TriangleNCT01064648 · OUTCOME
Progression-free Survival (Phase II)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- month
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever came first, assessed up to 5 years.Disease assessment will be repeated every 6 weeks until disease progression.
What was measured
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesions, or the appearance of new lesions.
Analysis population: Only eligible and analyzable patients were included.
Groups in this outcome
Phase II Cisplatin-pemetrexed Cediranib 20mg
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
Phase II Cisplatin-pemetrexed Placebo
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
| Group | Source count |
|---|---|
| Phase II Cisplatin-pemetrexed Cediranib 20mg | 45 |
| Phase II Cisplatin-pemetrexed Placebo | 47 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Cisplatin-pemetrexed Cediranib 20mg | 7.2 | Not reported | 5.5 | 8.5 | Not reported |
| Phase II Cisplatin-pemetrexed Placebo | 5.6 | Not reported | 4.6 | 6.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 80
- ci Upper Limit
- 0.95
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.06
- p Value Comment
- 1-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.71
- statistical Comment
- Stratified log rank test by performance status and histology type.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 80
- ci Upper Limit
- 0.95
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.06
- p Value Comment
- 1-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.71
- statistical Comment
- Stratified log rank test by performance status and histology type.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 8.5
- value
- 7.2
- group Id
- OG001
- lower Limit
- 4.6
- upper Limit
- 6.2
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 47
- units
- Participants
- description
- From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesions, or the appearance of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
- id
- OG000
- title
- Phase II Cisplatin-pemetrexed Cediranib 20mg
- description
- Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
- id
- OG001
- title
- Phase II Cisplatin-pemetrexed Placebo
- param Type
- MEDIAN
- population Description
- Only eligible and analyzable patients were included.
- reporting Status
- POSTED
- time Frame
- From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever came first, assessed up to 5 years.Disease assessment will be repeated every 6 weeks until disease progression.
- title
- Progression-free Survival (Phase II)
- type
- PRIMARY
- unit Of Measure
- month
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Preserved source evidence · Not medical advice