TriangleNCT00104676 · OUTCOME
Progression-free Survival Rate After 1 Course of Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 3 years from randomization
What was measured
Primary objective is to compare the progression-free survival of participants after 1 cycle of treatment, treated randomly by 3 additional cycles of BEP (Arm I) or by T-BEP-Oxaliplatin/cisplatin-ifosfamide-Bleomycin (Arm II). The median progression-free survival rate was defined as the median percentage of participants alive without disease progression after 1 course of treatment.
Analysis population: The primary endpoint for the study was the comparison of the PFS rates in the population of participants with a poor prognostic non-seminomatous germ cell tumors and with an unfavorable decrease in tumor biomarkers, randomized to either Unfav-BEP Control Arm (Arm I) or Unfav-Dose-Dense Arm (Arm II).
Groups in this outcome
Arm I
Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered
Arm II
Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered ifosfamide: Given in a dose-dense sequential fashion oxaliplatin: Given in a dose-dense sequential fashion paclitaxel: Given in a dose-dense sequential fashion
| Group | Source count |
|---|---|
| Arm I | 98 |
| Arm II | 105 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I | 48 | Not reported | 38 | 59 | Not reported |
| Arm II | 59 | Not reported | 49 | 68 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.00
- group Description
- To detect an absolute difference of 20% in progression-free survival at 3-years between Arm I and Unfav-Dose-Dense Arm II (46% versus 66%) with the possibility that 80 events (progressive disease and death) may be observed during this period, a total of 196 participants, 98 per group needed to be included, with an additional 25% of patients for a total of 260 participants required.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.05
- param Type
- Hazard Ratio (HR)
- param Value
- 0.66
- statistical Comment
- Adjusted on the stratification factor (treatment centers)
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.00
- group Description
- To detect an absolute difference of 20% in progression-free survival at 3-years between Arm I and Unfav-Dose-Dense Arm II (46% versus 66%) with the possibility that 80 events (progressive disease and death) may be observed during this period, a total of 196 participants, 98 per group needed to be included, with an additional 25% of patients for a total of 260 participants required.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.05
- param Type
- Hazard Ratio (HR)
- param Value
- 0.66
- statistical Comment
- Adjusted on the stratification factor (treatment centers)
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38
- upper Limit
- 59
- value
- 48
- group Id
- OG001
- lower Limit
- 49
- upper Limit
- 68
- value
- 59
- denoms
- counts
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 105
- units
- Participants
- description
- Primary objective is to compare the progression-free survival of participants after 1 cycle of treatment, treated randomly by 3 additional cycles of BEP (Arm I) or by T-BEP-Oxaliplatin/cisplatin-ifosfamide-Bleomycin (Arm II). The median progression-free survival rate was defined as the median percentage of participants alive without disease progression after 1 course of treatment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered
- id
- OG000
- title
- Arm I
- description
- Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered ifosfamide: Given in a dose-dense sequential fashion oxaliplatin: Given in a dose-dense sequential fashion paclitaxel: Given in a dose-dense sequential fashion
- id
- OG001
- title
- Arm II
- param Type
- NUMBER
- population Description
- The primary endpoint for the study was the comparison of the PFS rates in the population of participants with a poor prognostic non-seminomatous germ cell tumors and with an unfavorable decrease in tumor biomarkers, randomized to either Unfav-BEP Control Arm (Arm I) or Unfav-Dose-Dense Arm (Arm II).
- reporting Status
- POSTED
- time Frame
- 3 years from randomization
- title
- Progression-free Survival Rate After 1 Course of Treatment
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice