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 Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma (NCT01390584), a non-randomized phase 2 study. The primary outcome is Progression-free Survival Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01390584 |
| Phase | Phase 2 |
| Condition | Lymphoma |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | ECOG-ACRIN Cancer Research Group |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with bulky stage I or stage II classical Hodgkin lymphoma. The primary endpoint population is described as eligible and treated patients. The registry record reports enrollment of 6, but does not provide enough information to characterize the participants further or to establish how many were eligible and treated for the primary analysis.
Intervention
The study evaluated chemotherapy with treatment guided by PET/CT assessment. The named treatment paths include ABVD + INRT and ABVD + BEACOPP + INRT. The registry describes induction ABVD followed by PET-CT, but the full treatment descriptions and the detailed rules for assigning subsequent therapy are not reported in the registry record.
Comparator
The registry identifies a parallel, nonrandomized study with no masking. The treatment paths are therefore not described as randomized arms or as a like-for-like control comparison. Assignment procedures and the factors that determined which treatment path a patient received are not reported in the registry record.
Primary question
The primary endpoint is the proportion of eligible and treated patients who are alive and progression-free at 36 months. The registry defines progression using new lesions or specified increases in previously identified disease. The primary endpoint result and its 95% confidence interval are not reported in the registry record, so the study's observed progression-free survival cannot be assessed from the posted results.
3. Trial Design
This was a phase II, parallel, nonrandomized study sponsored by ECOG-ACRIN Cancer Research Group. The registry lists the study as terminated and reports enrollment of 6. It identifies no masking. These design features describe how the study was organized; they do not establish why it was terminated or why enrollment was limited. The reason for termination and the planned enrollment are not reported in the registry record.
The clinical question concerned treatment for bulky stage I or stage II classical Hodgkin lymphoma using chemotherapy based on PET/CT assessment. The named paths include ABVD + INRT and ABVD + BEACOPP + INRT. Both descriptions begin with induction ABVD and a PET-CT scan. The posted arm descriptions end before the full treatment details, so the subsequent response-based decisions and complete regimens cannot be reconstructed from the registry record.
Because allocation was nonrandomized, treatment groups cannot be assumed to be comparable at baseline. Differences between groups, if any, could reflect patient characteristics, treatment selection, or other factors rather than treatment itself. The registry record does not report the allocation rules, baseline characteristics, adjustment methods, or a prespecified comparative analysis. It also flags the arms as unsuitable for a like-for-like control comparison. The study is therefore best read as a small phase II investigation with a response-adapted treatment question, not as a randomized estimate of comparative treatment effects.
The registry gives a start date of 2013-05-24 and a primary completion date of 2015-04-09. These dates provide study-record context but do not supply the missing endpoint result. The record names secondary outcomes that include PET status after induction, progression-free survival among PET-positive patients, complete response, overall survival, relapse sites, banking, and biomarker questions. Results for these outcomes 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.
Step 1: Induction Tx (ABVD Then PET/CT)
| Stage | ABVD + INRT | ABVD + BEACOPP + INRT | Induction ABVD |
|---|---|---|---|
| STARTED | 4 | 1 | 1 |
| COMPLETED | 4 | 1 | 0 |
| NOT COMPLETED | 0 | 0 | 1 |
Reasons for not completing this period:
| Reason | ABVD + INRT | ABVD + BEACOPP + INRT | Induction ABVD |
|---|---|---|---|
| Ineligible | 0 | 0 | 1 |
Step 2: ABVD or BEACOPP Then INRT
| Stage | ABVD + INRT | ABVD + BEACOPP + INRT | Induction ABVD |
|---|---|---|---|
| STARTED | 4 | 1 | 0 |
| COMPLETED | 4 | 1 | 0 |
| NOT COMPLETED | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Only eligible and treated patients are included in this analysis
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: Only eligible and treated patients are included.
| Characteristic | Unit | Arm A (ABVD + INRT) | Arm B (ABVD + BEACOPP + INRT) | Total |
|---|---|---|---|---|
| Participants analysed | 4 | 1 | 5 | |
| Age, Continuous | years | 40 (39 to 51) | 35 (35 to 35) | 40 (35 to 51) |
| Sex: Female, Male: Female | Participants | 0 | 1 | 1 |
| Sex: Female, Male: Male | Participants | 4 | 0 | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 | 1 | 5 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| 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 | 4 | 1 | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 4 | 1 | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival Rate, measured over Assessed at 36 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | proportion of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is progression-free survival rate, defined as the proportion of eligible and treated patients who are alive and have not had lymphoma progression at 36 months. The registry defines progression as the appearance of a new lesion meeting its stated size criterion, a specified increase in the sum of products of diameters for previously involved sites or other lesions, or a specified increase in the longest diameter of a previously identified node or extranodal mass meeting its stated short-axis criterion. Death from any cause also counts as an event for this endpoint.
This kind of endpoint combines disease progression and death into a clinically relevant summary over a defined follow-up period. It is used to describe the share of the analysis population who remain alive and progression-free at the specified time. It does not, by itself, show how outcomes compare with another treatment, particularly in a nonrandomized study without a like-for-like control group. Nor does a proportion at one time point describe the timing of each event or the uncertainty around every individual outcome.
The registry specifies a 95% confidence interval as the dispersion measure, but the primary estimate and interval are not reported in the registry record. Consequently, the endpoint's observed value and precision cannot be interpreted from the posted results. The definition and timeframe are recorded, but they are not substitutes for the result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive limitation is that the registry record does not report a primary progression-free survival estimate or its 95% confidence interval. The study's primary endpoint is defined at 36 months, yet no result is posted for the proportion alive and progression-free at that time. There is therefore no observed primary outcome value to describe, and no basis in the record for assessing its precision.
Enrollment was 6, and the study was nonrandomized. These registry entries make careful attention to the analysis population and treatment allocation especially important. The primary analysis is defined for eligible and treated patients, but the record does not report the number in that analysis population or how eligibility and treatment status were applied in practice. The enrolled count should not be treated as the primary endpoint denominator without a reported analysis denominator.
The named treatment paths, ABVD + INRT and ABVD + BEACOPP + INRT, are not a randomized comparison. The registry explicitly cautions that the arms are not a like-for-like control comparison. Any arm-specific outcomes, even if reported, would require contextual information about patient selection and baseline differences before comparative interpretation. The record does not report allocation criteria, baseline summaries, or adjusted comparisons.
The registry lists secondary outcomes, including PET response, complete response, survival, relapse patterns, and biomarker assessments, but does not post outcome analyses for them. It reports no analysis records. Thus, the listed outcomes describe what the study intended to assess, not results that can be interpreted as observed findings. Likewise, the record's termination status does not establish a reason for ending the study, and no reason is reported.
The posted safety figures describe serious and other adverse events within treatment steps. Those figures are descriptive and come from very small risk groups. They do not establish that an event was caused by a particular treatment, and they do not enable a reliable comparison between the nonrandomized treatment paths. A serious-event term listed with a percentage should be read in the context of its reporting denominator, which is not fully explained in the registry record.
In short, the record establishes the design, endpoint definition, and selected safety counts, but it does not provide the primary efficacy result or its uncertainty. No conclusion about the observed 36-month progression-free survival can be drawn from the posted results. The absence of a result is not evidence of a particular outcome.
9. Statistical Methods Explained
The registry describes the primary endpoint as a proportion and names a 95% confidence interval as its uncertainty measure. The endpoint is the proportion of eligible and treated patients alive without progression at 36 months. No estimate or interval for that endpoint is reported in the registry record, so the statistical methods can be explained in general terms without interpreting a study-specific estimate.
What does a confidence interval communicate?
In general, a confidence interval expresses the uncertainty associated with an estimate under a statistical method and its assumptions. For a proportion, the interval helps show how much precision the observed data support. A narrower interval generally indicates greater precision; a wider interval indicates greater uncertainty. The interval does not eliminate uncertainty, prove that a value is correct, or represent a range containing a fixed proportion of individual patient outcomes. Here, the registry specifies a 95% confidence interval, but does not report its endpoints or the estimation method. The precision of the primary estimate therefore cannot be evaluated.
How should a proportion be interpreted?
In general, a proportion is calculated from an event count relative to a defined denominator. Clear interpretation depends on knowing which participants were included, how outcomes were classified, and how missing follow-up was handled. For this study, the registry identifies eligible and treated patients as the primary analysis population. It does not report the size of that population, the number with evaluable follow-up, or the handling of missing endpoint data. The enrolled count alone cannot fill those gaps.
The endpoint is framed at a fixed follow-up time. In general, a fixed-time proportion summarizes status at that time, while a time-to-event analysis uses information about when events occurred and how long participants were followed. The registry calls the primary measure a proportion and specifies assessment at 36 months. The detailed estimation approach, including any treatment of censoring or incomplete follow-up, is not reported in the registry record. It would therefore be inappropriate to assume a particular survival estimator or to infer how participants without complete follow-up contributed.
Why do allocation and analysis populations matter?
In general, random allocation helps balance measured and unmeasured characteristics between treatment groups, on average. Nonrandomized allocation does not provide that protection. Treatment groups can differ for reasons related to prognosis or treatment choice, making direct outcome comparisons vulnerable to confounding. This record labels the design nonrandomized and cautions that its arms are not a like-for-like control comparison. The allocation process and any methods to address group differences are not reported in the registry record.
The specified primary population is eligible and treated patients. In general, restricting an analysis to participants who meet eligibility requirements and receive treatment can answer a different question from analyzing everyone enrolled or assigned. The exact eligibility assessment, exclusions, and analysis rules are not reported. The record also does not report whether analyses used a common population across the treatment paths.
What can the planning illustrations establish?
In general, sample-size planning calculations describe how much information a future study might need under stated assumptions. They are not observed outcomes and do not show the probability that this study detected an effect. The planning approach described in the registry uses a two-sided significance level of 0.05, equal allocation, and a normal approximation, with illustrations tied to fractions of an observed effect. For time-to-event planning, the described quantity is total events; for other planning calculations, it is participants per arm. The calculated illustration values and the observed effect used in those calculations are not reported in the registry record. Such illustrations should not be read as the trial's original design justification or as observed power.
In general, power is a property of a design under specified assumptions, not a retrospective measure of whether a result is true. A small study can yield imprecise estimates, but no numerical precision can be inferred without the endpoint result and its interval. The registry does not report a sample-size justification, interim analyses, or a detailed statistical analysis plan.
How do adverse-event percentages differ from an efficacy estimate?
Safety summaries report affected participants within a stated group and risk set; they do not automatically estimate treatment-attributable risk. The record gives counts at risk and affected for serious and other events in treatment steps, and lists serious-event terms with percentages. In general, interpretation of a term-specific percentage requires a clear definition of its denominator and whether the percentage refers to participants or event occurrences. The record does not provide enough detail to resolve every denominator or establish causality. With small groups and nonrandomized treatment paths, raw safety counts are descriptive rather than a sound basis for comparative inference.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several secondary outcomes alongside the primary progression-free survival endpoint. These include PET-negative status after induction, progression-free survival among PET-positive patients, complete response, overall survival, relapse sites, and laboratory or tissue biomarker questions. Examining multiple outcomes can increase the chance of finding an apparently notable result by chance if no multiplicity strategy is used. The statistical approach for handling multiple outcomes or comparisons is not reported in the registry record. The record reports no analysis records, and the listed secondary outcomes do not have posted results.
Missing-data handling is also not reported in the registry record. In general, incomplete outcome ascertainment can affect a fixed-time proportion if participants with unknown status are treated differently from those with known status. The record does not describe how lost follow-up, incomplete assessments, or other unavailable endpoint data were handled, nor does it report sensitivity analyses. No assumptions about these procedures should be inferred from the endpoint definition.
The primary analysis population is described as eligible and treated patients. The record does not give the size of that population or describe exclusions between enrollment and analysis. It does not report whether any other analysis populations were specified. These omissions matter because the analyzed population and the handling of missing outcomes determine what the estimate would represent.
The nonrandomized design adds a separate limitation: outcome comparisons between treatment paths may reflect differences in who received each path. Adjustment methods and the details of allocation are not reported. Consequently, neither multiplicity control nor missing-data methods can be evaluated from the posted results, and no comparative inference should be assumed.
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 |
|---|---|---|---|
| Step 1: Induction Treatment | 5 | 6 | 83.3% |
| Step 2: ABVD + INRT | 3 | 4 | 75.0% |
| Step 2: BEACOPP + INRT | 1 | 1 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Step 1: Induction Treatment | 0 of 6 |
| Step 2: ABVD + INRT | 0 of 4 |
| Step 2: BEACOPP + INRT | 0 of 1 |
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 |
|---|---|
| Step 1: Induction Treatment | 6 of 6 |
| Step 2: ABVD + INRT | 4 of 4 |
| Step 2: BEACOPP + INRT | 1 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | Step 1: Induction Treatment | Step 2: ABVD + INRT | Step 2: BEACOPP + INRT |
|---|---|---|---|---|
| Neutrophil count decreased | Investigations | 4 of 6 | 3 of 4 | 1 of 1 |
| Lymphocyte count decreased | Investigations | 1 of 6 | 1 of 4 | 0 of 1 |
| White blood cell decreased | Investigations | 0 of 6 | 1 of 4 | 1 of 1 |
| Anemia | Blood and lymphatic system disorders | 0 of 6 | 0 of 4 | 1 of 1 |
| Febrile neutropenia | Blood and lymphatic system disorders | 0 of 6 | 0 of 4 | 1 of 1 |
| Fatigue | General disorders | 0 of 6 | 0 of 4 | 1 of 1 |
| Infections and infestations - Other, specify | Infections and infestations | 0 of 6 | 1 of 4 | 0 of 1 |
| Platelet count decreased | Investigations | 0 of 6 | 0 of 4 | 1 of 1 |
| Hypothyroidism | Endocrine disorders | 0 of 6 | 0 of 4 | 0 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Step 1: Induction Treatment | Step 2: ABVD + INRT | Step 2: BEACOPP + INRT |
|---|---|---|---|---|
| Fatigue | General disorders | 4 of 6 | 4 of 4 | 1 of 1 |
| White blood cell decreased | Investigations | 5 of 6 | 3 of 4 | 1 of 1 |
| Anemia | Blood and lymphatic system disorders | 3 of 6 | 4 of 4 | 0 of 1 |
| Nausea | Gastrointestinal disorders | 3 of 6 | 1 of 4 | 1 of 1 |
| Neutrophil count decreased | Investigations | 2 of 6 | 3 of 4 | 0 of 1 |
| Alopecia | Skin and subcutaneous tissue disorders | 1 of 6 | 3 of 4 | 0 of 1 |
| Constipation | Gastrointestinal disorders | 2 of 6 | 1 of 4 | 1 of 1 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 6 | 3 of 4 | 0 of 1 |
| Peripheral sensory neuropathy | Nervous system disorders | 2 of 6 | 1 of 4 | 0 of 1 |
| Non-cardiac chest pain | General disorders | 1 of 6 | 1 of 4 | 0 of 1 |
Serious events with the highest arm-level rate: anemia (100.0%), febrile neutropenia (100.0%), fatigue (100.0%), neutrophil count decreased (100.0%), platelet count decreased (100.0%).
The registry reports adverse-event summaries for Step 1: Induction Treatment, Step 2: ABVD + INRT, and Step 2: BEACOPP + INRT. For serious adverse events, the recorded at-risk and affected counts are 6 and 5 for induction, 4 and 3 for ABVD + INRT, and 1 and 1 for BEACOPP + INRT. For other adverse events, the corresponding counts are 6 and 6, 4 and 4, and 1 and 1. These are counts within the separate registry groups; they should not be added or treated as a randomized comparison.
The registry also lists anemia, febrile neutropenia, fatigue, decreased neutrophil count, decreased platelet count, and decreased white blood cell count as serious terms, each with a reported 100.0%. The record does not fully explain the denominator for these term percentages or whether the listing represents participants or events. The percentages should therefore be read as registry-reported summaries, not as independently interpretable treatment risks.
These safety data are descriptive. They do not establish that treatment caused an event, and the small at-risk groups limit what can be concluded about frequency or differences between regimens. The registry reports zero deaths in each listed group. This safety summary does not replace the unreported primary progression-free survival result.
12. What the Result Does, and Does Not, Mean
The registry record documents a phase II study of PET-adapted chemotherapy and radiation approaches for bulky stage I or stage II classical Hodgkin lymphoma. It defines a primary endpoint: the proportion of eligible and treated patients who are alive and progression-free at 36 months. It also provides a progression definition and names a 95% confidence interval as the measure of uncertainty.
However, the primary estimate and its confidence interval are not reported in the registry record. The listed secondary outcomes likewise have no posted results. Thus, the record does not show the observed progression-free survival, PET response, complete response, or other listed outcome values. This absence does not mean that no events occurred or that an outcome was favorable or unfavorable; it means the record does not report those results.
The nonrandomized design also limits interpretation of treatment-path comparisons. The registry explicitly cautions that the arms are not a like-for-like control comparison. Any group differences could reflect selection or other differences, and the record does not report allocation details or adjusted analyses. The safety counts should likewise be treated as descriptive and not as evidence of treatment causation.
The posted information can support an understanding of the study question, design, endpoint definition, and recorded safety summaries. It cannot support a conclusion about the magnitude or precision of the primary outcome, nor a comparative conclusion about the treatment paths. The study's termination status alone does not explain why it ended or supply evidence about efficacy. Any interpretation should remain within those limits.
13. Why This Trial Matters Statistically
This study illustrates why a clearly defined endpoint is only one part of a statistical result. The registry specifies progression-free survival at 36 months and details what counts as progression, but does not report the estimate or its confidence interval. Without those results, readers cannot evaluate the observed outcome or its precision. A protocol-level definition and a posted outcome are different kinds of information.
The record also illustrates the interpretive challenges of a small nonrandomized study. Enrollment was 6, and the registry identifies multiple treatment paths while cautioning that they are not like-for-like controls. In general, nonrandomized groups may differ in ways that influence outcomes. Clear reporting of allocation, analysis populations, baseline features, and adjusted methods is important for understanding whether group comparisons are meaningful; those details are not reported in the registry record.
Safety summaries require similar care. The registry provides at-risk and affected counts and lists serious-event terms with percentages, but the small groups and incomplete denominator detail limit interpretation. Counts are not causal comparisons, and a term-specific percentage cannot be fully evaluated without knowing how its denominator was defined.
Finally, the record names multiple secondary outcomes but does not report their analyses or a multiplicity strategy. This matters because readers need to distinguish intended measurements from observed findings and to understand how multiple questions were handled. Taken together, the record demonstrates the value of complete outcome reporting: design and endpoint definitions can clarify a study's aims, but they cannot substitute for estimates, uncertainty measures, and transparent analysis details.
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 primary limitation for interpretation is the absence of a reported progression-free survival estimate and 95% confidence interval. Although the endpoint and its 36-month timeframe are defined, the posted results do not establish the observed endpoint value. Secondary outcomes are listed without reported results, so they do not fill this gap.
The study's enrollment was 6, and its design was nonrandomized. The registry cautions that the treatment paths are not a like-for-like control comparison. Allocation criteria, baseline participant characteristics, and adjustment methods are not reported in the registry record. These omissions prevent assessment of how treatment selection may have related to prognosis or other outcome-relevant factors.
The primary population is defined as eligible and treated patients, but the record does not report the size of that population or explain how enrollment translated into the primary analysis. Missing outcome data, follow-up completeness, censoring, and sensitivity analyses are not described. As a result, the endpoint denominator and the handling of incomplete assessment cannot be evaluated.
The treatment descriptions are incomplete in the registry record. They identify induction ABVD, PET-CT assessment, and named treatment paths, but do not provide the full response-adapted decision rules. The reason the study was terminated is also not reported; termination status alone should not be interpreted as evidence about outcome or study conduct.
Safety results are limited to the recorded counts and term percentages. Denominator details for each listed serious-event percentage are not fully explained, and the data do not establish causation. The registry also does not report a detailed statistical plan, multiplicity handling, interim analyses, or a sample-size justification. These limitations restrict both efficacy and safety interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma — NCT01390584.
- Registry record last updated 2023-06-29; status last verified 2023-06.
- Results first posted 2020-12-22.
- 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
The registry describes a phase II, parallel, nonrandomized study of PET-adapted treatment for bulky stage I or stage II classical Hodgkin lymphoma. It reports enrollment of 6, no masking, and terminated status. The primary endpoint is the proportion of eligible and treated patients alive and progression-free at 36 months, with a 95% confidence interval specified. The endpoint result and interval are not reported in the registry record.
Named treatment paths include ABVD + INRT and ABVD + BEACOPP + INRT. The registry cautions that the arms are not a like-for-like control comparison. It lists secondary outcomes but reports no analyses. Safety summaries include serious and other adverse-event counts by treatment step and several serious-event terms with percentages. The record does not report the termination reason, allocation details, missing-data methods, or multiplicity approach.