TriangleNCT01064479 · OUTCOME
Progression Free Survival (PFS)
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
- 5 years
What was measured
Kaplan-Meier methods will be used to summarize PFS. In the primary analysis, differences in PFS in Arm A versus Arm B will be tested using a stratified log-rank test with a two-sided alpha of 0.10. Hazard ratios for PFS will be presented using point estimates and 95% confidence intervals.
Groups in this outcome
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
Arm B (Combination Chemotherapy and Placebo)
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
| Group | Source count |
|---|---|
| Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | 60 |
| Arm B (Combination Chemotherapy and Placebo) | 59 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | 6.08 | Not reported | 5.45 | 7.52 | Not reported |
| Arm B (Combination Chemotherapy and Placebo) | 4.4 | Not reported | 3.45 | 5.78 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.45
- upper Limit
- 7.52
- value
- 6.08
- group Id
- OG001
- lower Limit
- 3.45
- upper Limit
- 5.78
- value
- 4.4
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 59
- units
- Participants
- description
- Kaplan-Meier methods will be used to summarize PFS. In the primary analysis, differences in PFS in Arm A versus Arm B will be tested using a stratified log-rank test with a two-sided alpha of 0.10. Hazard ratios for PFS will be presented using point estimates and 95% confidence intervals.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
- id
- OG000
- title
- Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
- description
- Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
- id
- OG001
- title
- Arm B (Combination Chemotherapy and Placebo)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- 5 years
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice