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NCT00356031 · OUTCOME

Average Change in Blood Flow, Blood Volume,and Permeability Surface Area

Bevacizumab and Radiation Therapy for Sarcomas · Source last updated 2017-05-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Percent Reduction
Interval / dispersion
Full Range
Time frame
3 years

What was measured

The percentage reduction in blood flow, blood volume,and permeability surface area of the tumor following combination therapy as determined by perfusion CT (computerized tomography) scan. The percent change represents the combined average percent change for flow, volume, and permeability together.

Groups in this outcome

Bevacizumab, Radiation, and Surgery

Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT) Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good. Surgery: Surgical resection is performed 6-7 weeks after completion of neoadjuvant 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
Bevacizumab, Radiation, and Surgery20

Reported measurements

Source class 1
Values in Percent Reduction · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bevacizumab, Radiation, and Surgery67Not reported6272Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    <.05
    statistical Method
    t-test, 1 sided
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    <.05
    statistical Method
    t-test, 1 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        62
        upper Limit
        72
        value
        67
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
The percentage reduction in blood flow, blood volume,and permeability surface area of the tumor following combination therapy as determined by perfusion CT (computerized tomography) scan. The percent change represents the combined average percent change for flow, volume, and permeability together.
dispersion Type
Full Range
groups
  1. description
    Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT) Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good. Surgery: Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy.
    id
    OG000
    title
    Bevacizumab, Radiation, and Surgery
param Type
MEAN
reporting Status
POSTED
time Frame
3 years
title
Average Change in Blood Flow, Blood Volume,and Permeability Surface Area
type
SECONDARY
unit Of Measure
Percent Reduction

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

Preserved source evidence · Not medical advice