Comparison · NCT00468169-e134da11
A: Cetuximab+FHX vs B: Cetuximab + PX: Residual Lymph Node Disease
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. A: Cetuximab+FHX vs B: Cetuximab + PX: Residual Lymph Node Disease. Trial comparisons, record NCT00468169-e134da11. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00468169-e134da11
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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 | 0.0351 | 0.00968 | 0.119 | wilson | |
| Risk in group 2 | 0.113 | 0.0529 | 0.226 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0781 | -0.194 | 0.0254 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.31 | 0.0654 | 1.47 | log | |
| Odds ratio, group 1 over group 2 | 0.285 | 0.0549 | 1.48 | log | |
| Number needed to treat, for one fewer participant with the outcome on A: Cetuximab+FHX than on B: Cetuximab + PX | 12.8 | 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 | A: Cetuximab+FHX | Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.~Cetuximab: 250mg/m2(day 1, weekly x 10);~5-FU: 600 mg/m2/day; days 0-5 (120 h total) every other week x 5~Hydroxyurea: 500 mg PO BID, days 0-5 every other week x 5~Twice-daily radiation: 150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks) | 2 | 57 | OG000 |
| Group 2 | B: Cetuximab + PX | Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.~Cetuximab: 250mg/m2(day 1, weekly x 10);~Cisplatin: 100 mg/m2, week 1 and 4 on day 1 (or 2)~Accelerated fraction radiotherapy with concomitant boost: 72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks. | 6 | 53 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Residual Lymph Node Disease
- Description
Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (\>1.5 cm) or focally abnormal lymph node.
- Time frame
- Up to 10 weeks
- Population
Source ClinicalTrials.gov
Trial
- Title
- Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
- NCT number
- NCT00468169
- Phases
- PHASE2
- Conditions
- Head and Neck Cancer
- Interventions
- Cetuximab, 5-FU, Hydroxyurea, Twice-daily radiation, Cisplatin, Accelerated fraction radiotherapy with concomitant boost
- Lead sponsor
- University of Chicago
- Results first posted
- 2019-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00468169?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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