TriangleNCT01302834 · OUTCOME
Time to Local-regional Failure
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 last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
What was measured
Failure for local-regional failure endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of local-regional failure times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Analysis population: Eligible participants
Groups in this outcome
IMRT + Cisplatin
Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
IMRT + Cetuximab
Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
| Group | Source count |
|---|---|
| IMRT + Cisplatin | 406 |
| IMRT + Cetuximab | 399 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IMRT + Cisplatin | 9.9 | Not reported | 6.9 | 13.6 | Not reported |
| IMRT + Cetuximab | 17.3 | Not reported | 13.7 | 21.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.35
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.10
- estimate Comment
- Reference level = IMRT + Cisplatin
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0005
- param Type
- Hazard Ratio (HR)
- param Value
- 2.05
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 1.35
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.10
- estimate Comment
- Reference level = IMRT + Cisplatin
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0005
- param Type
- Hazard Ratio (HR)
- param Value
- 2.05
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.9
- upper Limit
- 13.6
- value
- 9.9
- group Id
- OG001
- lower Limit
- 13.7
- upper Limit
- 21.4
- value
- 17.3
- denoms
- counts
- group Id
- OG000
- value
- 406
- group Id
- OG001
- value
- 399
- units
- Participants
- description
- Failure for local-regional failure endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of local-regional failure times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
- id
- OG000
- title
- IMRT + Cisplatin
- description
- Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
- id
- OG001
- title
- IMRT + Cetuximab
- param Type
- NUMBER
- population Description
- Eligible participants
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
- title
- Time to Local-regional Failure
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice