TriangleNCT01013649 · OUTCOME
Disease-free Survival (Percentage of Participants Alive Without Disease) [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 step1 randomization (gemcitabine vs. gemcitabine/erlotinib) to disease event, death, or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Five-year rates are reported here.
What was measured
Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 1 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to 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 \[starting 06-28-2016\] 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)
\[Closed to accrual 2-28-2014.\] 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) | 12.7 | Not reported | 10.8 | 15.7 | Not reported |
| Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride) | 12.4 | Not reported | 9.7 | 16.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.80
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.31
- estimate Comment
- Reference level = Arm I
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.02
Complete source fields
- analyses
- ci Lower Limit
- 0.80
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.31
- estimate Comment
- Reference level = Arm I
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.02
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.8
- upper Limit
- 15.7
- value
- 12.7
- group Id
- OG001
- lower Limit
- 9.7
- upper Limit
- 16.5
- value
- 12.4
- denoms
- counts
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 159
- units
- Participants
- description
- Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 1 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to 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 \[starting 06-28-2016\] 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
- \[Closed to accrual 2-28-2014.\] 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 step1 randomization (gemcitabine vs. gemcitabine/erlotinib) to disease event, death, or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Five-year rates are reported here.
- title
- Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II]
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice