TriangleNCT03258554 · OUTCOME
Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary]
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: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.
What was measured
Progression (failure) is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure or last follow-up (censored). Failure rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided. Analysis was planned to occur after 69 failure events had been reported.
Analysis population: Randomized participants
Groups in this outcome
RT + Cetuximab
IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
RT + Durvalumab
IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| RT + Cetuximab | 63 |
| RT + Durvalumab | 123 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RT + Cetuximab | 63.7 | Not reported | 51.3 | 76.1 | Not reported |
| RT + Durvalumab | 50.6 | Not reported | 41.5 | 59.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.12
- estimate Comment
- Reference arm = radiation therapy + cetuximab
- group Description
- Sixty-nine progression-free survival (PFS) events provides 0.80 power for a log-rank test with one-sided alpha of 0.20 to detect an improvement in PFS corresponding to a median of 2.35 years (RT+Durvalumab) compared to 1.53 years (RT+Cetuximab). A hazard ratio (RT+Durvalumab/RT+Cetuximab) ≤ 0.806 would indicate a rejection of the null hypothesis (no difference between the arms) and the study would continue to phase III; otherwise, the study would not continue to phase III.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8878
- p Value Comment
- One-sided significance level = 0.2
- param Type
- Hazard Ratio (HR)
- param Value
- 1.33
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.12
- estimate Comment
- Reference arm = radiation therapy + cetuximab
- group Description
- Sixty-nine progression-free survival (PFS) events provides 0.80 power for a log-rank test with one-sided alpha of 0.20 to detect an improvement in PFS corresponding to a median of 2.35 years (RT+Durvalumab) compared to 1.53 years (RT+Cetuximab). A hazard ratio (RT+Durvalumab/RT+Cetuximab) ≤ 0.806 would indicate a rejection of the null hypothesis (no difference between the arms) and the study would continue to phase III; otherwise, the study would not continue to phase III.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8878
- p Value Comment
- One-sided significance level = 0.2
- param Type
- Hazard Ratio (HR)
- param Value
- 1.33
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.3
- upper Limit
- 76.1
- value
- 63.7
- group Id
- OG001
- lower Limit
- 41.5
- upper Limit
- 59.8
- value
- 50.6
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 123
- units
- Participants
- description
- Progression (failure) is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure or last follow-up (censored). Failure rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided. Analysis was planned to occur after 69 failure events had been reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- RT + Cetuximab
- description
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- RT + Durvalumab
- param Type
- NUMBER
- population Description
- Randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.
- title
- Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary]
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice