TriangleNCT01256385 · OUTCOME
PFS vs. Historical Control Cohort
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
- 90% Confidence Interval
- Time frame
- From start of treatment to time of progression or death of any cause, assessed at 4 months
What was measured
PFS at 4 months in Arm A and Arm B will each be compared with a 4-month historical control rate of 21.4%. The historical data appears in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568 and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343.
Analysis population: Note: Each arm is separately compared to an historical rate of 21.4%, based on a one-sided test at the 0.05 significant level. Since the 90% CIs each exclude 21.4%, the 4-month PFS rate in both arms exceeds the fixed historical control rate.
Groups in this outcome
Arm A (Cetuximab and Temsirolimus)
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Arm B (Temsirolimus)
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
| Group | Source count |
|---|---|
| Arm A (Cetuximab and Temsirolimus) | 40 |
| Arm B (Temsirolimus) | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Cetuximab and Temsirolimus) | 41.3 | Not reported | 28.3 | 54.3 | Not reported |
| Arm B (Temsirolimus) | 36.4 | Not reported | 22.6 | 50.2 | Not reported |
Source statistical analyses
- group Description
- PFS at 4 months in Arm A was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.006
- statistical Method
- Chi-squared
- group Description
- PFS at 4 months in Arm B was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.037
- p Value Comment
- 1-sided.
- statistical Method
- Chi-squared
Complete source fields
- analyses
- group Description
- PFS at 4 months in Arm A was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.006
- statistical Method
- Chi-squared
- group Description
- PFS at 4 months in Arm B was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.037
- p Value Comment
- 1-sided.
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.3
- upper Limit
- 54.3
- value
- 41.3
- group Id
- OG001
- lower Limit
- 22.6
- upper Limit
- 50.2
- value
- 36.4
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- PFS at 4 months in Arm A and Arm B will each be compared with a 4-month historical control rate of 21.4%. The historical data appears in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568 and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A (Cetuximab and Temsirolimus)
- description
- Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
- id
- OG001
- title
- Arm B (Temsirolimus)
- param Type
- NUMBER
- population Description
- Note: Each arm is separately compared to an historical rate of 21.4%, based on a one-sided test at the 0.05 significant level. Since the 90% CIs each exclude 21.4%, the 4-month PFS rate in both arms exceeds the fixed historical control rate.
- reporting Status
- POSTED
- time Frame
- From start of treatment to time of progression or death of any cause, assessed at 4 months
- title
- PFS vs. Historical Control Cohort
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice