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NCT01344018 · OUTCOME

Number of Patients With Metastases or Death

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
Metastases free survival was measured from the date of randomization to the date of occurrence of distant metastases or death, whichever occurred first, up to a maximum of 7 years.

What was measured

Alive and metastases free patients will be 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Surgery Alone133
Preoperative Radiotherapy Followed by En-bloc Surgery133

Reported measurements

Source class 1

Alive and metastases free (censored)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Surgery Alone88Not reportedNot reportedNot reportedNot reported
Preoperative Radiotherapy Followed by En-bloc Surgery92Not reportedNot reportedNot reportedNot reported

metastasis and/or death (event)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Surgery Alone45Not reportedNot reportedNot reportedNot reported
Preoperative Radiotherapy Followed by En-bloc Surgery41Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.36
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.595
    p Value Comment
    A 5% significance level was considered as a threshold for statistical significance.
    param Type
    Hazard Ratio (HR)
    param Value
    0.89
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.36
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.595
    p Value Comment
    A 5% significance level was considered as a threshold for statistical significance.
    param Type
    Hazard Ratio (HR)
    param Value
    0.89
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        92
      title
      Alive and metastases free (censored)
    2. measurements
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        41
      title
      metastasis and/or death (event)
denoms
  1. counts
    1. group Id
      OG000
      value
      133
    2. group Id
      OG001
      value
      133
    units
    Participants
description
Alive and metastases free patients will be censored at the date of last follow-up.
groups
  1. 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
  2. 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
Metastases free survival was measured from the date of randomization to the date of occurrence of distant metastases or death, whichever occurred first, up to a maximum of 7 years.
title
Number of Patients With Metastases or Death
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice