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NCT00356031 · OUTCOME

Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
3 years

What was measured

The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.

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: Surgery 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

80-89% necrosis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab, Radiation, and Surgery2Not reportedNot reportedNot reportedNot reported
90-99% necrosis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab, Radiation, and Surgery4Not reportedNot reportedNot reportedNot reported
100% necrosis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab, Radiation, and Surgery3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    80-89% necrosis
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    90-99% necrosis
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    100% necrosis
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.
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: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.
    id
    OG000
    title
    Bevacizumab, Radiation, and Surgery
param Type
NUMBER
reporting Status
POSTED
time Frame
3 years
title
Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice