TriangleNCT01344018 · OUTCOME
Number of Patients With an Abdominal Recurrence
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- ARFI was measured from the date of randomization to the date of abdominal relapse, up to a maximum of 7 years
What was measured
Abdominal recurrence was defined in the ARFS section. The following are considered competing events: * death in the absence of abdominal failure * distant metastases diagnosed before abdominal failure Patients without one of these events were censored at the date of last follow-up.
Analysis population: Note that distant metastasis before or in the absence of abdominal recurrence was counted as a competing risk for this endpoint - whereas distant metastasis in the absence of abdominal recurrence was considered a non-event for the primary endpoint (ARFS). This explains the difference in non-events between the survival and interval endpoint.
Groups in this outcome
Surgery Alone
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery
Preoperative Radiotherapy Followed by En-bloc Surgery
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
| Group | Source count |
|---|---|
| Surgery Alone | 133 |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 133 |
Reported measurements
Source class 1
No event (censored)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 61 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 65 | Not reported | Not reported | Not reported | Not reported |
Abdominal recurrence
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 46 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 48 | Not reported | Not reported | Not reported | Not reported |
Competing event (see outcome measure description)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 26 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 20 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.74
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.60
- group Ids
- OG000
- OG001
- non Inferiority Comment
- ARFI was described using cumulative incidence curves. ARFI was compared between the two treatment arms using a Fine and Gray model.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.658
- p Value Comment
- A 5% significance level was considered as a threshold for statistical significance.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.09
- statistical Method
- Fine and Gray model
Complete source fields
- analyses
- ci Lower Limit
- 0.74
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.60
- group Ids
- OG000
- OG001
- non Inferiority Comment
- ARFI was described using cumulative incidence curves. ARFI was compared between the two treatment arms using a Fine and Gray model.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.658
- p Value Comment
- A 5% significance level was considered as a threshold for statistical significance.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.09
- statistical Method
- Fine and Gray model
- classes
- categories
- measurements
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 65
- title
- No event (censored)
- measurements
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 48
- title
- Abdominal recurrence
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 20
- title
- Competing event (see outcome measure description)
- denoms
- counts
- group Id
- OG000
- value
- 133
- group Id
- OG001
- value
- 133
- units
- Participants
- description
- Abdominal recurrence was defined in the ARFS section. The following are considered competing events: * death in the absence of abdominal failure * distant metastases diagnosed before abdominal failure Patients without one of these events were censored at the date of last follow-up.
- groups
- description
- En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery
- id
- OG000
- title
- Surgery Alone
- description
- 3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
- id
- OG001
- title
- Preoperative Radiotherapy Followed by En-bloc Surgery
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Note that distant metastasis before or in the absence of abdominal recurrence was counted as a competing risk for this endpoint - whereas distant metastasis in the absence of abdominal recurrence was considered a non-event for the primary endpoint (ARFS). This explains the difference in non-events between the survival and interval endpoint.
- reporting Status
- POSTED
- time Frame
- ARFI was measured from the date of randomization to the date of abdominal relapse, up to a maximum of 7 years
- title
- Number of Patients With an Abdominal Recurrence
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice