TriangleNCT01064648 · OUTCOME
Disease Control Rate by Modified RECIST (Phase II)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of analyzed participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Disease control is documented for as long as the patient remains on protocol treatment.
What was measured
Per modified RECIST for Pleural Tumors. In addition to RECIST1.1, for modified RECIST, measurements based on the sum of 6 CT cuts in the pleural perpendicular to the chest wall are applied to standard RECIST criterial (sum of 6 = one univariate diameter). Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (STA), does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA. All target measurable lesions must be assessed using the same techniques as baseline.
Analysis population: Eligible patients with baseline measurable disease per modified RECIST were included in the analysis.
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 | 36 |
| Phase II Cisplatin-pemetrexed Placebo | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Cisplatin-pemetrexed Cediranib 20mg | 75 | Not reported | 58 | 88 | Not reported |
| Phase II Cisplatin-pemetrexed Placebo | 83 | Not reported | 65 | 94 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.94
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.19
- p Value Comment
- 1-sided p-value
- param Type
- Odds Ratio (OR)
- param Value
- 0.59
- statistical Comment
- Stratified Chi-Square by performance status and histology
- statistical Method
- Chi-squared
Complete source fields
- analyses
- ci Lower Limit
- 0.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.94
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.19
- p Value Comment
- 1-sided p-value
- param Type
- Odds Ratio (OR)
- param Value
- 0.59
- statistical Comment
- Stratified Chi-Square by performance status and histology
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 58
- upper Limit
- 88
- value
- 75
- group Id
- OG001
- lower Limit
- 65
- upper Limit
- 94
- value
- 83
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 30
- units
- Participants
- description
- Per modified RECIST for Pleural Tumors. In addition to RECIST1.1, for modified RECIST, measurements based on the sum of 6 CT cuts in the pleural perpendicular to the chest wall are applied to standard RECIST criterial (sum of 6 = one univariate diameter). Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (STA), does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA. All target measurable lesions must be assessed using the same techniques as baseline.
- 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
- NUMBER
- population Description
- Eligible patients with baseline measurable disease per modified RECIST were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Disease control is documented for as long as the patient remains on protocol treatment.
- title
- Disease Control Rate by Modified RECIST (Phase II)
- type
- SECONDARY
- unit Of Measure
- percentage of analyzed participants
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Preserved source evidence · Not medical advice