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 Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial) (NCT01627288), a non-randomized na study. The primary outcome is Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01627288 |
| Phase | NA |
| Condition | Cancer of the Cervix, Cervical Neoplasms |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Duke University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with advanced, localized gynecologic cancer. The registry lists Cancer of the Cervix and Cervical Neoplasms as conditions. Its description discusses node-positive cervical cancer and tumor-bearing regions in the abdomen and pelvis; further eligibility details are not reported in the registry record.
Intervention
The intervention was integrated boost radiation delivered with an IMRT technique and concurrent chemotherapy with cisplatin. The registry describes radiation dose levels of 55 Gy, 60 Gy, 65 Gy, and 70 Gy, each assigned a schedule of 25 fractions. Dose level 0 was described as a de-escalation option if 2 dose-limiting toxicities were documented at dose level 1.
Comparator
There was no randomized comparator. The trial is listed as non-randomized and single-group, with no masking. Dose levels represent stages of dose escalation rather than randomized treatment arms intended as like-for-like controls. A between-group causal comparison is therefore not the design’s central question.
Primary question
The primary question was the maximum tolerated dose of integrated boost radiation administered with concurrent cisplatin. The registry specifies the outcome in Gray (Gy), assessed during RT to 6 weeks post RT. The numerical maximum tolerated dose and the rule used to identify it are not reported in the registry record.
3. Trial Design
The IDEAL - GYN trial was a non-randomized, single-group study with no masking. Its phase is listed as NA, its enrollment as 12, and its status as completed. The registry records a start date of 2012-06-04 and a primary completion date of 2018-11-16. Duke University is listed as sponsor.
The intervention was boost radiation administered with concurrent cisplatin. The registry describes Dose Level 1 as 2.4 Gy X 25 fractions = 60 Gy, Dose level 2 as 2.6 Gy X 25 fractions = 65 Gy, and Dose level 3 as 2.8 Gy x 25 fractions = 70 Gy. It also describes Dose level 0 as 2.2 Gy X 25 fractions = 55 Gy, with de-escalation to that level if the 2 dose limiting toxicities are documented at dose level 1. These are the dose schedules described in the record; the record does not provide a complete account of which schedule each participant received or how dose escalation proceeded in practice.
Because treatment allocation was not randomized, the dose groups should not be interpreted as equivalent groups differing only by assigned dose. Dose levels are part of a dose-finding approach, not parallel randomized controls. The registry lists outcome measures for local-regional control, distant recurrence, disease-free survival, overall survival, and acute and late dose-limiting toxicities. It lists 7 outcome measures overall, but the registry record does not report a statistical analysis for these outcomes. The number and definitions of analysis populations, eligibility details, and dose-escalation decision rules beyond the stated de-escalation condition are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Boost Radiation: Dose Level 1 | Boost Radiation: Dose Level 2 | Boost Radiation: Dose Level 3 | Boost Radiation Dose Level 0 |
|---|---|---|---|---|
| STARTED | 3 | 3 | 6 | 0 |
| COMPLETED | 3 | 3 | 6 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
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: No subjects were reduced to Boost Radiation Level 0
| Characteristic | Unit | Boost Radiation: Dose Level 1 | Boost Radiation: Dose Level 2 | Boost Radiation: Dose Level 3 | Boost Radiation Dose Level 0 | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 6 | 0 | 12 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 | 2 | 6 | 0 | 11 |
| Age, Categorical: >=65 years | Participants | 0 | 1 | 0 | 0 | 1 |
| Sex: Female, Male: Female | Participants | 3 | 3 | 6 | 0 | 12 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 | 3 | 6 | 0 | 12 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 1 | 0 | 0 | 3 |
| Race (NIH/OMB): White | Participants | 1 | 2 | 6 | 0 | 9 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 3 | 3 | 6 | — | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin)., measured over During RT to 6 weeks post RT.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Gray (Gy) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the maximum tolerated dose of integrated boost radiation administered with the IMRT technique and concurrent cisplatin. The registry expresses the outcome as a number measured in Gray (Gy), with a timeframe from during RT to 6 weeks post RT. The endpoint is intended to identify a radiation dose that can be administered within the study’s dose-finding framework while monitoring dose-limiting toxicity. That makes it distinct from an endpoint focused directly on tumor control or survival.
In general, a maximum-tolerated-dose endpoint summarizes a dose-finding decision informed by observed tolerability under a specified treatment regimen. Its interpretation depends on how dose-limiting toxicity is defined, how the observation window is applied, and how toxicity findings are translated into a selected dose. Those details, including a numerical toxicity threshold or the algorithm used to select the maximum tolerated dose, are not reported in the registry record. The primary endpoint result itself is also not reported in the registry record. The stated timeframe should therefore be read as the planned or recorded assessment window, not as evidence that a particular dose was established.
The registry also lists time to local-regional control, time to distant recurrence, disease-free survival, overall survival, and counts of participants with acute and late dose-limiting toxicities as secondary outcomes. These outcomes address different aspects of disease course and tolerability; they do not substitute for a reported primary dose-finding result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted results give dose-level counts for serious adverse events, other adverse events, and deaths. For Dose Level 1, 2 participants were affected by serious adverse events among 3 at risk; for Dose Level 2, 0 were affected among 3 at risk; and for Dose Level 3, 1 was affected among 6 at risk. The registry also reports 3 participants affected by other adverse events among 3 at risk at Dose Level 1, 3 among 3 at Dose Level 2, and 6 among 6 at Dose Level 3. These are descriptive counts within the listed dose groups, not randomized comparisons.
The record reports 1 death in each of Dose Level 1, Dose Level 2, and Dose Level 3. It does not establish from these figures whether any death was caused by treatment. The serious-event terms listed include Nausea, Vomiting, Dehydration, Hypokalemia, Urinary tract obstruction, and Rectal necrosis, with percentages recorded as 33.3% for the first five terms and 16.7% for Rectal necrosis. The registry’s figures do not supply enough context to interpret those percentages as comparative risks between treatment groups.
Most importantly, the registry does not report the numerical maximum tolerated dose, which is the stated primary outcome. Nor does it report estimates, uncertainty intervals, or statistical tests for the listed secondary outcomes. The registry lists 0 analyses. This means the record does not present inferential results that would quantify how uncertain the dose-level findings are or support formal comparisons. It does not establish that no analysis was performed outside the registry.
Counts from groups with limited numbers at risk can be highly sensitive to the outcome status of individual participants. In general, a small denominator makes a descriptive proportion unstable, and a zero count does not demonstrate that an event cannot occur. Here, the dose groups are also not randomized, so differences in counts cannot be attributed to dose alone. The available figures describe events recorded in the registry; they do not by themselves identify a tolerable dose or demonstrate a treatment effect on tumor control, recurrence, or survival.
Accordingly, interpretation should remain descriptive. The registry indicates that adverse events and deaths were recorded at each listed dose level, and it gives the corresponding group counts. It does not provide the detail needed to determine event attribution, account for differences among dose groups, or evaluate the precision of the primary dose-finding conclusion. The outcome values and analyses required for a fuller assessment are not reported in the registry record.
9. Statistical Methods Explained
What does a single-group dose-finding design tell us?
The registry classifies the trial as single-group and non-randomized. In general, a dose-finding study can assign participants to successive dose levels while monitoring tolerability, with the goal of selecting a dose for further study. That structure differs from a randomized trial in which concurrent groups are assigned to alternative treatments to estimate a comparative effect. Dose-level counts in a non-randomized escalation study are therefore primarily descriptive. They do not provide a randomized estimate of what would have happened to the same participants under a different dose.
The registry names several dose schedules and describes a condition for de-escalation to Dose level 0 if the 2 dose limiting toxicities are documented at dose level 1. It does not report the complete escalation algorithm, the toxicity grading system, the operational definition of dose-limiting toxicity, or how the final dose decision was reached. Without those details and the primary outcome value, the dose-finding conclusion cannot be reconstructed from the registry record.
How should a count endpoint be read?
The primary outcome is recorded as a number in Gray (Gy), rather than as a continuous clinical measurement with a reported average and dispersion. For this question, the number represents the selected maximum tolerated dose. Interpreting such an endpoint requires knowing the decision procedure that maps observed toxicity to a dose selection. The registry describes the outcome’s unit and timeframe, but does not report a selected value or the full decision procedure.
The safety figures are participant counts affected within groups described as at risk. A count is a direct description of how many participants were recorded with an event in a group; it does not alone convey sampling uncertainty, event severity beyond the serious-event classification, timing, or causal relationship to treatment. A confidence interval, in general, expresses the range of values compatible with data under a specified statistical model and procedure. No confidence intervals for the reported safety counts or primary outcome are reported in the registry record.
Why does randomization matter for comparisons?
Random allocation is used in general to make treatment groups comparable in expectation, helping distinguish treatment effects from differences in participant characteristics and other influences. This trial is explicitly listed as non-randomized. The listed dose groups may therefore differ in ways that are not captured by the event counts, and the registry does not provide adjustment analyses to address such differences. A numerical contrast between groups, even if calculated, would not automatically have the interpretation of a randomized treatment effect.
Masking is listed as none. In general, masking can reduce the influence of treatment knowledge on assessments or reporting, depending on the outcome. The registry does not describe the assessment process or how knowledge of dose might have affected toxicity evaluation. No inference about the direction or size of any such influence can be made from the record.
What does the absence of posted analyses imply?
The registry lists 0 analyses and does not provide inferential results for the primary or secondary outcomes. A statistical analysis plan, test selection, model specification, treatment of repeated or time-to-event observations, and approach to uncertainty are not reported in the registry record. It is therefore not possible to assess whether a particular model was appropriate, whether assumptions were checked, or whether results were adjusted for any participant characteristics.
In general, time-to-event outcomes such as time to local-regional control, time to distant recurrence, disease-free survival, and overall survival require information about event timing and follow-up, including how participants without an observed event are handled. Those data and the corresponding analysis methods are not reported in the registry record. Listing an outcome does not itself provide an estimate of its event rate, survival probability, or treatment effect.
Likewise, the registry lists acute and late dose-limiting toxicity outcomes but does not report their outcome values or definitions. A count for toxicity depends on the time window, grading criteria, and rules for attributing events, and a late-toxicity assessment also depends on follow-up. These methodological details cannot be inferred from the outcome names alone.
Why does precision matter?
In general, precision describes how much uncertainty surrounds an estimate. Estimates based on limited observations often have substantial uncertainty, particularly for uncommon events. The registry’s at-risk counts are 3, 3, and 6 across the listed dose groups; those counts indicate that the event summaries are based on limited group sizes. They do not, by themselves, quantify precision. No interval estimates are reported, so the range of plausible underlying event rates cannot be assessed from the registry record.
Over-dispersion is a general statistical issue that arises when count variation is greater than a model assumes. It can lead to overly narrow uncertainty estimates if a model treats counts as less variable than they are. The registry does not report a count model or any model-based uncertainty estimates, so there is no basis to say that over-dispersion was assessed or that it affected the results. This is a general consideration, not a description of an analysis documented for this trial.
Overall, the registry supports a reading of the posted findings as dose-level descriptive safety counts. It does not document the analysis choices needed to turn those observations into a formal inferential conclusion about the maximum tolerated dose, comparative safety, or disease outcomes.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 7 outcome measures. In addition to the primary maximum-tolerated-dose outcome, the secondary outcomes include time to local-regional control, time to distant recurrence, disease-free survival, overall survival, and the number of participants with acute and late dose-limiting toxicities. These address several different clinical questions and may involve distinct outcome definitions and follow-up periods.
When a study evaluates multiple outcomes, multiplicity is a general statistical concern: the chance of at least one apparently notable finding can increase when many hypotheses are tested. Whether and how to address that issue depends on which outcomes are confirmatory, which are exploratory, and what analysis plan was specified. A multiplicity strategy, hypothesis hierarchy, or distinction between confirmatory and exploratory analyses is not reported in the registry record. Since the registry lists 0 analyses, it does not provide tests or estimates from which to evaluate multiplicity in practice.
Missing-data methods and analysis populations are also not reported in the registry record. The record does not specify how participants with incomplete follow-up, missing toxicity assessments, or unavailable outcome information were handled. It does not state whether analyses used all enrolled participants, participants who received treatment, or another defined population. Absence of this information does not establish that data were missing or that a particular exclusion occurred; it means the registry record does not describe those matters.
These omissions limit interpretation of both safety and disease outcomes. For time-to-event endpoints, follow-up and censoring rules are important; for toxicity counts, the number assessed within each window matters. Neither the relevant analysis details nor endpoint results are reported in the registry record. Consequently, the listed outcome names should not be treated as evidence of a measured benefit or as a complete account of how missing observations and multiple outcomes were handled.
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 |
|---|---|---|---|
| Dose Level 1 | 2 | 3 | 66.7% |
| Dose Level 2 | 0 | 3 | 0.0% |
| Dose Level 3 | 1 | 6 | 16.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Dose Level 1 | 1 of 3 |
| Dose Level 2 | 1 of 3 |
| Dose Level 3 | 1 of 6 |
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 |
|---|---|
| Dose Level 1 | 3 of 3 |
| Dose Level 2 | 3 of 3 |
| Dose Level 3 | 6 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | Dose Level 1 | Dose Level 2 | Dose Level 3 |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 1 of 3 | 0 of 3 | 0 of 6 |
| Rectal necrosis | Gastrointestinal disorders | 0 of 3 | 0 of 3 | 1 of 6 |
| Vomiting | Gastrointestinal disorders | 1 of 3 | 0 of 3 | 0 of 6 |
| Dehydration | Metabolism and nutrition disorders | 1 of 3 | 0 of 3 | 0 of 6 |
| Hypokalemia | Metabolism and nutrition disorders | 1 of 3 | 0 of 3 | 0 of 6 |
| Urinary fistula | Renal and urinary disorders | 0 of 3 | 0 of 3 | 1 of 6 |
| Urinary tract obstruction | Renal and urinary disorders | 1 of 3 | 0 of 3 | 0 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dose Level 1 | Dose Level 2 | Dose Level 3 |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 3 of 3 | 2 of 3 | 5 of 6 |
| Diarrhea | Gastrointestinal disorders | 0 of 3 | 2 of 3 | 6 of 6 |
| Fatigue | General disorders | 3 of 3 | 1 of 3 | 4 of 6 |
| Pain | General disorders | 2 of 3 | 2 of 3 | 4 of 6 |
| White blood cell decreased | Investigations | 2 of 3 | 2 of 3 | 3 of 6 |
| Anemia | Blood and lymphatic system disorders | 1 of 3 | 1 of 3 | 3 of 6 |
| Dyspareunia | Reproductive system and breast disorders | 0 of 3 | 1 of 3 | 4 of 6 |
| Vomiting | Gastrointestinal disorders | 1 of 3 | 0 of 3 | 3 of 6 |
| Urinary urgency | Renal and urinary disorders | 2 of 3 | 1 of 3 | 1 of 6 |
| Colitis | Gastrointestinal disorders | 1 of 3 | 0 of 3 | 2 of 6 |
Serious events with the highest arm-level rate: nausea (33.3%), vomiting (33.3%), dehydration (33.3%), hypokalemia (33.3%), urinary tract obstruction (33.3%).
The serious adverse event figures are participant counts within each listed dose group. Dose Level 1 had 2 affected participants among 3 at risk, Dose Level 2 had 0 among 3, and Dose Level 3 had 1 among 6. The other-adverse-event figures were 3 affected among 3 at risk for Dose Level 1, 3 among 3 for Dose Level 2, and 6 among 6 for Dose Level 3. These counts are descriptive and do not adjust for differences among dose groups.
The record reports 1 death in each dose group. It does not report whether the deaths were considered related to the intervention, nor does it provide circumstances or causes. A death count should not be read as proof of treatment causation. Similarly, the serious-event terms and percentages—Nausea, Vomiting, Dehydration, Hypokalemia, and Urinary tract obstruction at 33.3%, and Rectal necrosis at 16.7%—do not establish comparative risk. The registry does not report enough detail about event-level denominators, timing, grading, or attribution to support that interpretation.
Because the study was non-randomized and the groups had limited numbers at risk, the counts do not establish that one dose level is safer than another. They describe adverse events recorded in the registry, not a causal estimate.
12. What the Result Does, and Does Not, Mean
The registry record establishes that IDEAL - GYN was designed to investigate the maximum tolerated dose of integrated boost radiation delivered with concurrent cisplatin for advanced, localized gynecologic cancer. It lists several dose schedules, a primary assessment timeframe from during RT to 6 weeks post RT, and safety counts by dose level. It also lists secondary outcomes concerning local-regional control, distant recurrence, disease-free survival, overall survival, and acute and late dose-limiting toxicity.
The posted data do not state which dose was selected as the maximum tolerated dose. They do not report primary endpoint estimates, statistical tests, confidence intervals, or results for the secondary disease outcomes. As a result, the record cannot establish whether a particular dose met a defined tolerability criterion, how precisely such a decision was estimated, or how tumor control and survival outcomes evolved. Listing an outcome is not the same as reporting its result.
The dose-level safety counts should not be read as a randomized comparison. Allocation was non-randomized, and the record does not document an adjusted analysis or a complete account of dose assignment. The numbers of participants affected by serious and other adverse events are therefore descriptive, not estimates of a causal effect of one dose versus another. The death counts likewise do not indicate treatment attribution.
This distinction matters for clinical interpretation. A dose-finding study may inform a later research decision, but a registry entry with incomplete outcome reporting cannot by itself establish clinical benefit or provide a complete safety profile. General statistical principles also caution that small groups can yield imprecise event estimates, and the registry does not report uncertainty intervals with which to quantify that imprecision.
The appropriate conclusion is limited: the registry describes the study’s purpose, design, dose schedules, and selected adverse-event counts, but it does not report the central dose-finding result or analyses needed to evaluate the listed clinical outcomes. It does not support a conclusion that the intervention works or does not work.
13. Why This Trial Matters Statistically
Statistically, this trial illustrates why design and outcome reporting matter alongside a study’s stated objective. Its primary question is a dose-selection question, not a conventional randomized comparison. The record identifies a non-randomized, single-group design and gives dose schedules, but does not report the final maximum tolerated dose or the full decision rule used to select it. Without those elements, readers cannot reproduce or evaluate the central dose-finding conclusion.
The registry’s safety counts also show why denominators and design context are essential. Counts are presented for groups with 3, 3, and 6 participants at risk. These numbers provide context for the event summaries, but limited group sizes mean that the counts alone cannot precisely characterize underlying event patterns. No interval estimates are reported. The groups were not randomized, so differences in their recorded counts are not necessarily attributable to dose.
A further statistical lesson is that outcome registration and outcome reporting are different. The record lists time-to-event outcomes and acute and late toxicity outcomes, yet does not report their results or analyses. For those outcomes, interpretation would require definitions, follow-up information, analysis populations, and methods for handling incomplete observations. Those details are not reported in the registry record.
The study is therefore informative as a registered dose-escalation effort with a stated toxicity-focused objective and recorded safety counts. It is less informative for estimating comparative effects or drawing conclusions about disease outcomes. Clear reporting of the dose decision, outcome definitions, analysis methods, and uncertainty would be needed to support a fuller statistical assessment.
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 central limitation for interpreting this trial from the registry is that the primary result is not reported in the registry record. The study aimed to determine a maximum tolerated dose, but the record does not state the dose selected or provide the analysis leading to that decision. The toxicity threshold and the complete escalation rules are also not reported, so the dose-finding process cannot be independently assessed from the entry.
The non-randomized, single-group design limits interpretation of differences across dose levels. Participants were not allocated to dose groups by randomization, and the registry does not report adjustment for potential differences among groups. The dose-level counts should not be treated as direct estimates of comparative treatment effects.
The listed safety information is limited to counts and selected serious adverse-event terms. The registry does not report event timing, grading details, attribution, or the circumstances of the deaths. It does not provide uncertainty intervals for the counts. The groups at risk were 3, 3, and 6, so the descriptive summaries are based on limited group sizes.
The record lists secondary disease and toxicity outcomes but does not report their values or statistical analyses. Definitions, follow-up completeness, analysis populations, missing-data procedures, and methods for time-to-event outcomes are not reported in the registry record. The registry lists 0 analyses. This limits evaluation of the precision and robustness of any conclusion and does not establish whether analyses were conducted elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial) — NCT01627288.
- Registry record last updated 2021-02-08; status last verified 2021-02.
- Results first posted 2020-03-10.
- 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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18. Record Summary
NCT01627288 is a completed, non-randomized, single-group study sponsored by Duke University. The registry records enrollment of 12, a start date of 2012-06-04, and a primary completion date of 2018-11-16. Its purpose was to determine the maximum tolerated dose of integrated boost radiation given with concurrent cisplatin for advanced, localized gynecologic cancer.
The record describes dose schedules of 55 Gy, 60 Gy, 65 Gy, and 70 Gy, and gives adverse-event counts for Dose Level 1, Dose Level 2, and Dose Level 3. The primary outcome is stated in Gray (Gy), with a timeframe from during RT to 6 weeks post RT. The registry lists 7 outcome measures and 0 analyses. The numerical maximum tolerated dose, secondary outcome results, and statistical methods are not reported in the registry record.