Comparison · NCT02369458-e110f721
Cohort A: p16+ OPSCC vs Cohort B: p16- HNSCC: Tumor Response Rate (TRR)
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. Cohort A: p16+ OPSCC vs Cohort B: p16- HNSCC: Tumor Response Rate (TRR). Trial comparisons, record NCT02369458-e110f721. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02369458-e110f721
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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 | 0.0909 | 0.0314 | 0.236 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.242 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0909 | -0.159 | 0.236 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Cohort A: p16+ OPSCC than on Cohort B: p16- HNSCC | 11 | from the risk difference interval | the interval includes no difference |
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 | Cohort A: p16+ OPSCC | * Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).~* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection) | 3 | 33 | OG000 |
| Group 2 | Cohort B: p16- HNSCC | * Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).~* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection) | 0 | 12 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Tumor Response Rate (TRR)
- Description
* TRR will be evaluated separately in p16- (HPV-unrelated) HNSCC patients and in p16+ (HPV positive) OPSCC patients using two optimal two-stage Simon designs. In both cases, the expected TRR is 10%. A TRR of 30% is considered a clinically significant increase.~* RECIST 1.1 will be used for this outcome.
- Time frame
- Approximately 6 months (median 5.6 months with full range of 0.1-33.7 months)
- Population
- One participant in each arm were not evaluable for tumor response rate.
Source ClinicalTrials.gov
Trial
- Title
- Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies
- NCT number
- NCT02369458
- Phases
- PHASE2
- Conditions
- Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Head and Neck
- Interventions
- Mitomycin-C, Pegfilgrastim
- Lead sponsor
- Washington University School of Medicine
- Results first posted
- 2023-05-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02369458?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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