TriangleNCT00002597 · OUTCOME
Overall Survival Rate (10-year)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization to 10 years
What was measured
Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan-Meier method.
Analysis population: All eligible patients.
Groups in this outcome
Hormone Therapy + Radiation Therapy
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
Radiation Therapy Alone
Radiation therapy alone
| Group | Source count |
|---|---|
| Hormone Therapy + Radiation Therapy | 987 |
| Radiation Therapy Alone | 992 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Hormone Therapy + Radiation Therapy | 61.9 | Not reported | 58.3 | 65.3 | Not reported |
| Radiation Therapy Alone | 56.8 | Not reported | 53.2 | 60.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.35
- estimate Comment
- Reference level = Hormone Therapy + Radiation Therapy
- group Description
- Null hypothesis: 8-year OS rate of 60% radiation therapy (RT) alone vs. 67% with hormone therapy. The study was designed with 90% power to detect a 7-percentage- point absolute difference in the 8-year survival rate, with the use of a one-sided log-rank test at the 0.025 significance level, requiring 1980 patients and 716 deaths for definitive analysis.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0309
- param Type
- Hazard Ratio (HR)
- param Value
- 1.17
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 1.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.35
- estimate Comment
- Reference level = Hormone Therapy + Radiation Therapy
- group Description
- Null hypothesis: 8-year OS rate of 60% radiation therapy (RT) alone vs. 67% with hormone therapy. The study was designed with 90% power to detect a 7-percentage- point absolute difference in the 8-year survival rate, with the use of a one-sided log-rank test at the 0.025 significance level, requiring 1980 patients and 716 deaths for definitive analysis.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0309
- param Type
- Hazard Ratio (HR)
- param Value
- 1.17
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 58.3
- upper Limit
- 65.3
- value
- 61.9
- group Id
- OG001
- lower Limit
- 53.2
- upper Limit
- 60.2
- value
- 56.8
- denoms
- counts
- group Id
- OG000
- value
- 987
- group Id
- OG001
- value
- 992
- units
- Participants
- description
- Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
- id
- OG000
- title
- Hormone Therapy + Radiation Therapy
- description
- Radiation therapy alone
- id
- OG001
- title
- Radiation Therapy Alone
- param Type
- NUMBER
- population Description
- All eligible patients.
- reporting Status
- POSTED
- time Frame
- From date of randomization to 10 years
- title
- Overall Survival Rate (10-year)
- type
- PRIMARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice