TriangleNCT01344018 · OUTCOME
Late Complications
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
- From day 60 after surgery till end of follow-up, up to 7 years
What was measured
The late toxicities occurring more than 60 days after surgery. These were reported using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. This scales the observed toxicity from Grade 1 to 5, assuming the following classification: * Grade 0 no event * Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. * Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. * Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. * Grade 4 Life-threatening consequences; urgent intervention indicated. * Grade 5 Death related to AE. Full AE reporting can be found in the Adverse Event Section.
Analysis population: all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
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 | 128 |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 127 |
Reported measurements
Source class 1
CTCAE Grade 0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 58 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 53 | Not reported | Not reported | Not reported | Not reported |
CTCAE Grade 1-2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 51 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 50 | Not reported | Not reported | Not reported | Not reported |
CTCAE Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 17 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 20 | Not reported | Not reported | Not reported | Not reported |
CTCAE Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 2 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 4 | Not reported | Not reported | Not reported | Not reported |
CTCAE Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 0 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 53
- title
- CTCAE Grade 0
- measurements
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 50
- title
- CTCAE Grade 1-2
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 20
- title
- CTCAE Grade 3
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- title
- CTCAE Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- CTCAE Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 128
- group Id
- OG001
- value
- 127
- units
- Participants
- description
- The late toxicities occurring more than 60 days after surgery. These were reported using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. This scales the observed toxicity from Grade 1 to 5, assuming the following classification: * Grade 0 no event * Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. * Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. * Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. * Grade 4 Life-threatening consequences; urgent intervention indicated. * Grade 5 Death related to AE. Full AE reporting can be found in the Adverse Event Section.
- 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
- all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
- reporting Status
- POSTED
- time Frame
- From day 60 after surgery till end of follow-up, up to 7 years
- title
- Late Complications
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice