NCT01344018 · OUTCOME

Number of Patients Alive

Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma · Source last updated 2023-04-24

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: Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 7 years

What was measured

Alive patients were censored at the date of last follow-up. Causes of death were recorded and reported as a table.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Surgery Alone	133
Preoperative Radiotherapy Followed by En-bloc Surgery	133

Reported measurements

Alive (censored)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Surgery Alone	111	Not reported	Not reported	Not reported	Not reported
Preoperative Radiotherapy Followed by En-bloc Surgery	108	Not reported	Not reported	Not reported	Not reported

Death (event)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Surgery Alone	22	Not reported	Not reported	Not reported	Not reported
Preoperative Radiotherapy Followed by En-bloc Surgery	25	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.65
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.05
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.615
param Type
Hazard Ratio (HR)
param Value
1.16
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.65
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.05
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.615
param Type
Hazard Ratio (HR)
param Value
1.16
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
value
111
group Id
OG001
value
108
title
Alive (censored)
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
25
title
Death (event)

denoms

counts
group Id
OG000
value
133
group Id
OG001
value
133
units
Participants

description

Alive patients were censored at the date of last follow-up. Causes of death were recorded and reported as a table.

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

Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 7 years

title

Number of Patients Alive

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice