NCT01013649 · OUTCOME
Overall Survival (Percentage of Participants Alive) [Phase III] by Race
Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery · Source last updated 2026-02-23
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to the date of death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
What was measured
NIH-required analysis. Overall survival (OS) is estimated by the Kaplan-Meier method. Survival time is measured from step 2 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all patients have five years potential follow-up from step 2 randomization.
Analysis population: Participants randomized at step 2. Data were stratified by race.
Groups in this outcome
Arm III (Chemotherapy)
Patients receive the same treatment as in arm I or arm II for one month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
Arm IV (Chemotherapy, Chemoradiotherapy)
Patients receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (RT) (3-dimensional conformal radiotherapy or intensity modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
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 |
|---|
| Arm III (Chemotherapy) | 174 |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | 180 |
|---|
Reported measurements
American Indian or Alaska Native
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm III (Chemotherapy) | 1 |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | 1 |
|---|
Values in months · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm III (Chemotherapy) | NA | Not reported | NA | NA | The median survival time was not reached because too few deaths occurred in this subgroup to allow estimation of the median and its associated confidence bounds. |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | NA | Not reported | NA | NA | The median survival time was not reached because too few deaths occurred in this subgroup to allow estimation of the median and its associated confidence bounds. |
|---|
Asian
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm III (Chemotherapy) | 4 |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | 8 |
|---|
Values in months · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm III (Chemotherapy) | 81.8 | Not reported | 4.7 | 115.4 | Not reported |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | 19.6 | Not reported | 11.4 | 44.2 | Not reported |
|---|
Native Hawaiian or Other Pacific Islander
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm III (Chemotherapy) | 0 |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | 2 |
|---|
Values in months · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | NA | Not reported | 37.3 | NA | The median survival time was not reached because too few deaths occurred in this subgroup to allow estimation of the median and its associated upper confidence bound. |
|---|
Black or African American
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm III (Chemotherapy) | 19 |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | 27 |
|---|
Values in months · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm III (Chemotherapy) | 17.5 | Not reported | 8.4 | 27.3 | Not reported |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | 24.5 | Not reported | 17.6 | 29.6 | Not reported |
|---|
White
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm III (Chemotherapy) | 147 |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | 139 |
|---|
Values in months · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm III (Chemotherapy) | 35.2 | Not reported | 26.4 | 41.5 | Not reported |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | 28.2 | Not reported | 24.3 | 35.8 | Not reported |
|---|
Unknown or not reported
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm III (Chemotherapy) | 3 |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | 3 |
|---|
Values in months · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm III (Chemotherapy) | 32.0 | Not reported | 20.1 | 44.0 | Not reported |
|---|
| Arm IV (Chemotherapy, Chemoradiotherapy) | 42.5 | Not reported | 9.1 | NA | The median survival time was not reached because too few deaths occurred in this subgroup to allow estimation of the upper confidence bound. |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- The median survival time was not reached because too few deaths occurred in this subgroup to allow estimation of the median and its associated confidence bounds.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median survival time was not reached because too few deaths occurred in this subgroup to allow estimation of the median and its associated confidence bounds.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- American Indian or Alaska Native
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.7
- upper Limit
- 115.4
- value
- 81.8
- group Id
- OG001
- lower Limit
- 11.4
- upper Limit
- 44.2
- value
- 19.6
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Asian
- categories
- measurements
- comment
- The median survival time was not reached because too few deaths occurred in this subgroup to allow estimation of the median and its associated upper confidence bound.
- group Id
- OG001
- lower Limit
- 37.3
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Native Hawaiian or Other Pacific Islander
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.4
- upper Limit
- 27.3
- value
- 17.5
- group Id
- OG001
- lower Limit
- 17.6
- upper Limit
- 29.6
- value
- 24.5
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Black or African American
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.4
- upper Limit
- 41.5
- value
- 35.2
- group Id
- OG001
- lower Limit
- 24.3
- upper Limit
- 35.8
- value
- 28.2
- denoms
- counts
- group Id
- OG000
- value
- 147
- group Id
- OG001
- value
- 139
- units
- Participants
- title
- White
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.1
- upper Limit
- 44.0
- value
- 32.0
- comment
- The median survival time was not reached because too few deaths occurred in this subgroup to allow estimation of the upper confidence bound.
- group Id
- OG001
- lower Limit
- 9.1
- upper Limit
- NA
- value
- 42.5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Unknown or not reported
- denoms
- counts
- group Id
- OG000
- value
- 174
- group Id
- OG001
- value
- 180
- units
- Participants
- description
- NIH-required analysis. Overall survival (OS) is estimated by the Kaplan-Meier method. Survival time is measured from step 2 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all patients have five years potential follow-up from step 2 randomization.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients receive the same treatment as in arm I or arm II for one month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
- id
- OG000
- title
- Arm III (Chemotherapy)
- description
- Patients receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (RT) (3-dimensional conformal radiotherapy or intensity modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
- id
- OG001
- title
- Arm IV (Chemotherapy, Chemoradiotherapy)
- param Type
- MEDIAN
- population Description
- Participants randomized at step 2. Data were stratified by race.
- reporting Status
- POSTED
- time Frame
- From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to the date of death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
- title
- Overall Survival (Percentage of Participants Alive) [Phase III] by Race
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- months
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