TriangleNCT00064077 · OUTCOME
Duration of 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
- Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
What was measured
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Analysis population: Evaluable (treatment)
Groups in this outcome
Arm I (Paclitaxel, Cisplatin)
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
Arm II (Vinorelbine, Cisplatin)
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV
Arm III (Gemcitabine, Cisplatin)
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies
Arm IV (Topotecan, Cisplatin)
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
| Group | Source count |
|---|---|
| Arm I (Paclitaxel, Cisplatin) | 103 |
| Arm II (Vinorelbine, Cisplatin) | 108 |
| Arm III (Gemcitabine, Cisplatin) | 112 |
| Arm IV (Topotecan, Cisplatin) | 111 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | 5.82 | Not reported | 4.53 | 7.59 | Not reported |
| Arm II (Vinorelbine, Cisplatin) | 3.98 | Not reported | 3.19 | 5.16 | Not reported |
| Arm III (Gemcitabine, Cisplatin) | 4.70 | Not reported | 3.58 | 5.59 | Not reported |
| Arm IV (Topotecan, Cisplatin) | 4.57 | Not reported | 3.71 | 5.75 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.53
- upper Limit
- 7.59
- value
- 5.82
- group Id
- OG001
- lower Limit
- 3.19
- upper Limit
- 5.16
- value
- 3.98
- group Id
- OG002
- lower Limit
- 3.58
- upper Limit
- 5.59
- value
- 4.70
- group Id
- OG003
- lower Limit
- 3.71
- upper Limit
- 5.75
- value
- 4.57
- denoms
- counts
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 108
- group Id
- OG002
- value
- 112
- group Id
- OG003
- value
- 111
- units
- Participants
- description
- Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
- id
- OG000
- title
- Arm I (Paclitaxel, Cisplatin)
- description
- Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV
- id
- OG001
- title
- Arm II (Vinorelbine, Cisplatin)
- description
- Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies
- id
- OG002
- title
- Arm III (Gemcitabine, Cisplatin)
- description
- Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
- id
- OG003
- title
- Arm IV (Topotecan, Cisplatin)
- param Type
- MEDIAN
- population Description
- Evaluable (treatment)
- reporting Status
- POSTED
- time Frame
- Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
- title
- Duration of Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice