NCT01196390 · OUTCOME
Disease-free Survival (DFS) by Race
Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer · Source last updated 2026-06-02
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 race.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Chemoradiation and Trastuzumab (Arm 1) | 98 |
|---|
| Chemoradiation (Arm 2) | 96 |
|---|
Reported measurements
American Indian or Alaska Native
Analysis denominator · Participants
| Group | Source count |
|---|
| Chemoradiation and Trastuzumab (Arm 1) | 0 |
|---|
| Chemoradiation (Arm 2) | 2 |
|---|
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation (Arm 2) | NA | Not reported | 9.0 | NA | The was not reached and therefore the upper confidence bound could not be estimated. |
|---|
Black or African American
Analysis denominator · Participants
| Group | Source count |
|---|
| Chemoradiation and Trastuzumab (Arm 1) | 1 |
|---|
| Chemoradiation (Arm 2) | 0 |
|---|
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab (Arm 1) | 19.6 | Not reported | NA | NA | Confidence interval cannot be calculated when there is only one subject. |
|---|
White
Analysis denominator · Participants
| Group | Source count |
|---|
| Chemoradiation and Trastuzumab (Arm 1) | 94 |
|---|
| Chemoradiation (Arm 2) | 92 |
|---|
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab (Arm 1) | 18.0 | Not reported | 12.0 | 24.6 | Not reported |
|---|
| Chemoradiation (Arm 2) | 15.1 | Not reported | 10.6 | 24.1 | Not reported |
|---|
Unknown or Not Reported
Analysis denominator · Participants
| Group | Source count |
|---|
| Chemoradiation and Trastuzumab (Arm 1) | 0 |
|---|
| Chemoradiation (Arm 2) | 2 |
|---|
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation (Arm 2) | 11.5 | Not reported | 9.9 | 13.2 | Not reported |
|---|
Asian
Analysis denominator · Participants
| Group | Source count |
|---|
| Chemoradiation and Trastuzumab (Arm 1) | 3 |
|---|
| Chemoradiation (Arm 2) | 0 |
|---|
Values in months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemoradiation and Trastuzumab (Arm 1) | NA | Not reported | 49.4 | NA | The median was not reached and therefore the upper confidence bound could not be estimated. |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- The was not reached and therefore the upper confidence bound could not be estimated.
- group Id
- OG001
- lower Limit
- 9.0
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- American Indian or Alaska Native
- categories
- measurements
- comment
- Confidence interval cannot be calculated when there is only one subject.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 19.6
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Black or African American
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.0
- upper Limit
- 24.6
- value
- 18.0
- group Id
- OG001
- lower Limit
- 10.6
- upper Limit
- 24.1
- value
- 15.1
- denoms
- counts
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 92
- units
- Participants
- title
- White
- categories
- measurements
- group Id
- OG001
- lower Limit
- 9.9
- upper Limit
- 13.2
- value
- 11.5
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Unknown or Not Reported
- categories
- measurements
- comment
- The median was not reached and therefore the upper confidence bound could not be estimated.
- group Id
- OG000
- lower Limit
- 49.4
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Asian
- 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 race.
- 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 Race
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- months
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Preserved source evidence · Not medical advice
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