TriangleNCT01013649 · OUTCOME
Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III]
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 disease event, 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
Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 2 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all participants have five years potential follow-up from second step randomization.
Analysis population: Participants randomized at step 2.
Groups in this outcome
Arm III (Chemotherapy)
Patients receive the same treatment as in arm I for 1 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 for 1 month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm III (Chemotherapy) | 12.4 | Not reported | 9.6 | 15.2 | Not reported |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 15.6 | Not reported | 13.2 | 18.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.99
- estimate Comment
- Reference level = Arm III
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.82
Complete source fields
- analyses
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.99
- estimate Comment
- Reference level = Arm III
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.82
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.6
- upper Limit
- 15.2
- value
- 12.4
- group Id
- OG001
- lower Limit
- 13.2
- upper Limit
- 18.8
- value
- 15.6
- denoms
- counts
- group Id
- OG000
- value
- 174
- group Id
- OG001
- value
- 180
- units
- Participants
- description
- Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 2 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all participants have five years potential follow-up from second step randomization.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients receive the same treatment as in arm I for 1 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 for 1 month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (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.
- reporting Status
- POSTED
- time Frame
- From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to disease event, 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
- Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III]
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice