form that supports interpretation.
The result also does not answer how long patients remained recurrence-free, what happened after the one-year assessment, or how recurrence patterns differed over follow-up. The endpoint is a fixed-time status recorded at 1 year from induction start. A time-to-event analysis and additional follow-up results are not reported in the registry record.
In short, the record documents an intended randomized comparison and a limited set of outcome and safety counts. It does not provide the inferential results needed to assess the size, precision, or reliability of a treatment effect. The appropriate reading is descriptive and cautious, with the unexplained outcome accounting and absent analysis central to interpretation.
14. Why This Trial Matters Statistically
This trial raises a clear statistical question: what can be learned from a randomized comparison when the posted outcome counts are small and the registry does not report a comparative analysis? The contrast was designed around adding postoperative intraperitoneal floxuridine to an induction-and-surgery strategy, making the primary endpoint directly relevant to the stated treatment question.
At the same time, the posted counts illustrate why an endpoint result needs more than an event count for interpretation. Without an effect estimate and uncertainty interval, readers cannot judge the plausible range of differences between groups. Sparse data can also make standard approximations less dependable, a general issue that emphasizes the importance of a stated analysis method and transparent reporting.
The record is also a useful reminder to distinguish a randomized design from a fully reported statistical result. Random allocation is the intended basis for a fair comparison, but it does not supply missing outcome accounting, analysis details, or precision estimates. Here, the registry enrollment entry is 8, whereas the outcome arm counts are 4 and 3; the explanation is not reported. That gap limits assessment of the analysis population and completeness.
Finally, the record lists secondary outcomes and safety information, but does not provide a full inferential account across them. Clear reporting of outcome definitions, missing-data handling, methods, and uncertainty would be needed to understand how much the results support the clinical question. The trial therefore matters statistically as an example of why transparent methods and complete reporting are essential alongside randomization.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation is the small amount of posted primary outcome information. The endpoint lists counts of 3 and 2, with arm counts of 4 and 3, and no comparative analysis. The registry enrollment entry is 8, but it does not explain how that entry relates to the endpoint counts. It is not possible to determine from the record whether the difference reflects missing outcomes, a change in the analyzed population, or another reason.
The registry records the study as terminated but does not report the reason. It does not report the original sample-size justification, target enrollment, or whether recruitment and follow-up proceeded as intended. The planning assumptions described in the record are illustrative and based on the observed effect; they do not establish the design rationale or the study’s ability to detect a clinically important effect.
The record specifies an intent-to-treat basis for the primary outcome but does not report a missing-data approach, analysis model, confidence interval, or p-value. Details of randomization and allocation concealment are also not reported. Masking is listed as none, but the consequences of open-label conduct for outcome assessment are not discussed in the registry record.
The arm descriptions do not give a detailed schedule for capecitabine, and do not explain which participants proceeded through surgery or postoperative treatment. The primary outcome is fixed at 1 year from induction start; further information about follow-up and recurrence timing is not reported. These limitations restrict both the statistical interpretation and the ability to understand treatment exposure from the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers — NCT00848783.
- Registry record last updated 2018-01-08; status last verified 2017-12.
- Results first posted 2012-12-10.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
This registry record describes a randomized, open-label, parallel-group phase II study sponsored by NYU Langone Health. It compares a treatment sequence including induction irinotecan and cisplatin, re-evaluation, potentially curative surgery, and postoperative intraperitoneal floxuridine with the same described approach without postoperative floxuridine. The official title also refers to prolonged capecitabine.
The primary endpoint is the number of participants with one-year recurrence-free survival, defined from the start of induction chemotherapy. The registry lists 3 such participants in the floxuridine group and 2 in the group without floxuridine; the corresponding arm counts are 4 and 3. Enrollment is listed as 8, and the record does not explain the difference between enrollment and endpoint counts.
The study status is terminated, with no reason reported. No analysis is recorded for the primary comparison, and no confidence interval or p-value is reported. Secondary outcomes include overall survival rate, toxicity, and evaluation of relapse sites. The available results support a descriptive account, but not a precise estimate of the comparative treatment effect.