TriangleNCT01196390 · OUTCOME
Disease-free Survival (DFS)
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
- From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.
What was measured
A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported.
Analysis population: Eligible randomized participants
Groups in this outcome
Chemoradiation and Trastuzumab (Arm 1)
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
Chemoradiation (Arm 2)
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
| Group | Source count |
|---|---|
| Chemoradiation and Trastuzumab (Arm 1) | 98 |
| Chemoradiation (Arm 2) | 96 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemoradiation and Trastuzumab (Arm 1) | 19.6 | Not reported | 13.5 | 26.2 | Not reported |
| Chemoradiation (Arm 2) | 14.2 | Not reported | 10.5 | 23.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.69
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.36
- estimate Comment
- Reference level = Chemoradiation arm
- group Description
- Assuming a median DFS time of 15 months (Arm 2), hypothesized increase in DFS corresponding to median DFS time of 25 months (Arm 1). Assuming an exponential distribution and constant hazards, 183 HER2-positive participants accrued over 5 years and followed for 3 years would result in 162 disease-free survival events and provide 90% statistical power to detect this difference with a 2-sided α of 0.05 and 2 interim analyses. See Limitations and Caveats section.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.85
- param Type
- Hazard Ratio (HR)
- param Value
- 0.97
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.69
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.36
- estimate Comment
- Reference level = Chemoradiation arm
- group Description
- Assuming a median DFS time of 15 months (Arm 2), hypothesized increase in DFS corresponding to median DFS time of 25 months (Arm 1). Assuming an exponential distribution and constant hazards, 183 HER2-positive participants accrued over 5 years and followed for 3 years would result in 162 disease-free survival events and provide 90% statistical power to detect this difference with a 2-sided α of 0.05 and 2 interim analyses. See Limitations and Caveats section.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.85
- param Type
- Hazard Ratio (HR)
- param Value
- 0.97
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.5
- upper Limit
- 26.2
- value
- 19.6
- group Id
- OG001
- lower Limit
- 10.5
- upper Limit
- 23.0
- value
- 14.2
- denoms
- counts
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 96
- units
- Participants
- description
- A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
- id
- OG000
- title
- Chemoradiation and Trastuzumab (Arm 1)
- description
- Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
- id
- OG001
- title
- Chemoradiation (Arm 2)
- param Type
- MEDIAN
- population Description
- Eligible randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.
- title
- Disease-free Survival (DFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice