TriangleNCT01013649 · OUTCOME
Overall Survival (Percentage of Participants Alive) [Phase III] by Sex
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 sex.
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 | Source count |
|---|---|
| Arm III (Chemotherapy) | 174 |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 180 |
Reported measurements
Female
| Group | Source count |
|---|---|
| Arm III (Chemotherapy) | 74 |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 85 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm III (Chemotherapy) | 26.4 | Not reported | 19.6 | 36.3 | Not reported |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 27.3 | Not reported | 24.9 | 34.6 | Not reported |
Male
| Group | Source count |
|---|---|
| Arm III (Chemotherapy) | 100 |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 95 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm III (Chemotherapy) | 34.1 | Not reported | 26.5 | 41.7 | Not reported |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 28.2 | Not reported | 23.3 | 33.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.6
- upper Limit
- 36.3
- value
- 26.4
- group Id
- OG001
- lower Limit
- 24.9
- upper Limit
- 34.6
- value
- 27.3
- denoms
- counts
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 85
- units
- Participants
- title
- Female
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.5
- upper Limit
- 41.7
- value
- 34.1
- group Id
- OG001
- lower Limit
- 23.3
- upper Limit
- 33.8
- value
- 28.2
- denoms
- counts
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 95
- units
- Participants
- title
- Male
- 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 sex.
- 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 Sex
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- months
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Preserved source evidence · Not medical advice