Comparison · NCT03095248-38fcb07f
Stratum 1: NF2 Tumor (Vestibular Schwanomas) vs Stratum 2- NF2 Tumors (Non-vestibular Schwanoma (VS)): Radiographic Tumor Response
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Stratum 1: NF2 Tumor (Vestibular Schwanomas) vs Stratum 2- NF2 Tumors (Non-vestibular Schwanoma (VS)): Radiographic Tumor Response. Trial comparisons, record NCT03095248-38fcb07f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03095248-38fcb07f
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.207 | 1 | wilson | |
| Risk in group 2 | 1 | 0.701 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.793 | 0.299 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Stratum 1: NF2 Tumor (Vestibular Schwanomas) | Response and progression for vestibular schwannomas will be evaluated in this study using the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) criteria. Response and progression for stratum 1 will not be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) or by MacDonald Criteria, since they may underestimate progression in these irregularly shaped tumors. However, linear measurements utilizing RECIST will be collected as part of the trial for comparison with volumetric measurements. Linear measurements utilizing RECIST will be used for non-target lesions on stratum 1.~REiNS criteria for target lesions:~Radiographic Response (RR) At least a 20% decrease in the volume of the target lesions, taking as reference the baseline volume.~Progressive Disease (PD) At least a 20% increase in the volume of the target lesion, taking as reference the lower volume during treatment Stable Disease (SD) Does not meet criteria for radiographic response or for progressive disease.~Non-target lesions (RECIST criteria) Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level~Incomplete Response/ Stable Disease (SD): Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits~Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions | 1 | 1 | OG000 |
| Group 2 | Stratum 2- NF2 Tumors (Non-vestibular Schwanoma (VS)) | Stratum 2 Response and progression for non-VS tumor by MacDonald Criteria as measured by Complete responses, partial response, stable disease or progressive disease. | 9 | 9 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Radiographic Tumor Response
- Description
- To determine the radiographic response rate for Stratum 1 and Stratum 2. Specifics for each stratum are defined in the Arms/ Groups.
- Time frame
- Through study completion up to 2 years
- Population
Source ClinicalTrials.gov
Trial
- Title
- Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors
- NCT number
- NCT03095248
- Phases
- PHASE2
- Conditions
- Neurofibromatosis 2, Vestibular Schwannoma, Meningioma, Ependymoma, Glioma
- Interventions
- Selumetinib
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Results first posted
- 2025-04-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03095248?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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