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NCT01344018 · OUTCOME

Tumor Response to Preoperative Radiotherapy

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
Two weeks after completion of Pre-operative Radiotherapy, before Surgery

What was measured

For patients that received preoperative radiotherapy, the tumor response was assessed using RECIST 1.1. Response criteria were essentially based on a set of measurable lesions identified at baseline as target lesions, and followed at the end of the radiotherapy. Response was not the primary endpoint, so a confirmatory CT-scan was not mandatory.

Analysis population: Tumor response using RECIST 1.1 was only assessed for patients receiving preoperative radiotherapy.

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 Alone0
Preoperative Radiotherapy Followed by En-bloc Surgery133

Reported measurements

Partial response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Preoperative Radiotherapy Followed by En-bloc Surgery4Not reportedNot reportedNot reportedNot reported
Stable disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Preoperative Radiotherapy Followed by En-bloc Surgery99Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Preoperative Radiotherapy Followed by En-bloc Surgery18Not reportedNot reportedNot reportedNot reported
Early death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Preoperative Radiotherapy Followed by En-bloc Surgery1Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Preoperative Radiotherapy Followed by En-bloc Surgery11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        4
    title
    Partial response
  2. categories
    1. measurements
      1. group Id
        OG001
        value
        99
    title
    Stable disease
  3. categories
    1. measurements
      1. group Id
        OG001
        value
        18
    title
    Progressive disease
  4. categories
    1. measurements
      1. group Id
        OG001
        value
        1
    title
    Early death
  5. categories
    1. measurements
      1. group Id
        OG001
        value
        11
    title
    Not evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      133
    units
    Participants
description
For patients that received preoperative radiotherapy, the tumor response was assessed using RECIST 1.1. Response criteria were essentially based on a set of measurable lesions identified at baseline as target lesions, and followed at the end of the radiotherapy. Response was not the primary endpoint, so a confirmatory CT-scan was not mandatory.
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
population Description
Tumor response using RECIST 1.1 was only assessed for patients receiving preoperative radiotherapy.
reporting Status
POSTED
time Frame
Two weeks after completion of Pre-operative Radiotherapy, before Surgery
title
Tumor Response to Preoperative Radiotherapy
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice