TriangleNCT01013649 · OUTCOME
Overall Survival (Percentage of Participants Alive) [Phase II]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.
What was measured
Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from step 1 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur after 200 deaths were reported.
Analysis population: Eligible participants randomized at step 1.
Groups in this outcome
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)
Patients receive either gemcitabine hydrochloride or \[starting 6-28-2016\] allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)
\[Closed to accrual 2-28-14.\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
| Group | Source count |
|---|---|
| Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 163 |
| Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 159 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy) | 29.9 | Not reported | 21.7 | 33.4 | Not reported |
| Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 28.1 | Not reported | 20.7 | 30.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.38
- estimate Comment
- Reference level = Arm I
- group Description
- A total of 200 deaths between the arms will provide 80% power to detect a signal for an increase in median overall survival from 22 to 28.8 months and 90% power to detect a signal for an increase in median overall survival from 22 to 30.6 months (HRs of 0.76 and 0.72, respectively, in favor of the erlotinib arm) with the addition of erlotinib and a 1-sided alpha of 0.15
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.62
- p Value Comment
- One-sided significance level = 0.15
- param Type
- Hazard Ratio (HR)
- param Value
- 1.04
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.38
- estimate Comment
- Reference level = Arm I
- group Description
- A total of 200 deaths between the arms will provide 80% power to detect a signal for an increase in median overall survival from 22 to 28.8 months and 90% power to detect a signal for an increase in median overall survival from 22 to 30.6 months (HRs of 0.76 and 0.72, respectively, in favor of the erlotinib arm) with the addition of erlotinib and a 1-sided alpha of 0.15
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.62
- p Value Comment
- One-sided significance level = 0.15
- param Type
- Hazard Ratio (HR)
- param Value
- 1.04
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21.7
- upper Limit
- 33.4
- value
- 29.9
- group Id
- OG001
- lower Limit
- 20.7
- upper Limit
- 30.9
- value
- 28.1
- denoms
- counts
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 159
- units
- Participants
- description
- Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from step 1 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur after 200 deaths were reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive either gemcitabine hydrochloride or \[starting 6-28-2016\] allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
- id
- OG000
- title
- Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)
- description
- \[Closed to accrual 2-28-14.\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
- id
- OG001
- title
- Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)
- param Type
- MEDIAN
- population Description
- Eligible participants randomized at step 1.
- reporting Status
- POSTED
- time Frame
- From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.
- title
- Overall Survival (Percentage of Participants Alive) [Phase II]
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice