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 Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer (NCT00940316), a randomized phase 2 study. The primary outcome is Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00940316 |
| Phase | Phase 2 |
| Condition | Colorectal Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 28 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Northwestern University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with metastatic colorectal cancer receiving second-line therapy. The registry lists colorectal cancer as the condition and records enrollment of 28. It does not report additional eligibility details or a primary-outcome analysis population in the registry record.
Intervention
One treatment group received erlotinib hydrochloride and panitumumab with irinotecan hydrochloride. The registry describes erlotinib as oral treatment on days 1-14 and the other drugs as intravenous treatment on day 1, with treatment repeating every 2 weeks unless disease progression or unacceptable toxicity occurred.
Comparator
The registry also describes erlotinib hydrochloride and panitumumab without irinotecan as a treatment group. It lists a separate Arm C with the same regimen description as Arm B. Upon progression, patients in Arm B were to receive irinotecan as in Arm A; the registry does not explain the relationship between Arms B and C.
Primary question
The trial asked how the tumor response outcome, defined as complete response, partial response, or stable disease, compared under the listed treatment approaches. The primary outcome was assessed using imaging and RECIST v1.0. Response counts by arm and a statistical comparison are not reported in the registry record, so the treatment contrast cannot be evaluated from the posted primary-outcome information.
3. Trial Design
This was a randomized, open-label, parallel phase II study sponsored by Northwestern University. The registry lists enrollment of 28 and describes three arms. Arm A combined erlotinib, panitumumab, and irinotecan. Arm B used erlotinib and panitumumab, with irinotecan given after disease progression. Arm C is described as receiving erlotinib and panitumumab as in Arm B. The registry record does not explain why the two dual-inhibition arms are listed separately or provide further detail on their distinction.
For Arm A, erlotinib hydrochloride was taken orally once daily on days 1-14, while panitumumab and irinotecan hydrochloride were given intravenously on day 1. For Arm B, erlotinib was taken on days 1-14 and panitumumab was given intravenously on day 1. Treatment was scheduled to repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. The description of Arm C refers to the Arm B regimen.
The study start is recorded as 2010-01-18, primary completion as 2015-01, and status as completed. Masking is listed as none. The registry gives the study purpose as evaluating the dual-inhibition regimen with or without irinotecan as second-line therapy for metastatic colorectal cancer. It does not report allocation proportions, the randomization procedure, or the reason for the separate Arm C description. Those details should not be inferred from the arm labels or the safety 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: Subjects with either 6/6 UGT1A1 genotype or 6/7 UGT1A1 genotype will be randomized into either Arm A and Arm B. Subjects with 7/7 UGT1A1 genotype enrolled in Arm C.
Reached First Response at 8 Weeks
| Stage | Arm A: Erlotinib + Panitumumab + Irinotecan | Arm B: Erlotinib + Panitumumab | Arm C: Erlotinib + Panitumumab |
|---|---|---|---|
| STARTED | 13 | 13 | 2 |
| COMPLETED | 10 | 9 | 2 |
| NOT COMPLETED | 3 | 4 | 0 |
Reasons for not completing this period:
| Reason | Arm A: Erlotinib + Panitumumab + Irinotecan | Arm B: Erlotinib + Panitumumab | Arm C: Erlotinib + Panitumumab |
|---|---|---|---|
| Adverse Event | 2 | 1 | 0 |
| Progressive disease | 1 | 3 | 0 |
Moved on to be Treated Cycle 5
| Stage | Arm A: Erlotinib + Panitumumab + Irinotecan | Arm B: Erlotinib + Panitumumab | Arm C: Erlotinib + Panitumumab |
|---|---|---|---|
| STARTED | 10 | 9 | 2 |
| COMPLETED | 8 | 9 | 2 |
| NOT COMPLETED | 2 | 0 | 0 |
Reasons for not completing this period:
| Reason | Arm A: Erlotinib + Panitumumab + Irinotecan | Arm B: Erlotinib + Panitumumab | Arm C: Erlotinib + Panitumumab |
|---|---|---|---|
| Adverse Event | 2 | 0 | 0 |
Treated After Cycle 5
| Stage | Arm A: Erlotinib + Panitumumab + Irinotecan | Arm B: Erlotinib + Panitumumab | Arm C: Erlotinib + Panitumumab |
|---|---|---|---|
| STARTED | 8 | 9 | 2 |
| COMPLETED | 8 | 8 | 1 |
| NOT COMPLETED | 0 | 1 | 1 |
Reasons for not completing this period:
| Reason | Arm A: Erlotinib + Panitumumab + Irinotecan | Arm B: Erlotinib + Panitumumab | Arm C: Erlotinib + Panitumumab |
|---|---|---|---|
| Adverse Event | 0 | 0 | 1 |
| Progressive disease | 0 | 1 | 0 |
Crossed Over to Arm A After Progression
| Stage | Arm A: Erlotinib + Panitumumab + Irinotecan | Arm B: Erlotinib + Panitumumab | Arm C: Erlotinib + Panitumumab |
|---|---|---|---|
| STARTED | 0 | 3 | 0 |
| Treated for Cycle One | 0 | 3 | 0 |
| COMPLETED | 0 | 3 | 0 |
| NOT COMPLETED | 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.
| Characteristic | Unit | Arm A: Erlotinib + Panitumumab + Irinotecan | Arm B: Erlotinib + Panitumumab | Arm C: Erlotinib + Panitumumab | Total |
|---|---|---|---|---|---|
| Participants analysed | 13 | 13 | 2 | 28 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 8 | 9 | 2 | 19 |
| Age, Categorical: >=65 years | Participants | 5 | 4 | 0 | 9 |
| Sex: Female, Male: Female | Participants | 6 | 5 | 0 | 11 |
| Sex: Female, Male: Male | Participants | 7 | 8 | 2 | 17 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 2 | 0 | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 | 11 | 2 | 23 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 1 | 3 |
| Race (NIH/OMB): White | Participants | 12 | 12 | 1 | 25 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 13 | 13 | 2 | 28 |
| UGT1A1 genotyping 6/6 | Participants | 9 | 7 | 0 | 16 |
| UGT1A1 genotyping 6/7 | Participants | 4 | 6 | 0 | 10 |
| UGT1A1 genotyping 7/7 | Participants | 0 | 0 | 2 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD), measured over At baseline and every 8 weeks during treatment until progressive disease for maximum of 51 cycles where 1 cycle = 2 weeks..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled tumor response rate based on complete response, partial response, and stable disease. It is measured as a count of participants. The registry says tumor response was evaluated with chest CT and abdominal and pelvic CT or MRI at baseline and every 8 weeks during treatment until progressive disease, for a maximum of 51 cycles, where 1 cycle = 2 weeks.
Under the stated RECIST v1.0 definitions, complete response means disappearance of all target lesions. Partial response requires at least a 30% decrease in the sum of the longest diameters of target lesions relative to baseline. Progressive disease is defined as at least a 20% increase relative to the smallest recorded sum since treatment began, or the appearance of one or more new lesions. Stable disease is neither enough shrinkage for partial response nor enough increase for progressive disease, using the smallest sum since treatment began as the reference.
Combining complete response, partial response, and stable disease groups participants whose disease has not met the stated progression criteria, while distinguishing categories that represent different observed tumor changes. Such an endpoint can summarize disease status at assessment, but it does not by itself describe how long that status lasts. The registry record does not report the category counts, response rate estimates, or arm comparisons, so the endpoint's observed results cannot be interpreted from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive limitation is that the registry record describes the primary response endpoint but does not report its results. It gives no count of participants with complete response, partial response, or stable disease for any arm, and no arm-level response estimate or statistical comparison. Consequently, the posted information does not establish whether response differed across the listed regimens, or how precise any difference might have been. The absence of a reported comparison is not evidence that the treatments had equal outcomes.
The study was randomized and parallel, but it was also open-label. Randomization is intended to support fair comparisons by assigning treatment without selection based on prognosis; the record does not describe the randomization method or allocation proportions. Open-label status means masking is listed as none. General statistical context: lack of masking can influence outcomes involving judgment or participant and clinician behavior, while imaging-based criteria can apply explicit definitions. The record does not say whether image assessments were independently reviewed or blinded.
The registry lists secondary outcomes of time to disease progression, time to treatment failure, toxicity of the combination, and effects on downstream EGFR targets in skin rash. It does not report numerical results or analyses for these secondary outcomes in the available record. In particular, the record does not give event-time estimates, uncertainty intervals, or a description of censoring. No conclusions about these outcomes can be drawn from their names alone.
Safety information is reported as affected participants and participants at risk for serious and other adverse events, together with death counts. These are descriptive counts in the listed groups. The record does not supply a comparative statistical analysis, establish that events were caused by study treatment, or give timing and follow-up context for the deaths. Serious-event terms and their displayed percentages also require caution because the record does not specify the denominator for each term.
Enrollment was 28. That is the recorded study enrollment, not a basis for reconstructing unreported arm-specific primary-outcome results. General statistical context: estimates from small studies can be imprecise, and the width of a confidence interval communicates uncertainty around an estimate. No confidence intervals for the primary endpoint are reported in the registry record. The most defensible reading is therefore limited: the study design and outcome definitions are documented, but the posted primary efficacy information is insufficient for an estimate of comparative response.
9. Statistical Methods Explained
The study is classified as randomized, parallel, and without masking. These terms describe important parts of design, but they do not supply the missing outcome analysis. Random assignment is intended to reduce systematic differences between groups at entry. A parallel design assigns participants to a treatment approach and follows those groups during the trial rather than switching everyone through each approach. The registry does not report the randomization sequence, allocation ratio, or procedures used to conceal assignment before enrollment.
What does the primary outcome count?
The primary outcome is a count of participants whose tumor status falls into one of three categories: complete response, partial response, or stable disease. This is a categorical outcome based on imaging and the registry's stated RECIST v1.0 criteria. The categories are not interchangeable descriptions: complete response requires disappearance of target lesions, partial response requires a specified decrease in their summed longest diameters, and stable disease does not meet the criteria for either partial response or progression. The record does not provide the category counts, the count grouped into the endpoint, or the number assessed in each arm.
General statistical context: binary or grouped response outcomes can be compared by estimating the proportion meeting the defined outcome in each treatment group and then estimating a contrast between groups. The contrast could be expressed in different ways, each answering a somewhat different question. Its uncertainty is commonly represented by a confidence interval. A confidence interval describes the range of estimates reasonably compatible with the observed data under the method's assumptions; it is not a guarantee that the true effect lies within the interval. No such estimates or intervals are reported for this primary outcome.
Why does assessment timing matter?
The registry specifies imaging at baseline and every 8 weeks during treatment until progressive disease, for a maximum of 51 cycles, with 1 cycle = 2 weeks. Repeated assessments can identify changes over time, while a response category at one assessment may not capture the duration of that status. The outcome description does not give a single assessment date for a primary comparison, nor does it state how category changes across assessments were handled. Those details are not reported in the registry record and should not be inferred from the scheduled imaging interval.
Time to disease progression and time to treatment failure appear among the secondary outcomes. General statistical context: time-to-event methods account for both the observed event time and participants whose event time is not observed during follow-up, using censoring methods. Interpretation depends on the event definition, follow-up, and censoring rules. The registry record does not provide the corresponding analysis details or results, so no time-to-event estimate can be evaluated.
What do the sample-size assumptions mean?
The record describes a planning illustration based on an observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. For time-to-event illustrations, the stated quantity is the total number of events; for other outcomes, it is participants per arm. These are planning assumptions, not a report of the trial's original design justification. The registry record does not report that justification or provide a basis to treat an illustration as observed power. A sample-size calculation is a prospective planning aid; it cannot establish that a study had a particular probability of detecting an effect after results are observed.
General statistical context: a two-sided significance level sets a threshold for considering evidence in either direction under a specified test, while equal allocation is an assumption about how participants are divided between comparison groups. A normal approximation uses a mathematical approximation whose adequacy depends on the setting and data. An assumed fraction of an observed effect is a planning scenario, not a separate clinical finding. None of these assumptions fills in the missing arm-level response counts or comparison.
The registry lists seven outcome measures and zero analyses. That means the record does not include a reported analysis entry to accompany the primary response definition. It does not establish that no analyses were performed outside the registry record. The statistical plan, estimation method, handling of incomplete assessments, and any prespecified contrasts are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven outcome measures, including tumor response, time to disease progression, time to treatment failure, toxicity, and an assessment related to downstream EGFR targets in skin rash. It records zero analyses. Although these outcome names identify several questions, the registry record does not describe a hierarchy among them, identify a single confirmatory contrast beyond labeling the primary outcome, or state whether any adjustment for multiple comparisons was planned. The multiplicity strategy is not reported in the registry record.
General statistical context: testing several outcomes or treatment contrasts can increase the chance of at least one apparently notable result when all are treated as independent opportunities for a finding. A prespecified hierarchy or an adjustment method can address that issue, but neither should be presumed. The record does not provide p-values or results for the primary or secondary outcomes, so the effect of multiplicity on any claim cannot be assessed.
The registry describes an outcome assessment schedule but does not explain how missing scans, unevaluable participants, withdrawal, or incomplete follow-up were handled. The missing-data approach is not reported in the registry record. It also does not identify whether the primary analysis was based on all randomized participants, participants who started treatment, or participants with evaluable imaging. The analysis populations and their definitions are not reported in the registry record.
These omissions matter because a count-based response result depends on both the response classification and the treatment of participants without an evaluable assessment. Different handling rules can change the interpretation of a group estimate. No particular rule should be assumed from the endpoint description alone.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Arm A: Erlotinib + Panitumumab + Irinotecan | 3 | 13 | 23.1% |
| Arm B: Erlotinib + Panitumumab | 4 | 10 | 40.0% |
| Arm C: Erlotinib + Panitumumab | 1 | 2 | 50.0% |
| Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan | 1 | 3 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm A: Erlotinib + Panitumumab + Irinotecan | 11 of 13 |
| Arm B: Erlotinib + Panitumumab | 10 of 10 |
| Arm C: Erlotinib + Panitumumab | 1 of 2 |
| Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan | 3 of 3 |
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 |
|---|---|
| Arm A: Erlotinib + Panitumumab + Irinotecan | 13 of 13 |
| Arm B: Erlotinib + Panitumumab | 10 of 10 |
| Arm C: Erlotinib + Panitumumab | 2 of 2 |
| Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan | 3 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm A: Erlotinib + Panitumumab + Irinotecan | Arm B: Erlotinib + Panitumumab | Arm C: Erlotinib + Panitumumab | Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | 0 of 13 | 0 of 10 | 0 of 2 | 1 of 3 |
| Small bowel obstruction | Gastrointestinal disorders | 1 of 13 | 0 of 10 | 0 of 2 | 0 of 3 |
| Death NOS- progressive disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 13 | 0 of 10 | 0 of 2 | 0 of 3 |
| Gastritis | Gastrointestinal disorders | 0 of 13 | 1 of 10 | 0 of 2 | 0 of 3 |
| Hypoglycemia | Investigations | 0 of 13 | 1 of 10 | 0 of 2 | 0 of 3 |
| Partial Small Bowel Obstruction | Gastrointestinal disorders | 0 of 13 | 1 of 10 | 0 of 2 | 0 of 3 |
| Neutropenic fever | Blood and lymphatic system disorders | 1 of 13 | 0 of 10 | 0 of 2 | 0 of 3 |
| Urinary Track infection | Renal and urinary disorders | 0 of 13 | 0 of 10 | 1 of 2 | 0 of 3 |
| Back pain | Musculoskeletal and connective tissue disorders | 0 of 13 | 0 of 10 | 1 of 2 | 0 of 3 |
| Pneumonia | Infections and infestations | 0 of 13 | 1 of 10 | 0 of 2 | 0 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm A: Erlotinib + Panitumumab + Irinotecan | Arm B: Erlotinib + Panitumumab | Arm C: Erlotinib + Panitumumab | Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan |
|---|---|---|---|---|---|
| Magnesium, serum low (hypomagnesemia) | Metabolism and nutrition disorders | 10 of 13 | 10 of 10 | 2 of 2 | 3 of 3 |
| Acne/acneiform | Skin and subcutaneous tissue disorders | 9 of 13 | 10 of 10 | 1 of 2 | 2 of 3 |
| Hemoglobin (Anemia) | Blood and lymphatic system disorders | 9 of 13 | 8 of 10 | 1 of 2 | 2 of 3 |
| Potassium, serum low (hypokalemia) | Metabolism and nutrition disorders | 10 of 13 | 6 of 10 | 1 of 2 | 3 of 3 |
| AST increase (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | 8 of 13 | 6 of 10 | 2 of 2 | 3 of 3 |
| Diarrhea | Gastrointestinal disorders | 9 of 13 | 5 of 10 | 0 of 2 | 3 of 3 |
| Alkaline phosphatase increase | Metabolism and nutrition disorders | 5 of 13 | 6 of 10 | 2 of 2 | 2 of 3 |
| Fatigue | General disorders | 8 of 13 | 4 of 10 | 0 of 2 | 1 of 3 |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | 8 of 13 | 3 of 10 | 0 of 2 | 2 of 3 |
| Bilirubin increase (hyperbilirubinemia) | Metabolism and nutrition disorders | 6 of 13 | 4 of 10 | 1 of 2 | 2 of 3 |
Serious events with the highest arm-level rate: urinary track infection (50.0%), back pain (50.0%), diarrhea (33.3%), gastritis (10.0%), hypoglycemia (10.0%).
The safety record gives group-level counts for serious adverse events, other adverse events, and deaths. For serious adverse events, it lists 3 affected among 13 at risk in Arm A, 4 among 10 in Arm B, 1 among 2 in Arm C, and 1 among 3 in the Arm B crossover group. For other adverse events, the counts listed are 13 among 13, 10 among 10, 2 among 2, and 3 among 3, respectively. These are descriptive counts, not estimates from a reported comparative analysis.
The death counts are listed as 11 for Arm A, 10 for Arm B, 1 for Arm C, and 3 for the crossover group. The registry record does not report timing, cause, or an attribution of these deaths to treatment. The counts therefore should not be read as establishing treatment causation or as a comparison of mortality between regimens.
Serious adverse event terms include “Urinary Track infection” at 50.0%, “Back pain” at 50.0%, “Diarrhea” at 33.3%, “Gastritis” at 10.0%, “Hypoglycemia” at 10.0%, and “Partial Small Bowel Obstruction” at 10.0%. The record does not state the denominator or group context for each term, so these percentages cannot be confidently translated into group-specific risks. General statistical context: an adverse-event percentage is interpretable only with a clear event definition, denominator, and observation period. The registry record does not provide all of that context for these terms.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized phase II study evaluated erlotinib and panitumumab with or without irinotecan as second-line therapy for metastatic colorectal cancer. It documents treatment descriptions, imaging-based response criteria, a scheduled assessment interval, secondary outcome names, and selected safety counts. Those details help define what the study set out to examine.
What the record does not establish is the primary response result. It contains no arm-specific counts for complete response, partial response, or stable disease and no statistical estimate comparing the treatment approaches. It therefore cannot show the size or direction of a response contrast, its precision, or whether the data are compatible with a range of effects. Lack of a reported result should not be mistaken for a finding of no difference.
The endpoint itself combines three disease-status categories. General statistical context: a combined outcome can make a result easier to summarize, but it can also conceal variation among its component categories. Without the separate counts, it is not possible to tell how much of any combined result would reflect tumor disappearance, shrinkage, or stable disease. The record also does not report how response categories changed across assessments.
Safety counts describe events recorded in the listed groups, but do not by themselves establish whether treatment caused an event or whether one regimen had a different risk. The registry does not supply the timing and attribution information needed for those conclusions. Nor do the listed deaths provide a treatment comparison without relevant follow-up and analysis details.
Accordingly, the defensible interpretation is about the scope of the record rather than an efficacy conclusion: the design and outcome definitions are available, while the posted primary response analysis is not. Any broader claim about comparative benefit, harm, or clinical use would go beyond the information reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why a statistical reading separates study design, outcome definition, and outcome results. Randomization describes how treatment assignment was intended to occur; it does not substitute for arm-level data. A precise endpoint definition tells readers what would count as a response, but it cannot show how many participants met that definition. In this record, those design and measurement details are available while the primary response analysis is not.
The response endpoint also illustrates a common interpretive issue: a combined category can bring different states together. Complete response, partial response, and stable disease are defined separately, yet the endpoint groups them. Without the component counts, a reader cannot see which category contributes to the combined measure. This makes reporting the endpoint definition and its component results important for understanding what a summary represents.
The study has multiple listed outcomes and three described arms, including two arms whose regimen descriptions overlap. The record does not clarify the distinction between Arms B and C or report the planned statistical contrasts. This underlines why a complete analysis plan should make comparisons, analysis populations, and outcome handling clear. Since those details are not reported in the registry record, they should not be reconstructed from the labels.
Finally, the safety figures show why denominators and context matter. A count, a percentage, and a causal interpretation are different kinds of information. The record provides selected counts and some percentages but does not give all term-specific denominators or event attribution. Reading those figures as descriptive rather than causal respects what they can support without extending beyond the documented evidence.
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.
Several limitations specific to this record restrict interpretation. Although enrollment is recorded as 28, primary response counts and arm-level estimates are not reported. Without those results, neither the magnitude nor precision of the primary treatment comparison can be assessed. The registry also records zero analyses, so there is no reported inferential analysis to evaluate alongside the response definition.
Three arms are described, but Arm B and Arm C are both characterized as erlotinib plus panitumumab, and the record does not explain their distinction. Arm B is described as receiving irinotecan after progression; Arm C is described by reference to Arm B's regimen. A separate crossover safety group is listed, but the registry does not provide enough detail to reconstruct how it relates to the randomized groups. No allocation proportions or randomization procedures are reported.
The primary endpoint combines complete response, partial response, and stable disease, but no component counts are available. The record gives an imaging schedule and RECIST v1.0 definitions without stating the assessment used for the primary comparison, how missing or unevaluable imaging was handled, or which participants were included in the analysis. Those details are not reported in the registry record.
The study is open-label, and the registry does not say whether imaging review was blinded. Secondary outcomes are named but their results and analysis methods are not reported. Safety information lacks context on event timing and attribution, and the denominator for each listed serious-event term is not specified. These gaps limit both comparative efficacy interpretation and safety interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer — NCT00940316.
- Registry record last updated 2019-05-07; status last verified 2019-04.
- Results first posted 2019-05-07.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT00940316 is a completed randomized, open-label, parallel phase II study sponsored by Northwestern University. The registry records enrollment of 28, a start date of 2010-01-18, and primary completion in 2015-01. It evaluates erlotinib and panitumumab with or without irinotecan as second-line therapy for metastatic colorectal cancer.
The primary outcome is a participant count based on complete response, partial response, or stable disease under RECIST v1.0, with imaging scheduled at baseline and every 8 weeks during treatment. The registry also lists outcomes concerning disease progression, treatment failure, toxicity, and downstream EGFR targets in skin rash. It records seven outcome measures and zero analyses.
Arm-specific primary response results and a statistical comparison are not reported in the registry record. The available safety entries are descriptive counts and do not establish treatment causation. Consequently, the record documents the study design and measurement approach, but does not support a conclusion about comparative response.