TriangleNCT00084318 · OUTCOME
Local-regional Control
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to 2 years
What was measured
Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).
Analysis population: Eligible patients who started protocol treatment and did not withdraw consent.
Groups in this outcome
RT + Cisplatin + Cetuximab
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
RT + Docetaxel + Cetuximab
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
| Group | Source count |
|---|---|
| RT + Cisplatin + Cetuximab | 97 |
| RT + Docetaxel + Cetuximab | 106 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RT + Cisplatin + Cetuximab | 19.8 | Not reported | 11.8 | 27.8 | Not reported |
| RT + Docetaxel + Cetuximab | 18.9 | Not reported | 13.4 | 24.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.76
- estimate Comment
- Reference arm = historical control
- group Description
- Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.66
- param Type
- Hazard Ratio (HR)
- param Value
- 1.05
- statistical Comment
- Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)
- statistical Method
- Gray's test
- ci Lower Limit
- 0.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.87
- estimate Comment
- Reference arm = historical control
- group Description
- Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model.
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.86
- param Type
- Hazard Ratio (HR)
- param Value
- 1.16
- statistical Comment
- Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)
- statistical Method
- Gray's test
Complete source fields
- analyses
- ci Lower Limit
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.76
- estimate Comment
- Reference arm = historical control
- group Description
- Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.66
- param Type
- Hazard Ratio (HR)
- param Value
- 1.05
- statistical Comment
- Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)
- statistical Method
- Gray's test
- ci Lower Limit
- 0.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.87
- estimate Comment
- Reference arm = historical control
- group Description
- Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model.
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.86
- param Type
- Hazard Ratio (HR)
- param Value
- 1.16
- statistical Comment
- Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)
- statistical Method
- Gray's test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.8
- upper Limit
- 27.8
- value
- 19.8
- group Id
- OG001
- lower Limit
- 13.4
- upper Limit
- 24.3
- value
- 18.9
- denoms
- counts
- group Id
- OG000
- value
- 97
- group Id
- OG001
- value
- 106
- units
- Participants
- description
- Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
- id
- OG000
- title
- RT + Cisplatin + Cetuximab
- description
- Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
- id
- OG001
- title
- RT + Docetaxel + Cetuximab
- param Type
- NUMBER
- population Description
- Eligible patients who started protocol treatment and did not withdraw consent.
- reporting Status
- POSTED
- time Frame
- From randomization to 2 years
- title
- Local-regional Control
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice