TriangleNCT01344018 · OUTCOME
Number of Patients With Abdominal Recurrence or Death
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
- ARFS was measured from date of randomization to date of abdominal relapse or death, whichever occurred first, up to a maximum of 7 years.
What was measured
Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic events. Patients with distant metastases were followed until local failure was detected. Patients without one of these events were censored at the date of last follow-up.
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
No event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 72 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 73 | Not reported | Not reported | Not reported | Not reported |
Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 61 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 60 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.44
- estimate Comment
- The arm having surgery alone was the reference arm.
- group Description
- Sample size was determined to provide 90% power for detecting a Hazard Ratio (HR)=0.52 (which corresponds to a 20% difference in ARFS rate at 5 years, from 50% in the surgery arm to 70% in the experimental arm) at a global 2-sided 5% significance level assuming ARFS followed an exponential distribution in both arms. This test required 102 events at the time of the statistical analysis.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Time assessment biases were taken into account for the primary endpoint: * Surgery alone arm: abdominal recurrence occurring prior to week 14 assessment was counted as occurring at week 14; progression occurring after the week 14 was counted as occurring at week 24. * Preoperative RT arm: abdominal recurrence occurring was counted as occurring at week 14; and any abdominal recurrence occurring after and prior to or during the week 24 will be counted as occurring at week 24.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.955
- p Value Comment
- A 5% significance level was considered as a threshold for statistical significance.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.01
- statistical Comment
- The time assessment biases correction described before was not applied to patients for whom death was the first event.
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.44
- estimate Comment
- The arm having surgery alone was the reference arm.
- group Description
- Sample size was determined to provide 90% power for detecting a Hazard Ratio (HR)=0.52 (which corresponds to a 20% difference in ARFS rate at 5 years, from 50% in the surgery arm to 70% in the experimental arm) at a global 2-sided 5% significance level assuming ARFS followed an exponential distribution in both arms. This test required 102 events at the time of the statistical analysis.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Time assessment biases were taken into account for the primary endpoint: * Surgery alone arm: abdominal recurrence occurring prior to week 14 assessment was counted as occurring at week 14; progression occurring after the week 14 was counted as occurring at week 24. * Preoperative RT arm: abdominal recurrence occurring was counted as occurring at week 14; and any abdominal recurrence occurring after and prior to or during the week 24 will be counted as occurring at week 24.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.955
- p Value Comment
- A 5% significance level was considered as a threshold for statistical significance.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.01
- statistical Comment
- The time assessment biases correction described before was not applied to patients for whom death was the first event.
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- value
- 72
- group Id
- OG001
- value
- 73
- title
- No event
- categories
- measurements
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 60
- title
- Event
- denoms
- counts
- group Id
- OG000
- value
- 133
- group Id
- OG001
- value
- 133
- units
- Participants
- description
- Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic events. Patients with distant metastases were followed until local failure was detected. 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
- reporting Status
- POSTED
- time Frame
- ARFS was measured from date of randomization to date of abdominal relapse or death, whichever occurred first, up to a maximum of 7 years.
- title
- Number of Patients With Abdominal Recurrence or Death
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice