TriangleNCT01344018 · OUTCOME
Acute Toxicity Profile of Preoperative Radiotherapy.
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 date of randomization to the date of surgical procedure, prior to surgery
What was measured
The acute toxicity was assessed in randomized patients who received at least one dose of preoperative radiotherapy (RT). It follows Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in the RT safety population, assuming the following classification: * Grade 0 No event reported * 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. For each item of the CTCAE, the worst grade of acute toxicity from the data of randomization prior to surgery was taken
Analysis population: Only patients in the "Preoperative radiotherapy followed by en-bloc surgery" that received at least one dose of radiotherapy were considered for this secondary 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 | 0 |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 127 |
Reported measurements
Source class 1
CTCAE Grade 0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Preoperative Radiotherapy Followed by En-bloc Surgery | 4 | Not reported | Not reported | Not reported | Not reported |
CTCAE Grade 1-2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Preoperative Radiotherapy Followed by En-bloc Surgery | 106 | Not reported | Not reported | Not reported | Not reported |
CTCAE Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Preoperative Radiotherapy Followed by En-bloc Surgery | 15 | Not reported | Not reported | Not reported | Not reported |
CTCAE Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Preoperative Radiotherapy Followed by En-bloc Surgery | 1 | Not reported | Not reported | Not reported | Not reported |
CTCAE Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Preoperative Radiotherapy Followed by En-bloc Surgery | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- value
- 4
- title
- CTCAE Grade 0
- measurements
- group Id
- OG001
- value
- 106
- title
- CTCAE Grade 1-2
- measurements
- group Id
- OG001
- value
- 15
- title
- CTCAE Grade 3
- measurements
- group Id
- OG001
- value
- 1
- title
- CTCAE Grade 4
- measurements
- group Id
- OG001
- value
- 1
- title
- CTCAE Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 127
- units
- Participants
- description
- The acute toxicity was assessed in randomized patients who received at least one dose of preoperative radiotherapy (RT). It follows Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in the RT safety population, assuming the following classification: * Grade 0 No event reported * 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. For each item of the CTCAE, the worst grade of acute toxicity from the data of randomization prior to surgery was taken
- 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
- Only patients in the "Preoperative radiotherapy followed by en-bloc surgery" that received at least one dose of radiotherapy were considered for this secondary endpoint.
- reporting Status
- POSTED
- time Frame
- From date of randomization to the date of surgical procedure, prior to surgery
- title
- Acute Toxicity Profile of Preoperative Radiotherapy.
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice