TriangleNCT01196390 · OUTCOME
Disease-free Survival (DFS) by Ethnicity
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
NIH-required analysis. 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. Data were stratified by ethnicity.
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
Hispanic or Latino
| Group | Source count |
|---|---|
| Chemoradiation and Trastuzumab (Arm 1) | 1 |
| Chemoradiation (Arm 2) | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemoradiation and Trastuzumab (Arm 1) | 6.7 | Not reported | NA | NA | Confidence interval cannot be calculated when there is only one subject. |
| Chemoradiation (Arm 2) | 24.1 | Not reported | 2.7 | NA | The upper confidence bound could not be estimated because there were insufficient events beyond the median survival time. |
Not Hispanic or Latino
| Group | Source count |
|---|---|
| Chemoradiation and Trastuzumab (Arm 1) | 96 |
| Chemoradiation (Arm 2) | 89 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemoradiation and Trastuzumab (Arm 1) | 19.6 | Not reported | 13.9 | 27.5 | Not reported |
| Chemoradiation (Arm 2) | 14.2 | Not reported | 10.5 | 23.0 | Not reported |
Unknown or Not Reported
| Group | Source count |
|---|---|
| Chemoradiation and Trastuzumab (Arm 1) | 1 |
| Chemoradiation (Arm 2) | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemoradiation and Trastuzumab (Arm 1) | 6.0 | Not reported | NA | NA | Confidence interval cannot be calculated when there is only one subject. |
| Chemoradiation (Arm 2) | 14.0 | Not reported | 9.9 | 18.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Confidence interval cannot be calculated when there is only one subject.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.7
- comment
- The upper confidence bound could not be estimated because there were insufficient events beyond the median survival time.
- group Id
- OG001
- lower Limit
- 2.7
- upper Limit
- NA
- value
- 24.1
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Hispanic or Latino
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.9
- upper Limit
- 27.5
- value
- 19.6
- group Id
- OG001
- lower Limit
- 10.5
- upper Limit
- 23.0
- value
- 14.2
- denoms
- counts
- group Id
- OG000
- value
- 96
- group Id
- OG001
- value
- 89
- units
- Participants
- title
- Not Hispanic or Latino
- categories
- measurements
- comment
- Confidence interval cannot be calculated when there is only one subject.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.0
- group Id
- OG001
- lower Limit
- 9.9
- upper Limit
- 18.2
- value
- 14.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 96
- units
- Participants
- description
- NIH-required analysis. 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. Data were stratified by ethnicity.
- 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) by Ethnicity
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice