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 Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma (NCT00302003), a na phase 3 study. The primary outcome is Event Free Survival Without Receiving Radiation Therapy (EFSnoRT)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00302003 |
| Phase | Phase 3 |
| Condition | Childhood Favorable Prognosis Hodgkin Lymphoma, Childhood Lymphocyte Depletion Hodgkin Lymphoma, Childhood Mixed Cellularity Hodgkin Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 287 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Children's Oncology Group |
| Results posted | Yes |
2. Clinical Question
Population
Children and adolescents with newly diagnosed low-risk Hodgkin disease were the intended population. The listed conditions include favorable-prognosis disease, several Hodgkin lymphoma subtypes, and stage I or stage II childhood Hodgkin lymphoma. The primary-outcome population is described as 278 eligible patients, with response and response review evaluable for 275.
Intervention
The study examined combination chemotherapy followed by radiation therapy and/or additional chemotherapy. The registry lists chemotherapy drugs and radiation therapy. The described treatment arm is named for doxorubicin, vincristine, cyclophosphamide and filgrastim, and its description refers to three cycles. The full treatment sequence is not reported in the registry record.
Comparator
The registry identifies a single-group model and does not specify a randomized allocation or a concurrent control group. It therefore does not define a like-for-like comparison between assigned treatment groups. The central statistical question is about the outcome observed in the study group, not a treatment contrast against a control arm.
Primary question
At 60 months, what is the probability of event-free survival without receiving radiation therapy? An event is defined by the need for additional chemotherapy and IFRT for retrieval, a second malignant neoplasm, or death from any cause. The registry record gives the endpoint definition but does not report a numeric estimate or confidence interval for the result.
3. Trial Design
This was a phase III study sponsored by Children's Oncology Group. The registry describes a single-group model, with allocation listed as NA and masking listed as none. The study status is completed. Its listed enrollment is 287. The study start is recorded as 2006-02 and primary completion as 2012-03.
The official title describes treatment of children and adolescents with newly diagnosed low-risk Hodgkin disease. The intervention description focuses on combination chemotherapy before radiation therapy and/or additional chemotherapy. Listed interventions include radiation therapy and several chemotherapy drugs. One named arm describes doxorubicin, vincristine, cyclophosphamide and filgrastim, but the full regimen and treatment sequence are not reported in the registry record.
The primary-outcome population is stated as eligible patients (n=278), with response and response review evaluable for 275. These figures describe different analysis descriptions in the registry; they should not be treated as interchangeable populations. The registry also reports that censored patients (n=138) had follow-up of 76 months, with a range from 1.8 to 108 months.
Because the design is single-group and allocation is NA, the record does not establish a randomized treatment comparison. The study can describe outcomes in its registered population, but the design does not by itself separate treatment effects from other factors that could influence those outcomes. Details of a control group, randomization process, or masking procedure 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 | Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim |
|---|---|
| STARTED | 287 |
| COMPLETED | 207 |
| NOT COMPLETED | 80 |
Reasons for not completing this period:
| Reason | Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim |
|---|---|
| Lack of Efficacy | 62 |
| Lost to Follow-up | 1 |
| Physician Decision | 2 |
| Withdrawal by Subject | 5 |
| Ineligible | 9 |
| Protocol Violation | 1 |
Analysis population for the primary outcome, as defined in the registry: Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).
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 | Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim |
|---|---|---|
| Participants analysed | 287 | |
| Age, Categorical: <=18 years | Participants | 272 |
| Age, Categorical: Between 18 and 65 years | Participants | 15 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | Years | 15 (3 to 21) |
| Sex: Female, Male: Female | Participants | 160 |
| Sex: Female, Male: Male | Participants | 127 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 43 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 227 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 17 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 3 |
| Race (NIH/OMB): Asian | Participants | 8 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 29 |
| Race (NIH/OMB): White | Participants | 220 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 27 |
| Region of Enrollment: United States | participants | 250 |
| Region of Enrollment: Australia | participants | 3 |
| Region of Enrollment: Canada | participants | 25 |
| Region of Enrollment: Israel | participants | 1 |
| Region of Enrollment: Mexico | participants | 1 |
| Region of Enrollment: New Zealand | participants | 2 |
| Region of Enrollment: Puerto Rico | participants | 4 |
| Region of Enrollment: Switzerland | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Event Free Survival Without Receiving Radiation Therapy (EFSnoRT)., measured over At 60 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Probability of survival |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is event-free survival without receiving radiation therapy (EFSnoRT), assessed at 60 months. It is expressed as a probability of survival, with a 95% confidence interval specified as the measure of uncertainty. The endpoint is designed to capture whether patients remain free of specified events while avoiding radiation therapy.
The registry defines an event as the minimum time from study entry to any of the following: a requirement for additional chemotherapy and IFRT for retrieval, a second malignant neoplasm, or death from any cause. Patients without a reported event are censored at their last contact. The definition also treats patients who have less than CR after three cycles of AV-PC as having an event when response is evaluated, because they require IFRT. A patient who achieves CR but later relapses is counted at the first relapse of Hodgkin disease, when additional chemotherapy and IFRT or intense retrieval are required.
As a general statistical point, a time-to-event endpoint can incorporate both whether an event occurs and when it occurs, while accounting for follow-up that ends before an event is recorded. The registry record does not report the numeric 60-month estimate or its confidence interval, so the outcome’s magnitude and precision cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically specific primary outcome: event-free survival without radiation therapy at 60 months. It defines the events and describes how patients without reported events are censored. However, it does not provide the numeric outcome estimate or its 95% confidence interval. Consequently, the record does not allow a reader to determine the observed probability, the width of its uncertainty interval, or how compatible the result is with different possible values.
The eligible population is stated as 278, and response and response review were evaluable for 275. These descriptions indicate that the endpoint population and the evaluable-response population are not identical as recorded. The record does not explain the difference in analysis status or give the reasons for non-evaluability. It also reports 138 censored patients and follow-up of 76 months for those patients, with a range from 1.8 to 108 months. These details characterize follow-up but do not replace the missing endpoint estimate.
The study is registered as single group, with allocation listed as NA. No concurrent control comparison is specified. Any interpretation should therefore focus on outcomes in the study population and not treat the result as a randomized estimate of the difference between two treatment strategies. The design does not establish what would have happened to comparable patients under an alternative strategy.
The registry lists 287 participants as enrolled, but enrollment alone does not indicate how many contributed to a particular outcome analysis. The endpoint’s stated eligible and evaluable populations should be read as distinct analytic descriptions, not combined or substituted for one another. The registry record does not report the estimator, the number of primary-endpoint events, or further analysis details that would clarify the calculation.
The posted safety counts describe serious and other adverse events in the named group, but they do not fill the gap in the primary efficacy result. Likewise, the named secondary outcome is overall survival, but a numeric result for it is not reported in the registry record. The available information supports a description of the study design, endpoint definition, follow-up, and selected safety counts; it does not support a conclusion about the size or precision of the primary outcome.
9. Statistical Methods Explained
What does the endpoint’s confidence interval communicate?
The registry specifies a 95% confidence interval for the primary endpoint, but does not report the interval’s limits. General explanation: a confidence interval describes the uncertainty around an estimate under the statistical method used. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. Without the estimate and interval, readers cannot assess the reported level of precision or judge which values remain compatible with the data under that method. A confidence interval is not a guarantee that the true value lies within a particular interval, and it does not describe the probability that a treatment works.
How should time-to-event follow-up be understood?
The primary endpoint uses time from study entry to the first qualifying event. The registry states that patients without a report of a specified event are censored at last contact. General explanation: censoring means the event time is not observed during the person’s recorded follow-up; it does not mean the person experienced no event ever. Time-to-event methods use the follow-up information available up to censoring, subject to assumptions about how censoring relates to event risk. The method used and its assumptions are not reported in the registry record.
The registry gives follow-up for censored patients as 76 months, with a range from 1.8 to 108 months. It does not identify the summary measure represented by 76 months, so it should not be described as a mean or median. It also does not report the number of primary-endpoint events or the event-time distribution. These omissions limit independent assessment of how the 60-month probability was estimated.
Why does the event definition matter?
The endpoint is not simply a measure of survival from death. It also counts specified treatment and disease events, including the requirement for additional chemotherapy and IFRT for retrieval and a second malignant neoplasm. The registry further defines response-based circumstances that qualify: less than CR after three cycles of AV-PC is treated as an event at response evaluation, and relapse after CR is treated as an event at the first relapse. General explanation: a composite endpoint combines multiple event types into one outcome. Its interpretation depends on the included events, because different events can have different clinical meanings and frequencies. The registry’s definition should therefore be kept in view when interpreting any eventual estimate.
What can the planning assumptions tell readers?
The registry describes a sample-size 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. The effect to detect is described as a stated fraction of the observed effect. Time-to-event planning uses a total event count; other planning outputs are expressed as participants per arm. These assumptions describe a planning illustration, not the trial’s own design or an observed result. They do not establish that the study was randomized or that the trial actually used equal allocation. The registry record does not report numeric planning outputs in the registry record for this account, nor does it report the protocol’s sample-size justification. Planning sample sizes are not observed power.
General explanation: power calculations are prospective planning tools that depend on assumptions about the effect to detect, variability, significance level, allocation, and analysis method. A calculation based on an observed effect is especially dependent on that estimate and should not be read as evidence that the study had a particular probability of detecting a true effect. In this study record, the absence of the primary numerical estimate means readers cannot use the planning assumptions to reconstruct the observed outcome.
The registry lists 0 analyses. That entry does not establish that no statistical analyses were performed; it means the registry record does not list analyses in that field. The specific estimator, handling of any competing events, model specification, and any adjustment strategy are not reported in the registry record. Those details matter for understanding how a time-to-event probability and its uncertainty were obtained.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures and names overall survival as a secondary outcome. It lists 0 analyses, so the record does not provide analysis-level details for the outcomes. The primary outcome is defined, but the registry record does not report its numerical estimate or confidence interval. Numeric results for the named secondary outcome are also not reported in the registry record.
Multiplicity arises when several outcomes, comparisons, time points, or subgroup analyses are examined. General explanation: testing many questions can increase the chance of at least one apparently notable result, so a statistical plan may specify how to interpret or adjust for multiple analyses. The registry record does not report a multiplicity adjustment, a hierarchy among outcomes, or whether additional analyses were planned. It would be inappropriate to infer that multiplicity was or was not addressed in the study’s full analysis.
The record states that patients without a reported qualifying event were censored at last contact. It does not report further missing-data procedures, imputation, sensitivity analyses, or reasons for missing outcome information. The count of censored patients is 138; their stated follow-up is 76 months, with a range from 1.8 to 108 months. The record does not describe whether censoring patterns were examined or how assumptions about censoring were assessed.
The primary-outcome description identifies 278 eligible patients and 275 evaluable for response and response review. The registry does not explain how these populations were used in the primary analysis or why they differ. It does not specify an intention-to-treat population or another formal analysis-population label. Those omissions make it difficult to assess how completely the outcome analysis represents the enrolled group.
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 |
|---|---|---|---|
| Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim | 2 | 278 | 0.7% |
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 |
|---|---|
| Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim | 80 of 278 |
Most frequent serious adverse event terms
| Event term | Organ system | Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim |
|---|---|---|
| Infections and infestations - Other, specify | Infections and infestations | 1 of 278 |
| CPK increased | Investigations | 1 of 278 |
| Acidosis | Metabolism and nutrition disorders | 1 of 278 |
| Thromboembolic event | Vascular disorders | 1 of 278 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim |
|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 18 of 278 |
| Infections and infestations - Other, specify | Infections and infestations | 12 of 278 |
| Nausea | Gastrointestinal disorders | 10 of 278 |
| Vomiting | Gastrointestinal disorders | 10 of 278 |
| Neutrophil count decreased | Investigations | 7 of 278 |
| Hypokalemia | Metabolism and nutrition disorders | 7 of 278 |
| White blood cell decreased | Investigations | 6 of 278 |
| Mucositis oral | Gastrointestinal disorders | 4 of 278 |
| Fatigue | General disorders | 4 of 278 |
| Vascular access complication | Injury, poisoning and procedural complications | 4 of 278 |
Serious events with the highest arm-level rate: infections and infestations - other, specify (0.4%), cpk increased (0.4%), acidosis (0.4%), thromboembolic event (0.4%).
The registry reports serious adverse events for the named doxorubicin, vincristine, cyclophosphamide and filgrastim group. It lists 278 at risk for serious events and 2 affected. For other adverse events, it lists 278 at risk and 80 affected. These are registry counts, not a comparison against a control group. The record does not provide a randomized comparator for interpreting differences in safety.
Four serious-event terms are listed with the same reported percentage: infections and infestations - other, specify; CPK increased; acidosis; and thromboembolic event. Each is recorded as 0.4%. These term-level entries should be read as the registry’s reported categories and percentages; they do not establish whether the same or different patients contributed to multiple categories. No totals should be inferred from the list.
The death field is null, so a death count is not reported in the registry record. The record does not provide further detail about event timing, duration, severity grading, attribution, or how events were collected. As a general statistical point, adverse-event counts describe events observed under the recording and follow-up procedures; without a comparator and fuller reporting, they do not establish a causal treatment effect or provide a complete account of risk.
12. What the Result Does, and Does Not, Mean
The study record defines a primary outcome that combines freedom from specified events with avoidance of radiation therapy, assessed at 60 months. It also records a single-group design, a completed status, an enrollment of 287, and details about the endpoint population and follow-up. These registry entries help readers understand what the study set out to assess and how the endpoint was defined.
The record does not report the numerical primary-outcome result or its confidence interval. It therefore does not show the observed probability of event-free survival without radiation therapy, nor how precisely that probability was estimated. The named secondary outcome is overall survival, but a numerical result for it is not reported in the registry record either. No conclusion about the direction, size, or precision of the outcome can be drawn from the endpoint definition alone.
The single-group design does not provide a concurrent randomized control contrast. Even if an outcome estimate were available, it would describe the study group and would not, by itself, establish what would have occurred under another treatment strategy. General explanation: causal comparisons require a suitable counterfactual comparison, and a single-group registry record cannot directly supply one.
The safety counts offer a limited description of reported adverse events in the named group. They do not establish a comparative safety difference, and the record does not give a death count. The primary endpoint, safety counts, and enrollment figure answer different questions; none can substitute for another.
Accordingly, the strongest interpretation is descriptive: the registry specifies the intended population, treatment approach, endpoint criteria, follow-up information, and selected adverse-event counts. The absence of numerical efficacy results and detailed analysis methods limits assessment of both outcome magnitude and uncertainty. The record alone does not support a treatment recommendation or a claim that the strategy does or does not work.
13. Why This Trial Matters Statistically
This trial is statistically notable for asking a time-to-event question that incorporates both disease or safety events and the use of radiation therapy. Its EFSnoRT definition makes the endpoint more specific than overall survival: specified treatment requirements, a second malignant neoplasm, and death all count, with additional response-based rules. Readers need the endpoint definition to interpret what a probability of survival represents.
The study is registered as a single-group phase III trial, with allocation listed as NA. That design distinction is important because outcome probabilities in one group are not the same as randomized differences between groups. Statistical interpretation should not turn a single-group result into a controlled treatment effect.
The registry also distinguishes eligible patients from those evaluable for response review and reports censoring and follow-up information. These details matter because outcome estimates depend on who contributes to an analysis and how incomplete follow-up is handled. The record does not report enough analysis detail to evaluate those choices fully, and it does not give the numerical primary result.
Finally, this record illustrates why endpoint definitions, analysis populations, uncertainty intervals, and comparator structure all matter alongside an enrollment figure. A clearly specified endpoint can make the intended question understandable, but the absence of its estimate and confidence interval leaves the central empirical answer unavailable in the registry record. The design and reporting information can still be described without claiming more than the record supports.
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 important limitation for statistical interpretation is that the registry record does not report a numeric result or confidence interval for the primary endpoint. Without these, readers cannot evaluate the estimated 60-month probability or its precision. A definition of an outcome is not a report of its observed value.
The single-group design and NA allocation do not provide a registered concurrent randomized comparison. Any description of outcomes is therefore limited to the study group; the record cannot establish a comparative treatment effect. The masking field is listed as none, and further details of assessment procedures are not reported in the registry record.
The registry identifies 278 eligible patients and 275 evaluable for response and response review, but does not explain the difference or specify how these groups enter the primary analysis. It reports 138 censored patients and follow-up of 76 months for censored patients, with a range from 1.8 to 108 months, but does not describe the censoring assumptions or sensitivity analyses. The estimator, event count, and detailed analysis plan are not reported in the registry record.
The treatment-arm description is incomplete as presented: although an arm is named and several interventions are listed, the full treatment sequence is not reported in the registry record. The record also does not report numeric results for the named secondary outcome, overall survival, or a death count in the safety entry. These reporting limits restrict assessment of efficacy, safety, and analysis choices.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma — NCT00302003.
- Registry record last updated 2021-03-30; status last verified 2016-08.
- Results first posted 2017-02-09.
- 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
NCT00302003 is a completed phase III, single-group study sponsored by Children's Oncology Group. The record describes treatment for children and adolescents with newly diagnosed low-risk Hodgkin disease. Enrollment is listed as 287; the study start is 2006-02 and primary completion is 2012-03.
The primary outcome is event-free survival without receiving radiation therapy at 60 months. The endpoint definition includes specified treatment requirements, a second malignant neoplasm, and death, with patients without reported events censored at last contact. The record identifies 278 eligible patients and 275 evaluable for response and response review. For censored patients, it reports follow-up of 76 months, ranging from 1.8 to 108 months.
The registry record does not report the numeric primary-outcome estimate or its confidence interval. It names overall survival as a secondary outcome and records selected serious and other adverse-event counts for the named treatment group. A concurrent randomized comparator and detailed analysis methods are not reported.