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NCT00667342 · OUTCOME

Histologic Response by Stratum

A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma · Source last updated 2023-08-07

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
After 6 cycles of chemotherapy, up to 1 year after the start of therapy

What was measured

The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133. Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor). The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done.

Analysis population: All Stratum A participants were evaluated. The tumor sample for analysis was not obtained for one of the 12 Stratum C participants.

Groups in this outcome

A: Localized Resectable Disease

Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.

C: Metastatic Tumors

Stratum C participants had metastatic tumors.

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

Analysis denominator · Participants

GroupSource count
A: Localized Resectable Disease31
C: Metastatic Tumors11

Reported measurements

Grade I
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: Localized Resectable Disease1Not reportedNot reportedNot reportedNot reported
C: Metastatic Tumors0Not reportedNot reportedNot reportedNot reported
Grade IIA
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: Localized Resectable Disease5Not reportedNot reportedNot reportedNot reported
C: Metastatic Tumors1Not reportedNot reportedNot reportedNot reported
Grade IIB
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: Localized Resectable Disease17Not reportedNot reportedNot reportedNot reported
C: Metastatic Tumors7Not reportedNot reportedNot reportedNot reported
Grade III
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: Localized Resectable Disease8Not reportedNot reportedNot reportedNot reported
C: Metastatic Tumors3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Grade I
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        1
    title
    Grade IIA
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        7
    title
    Grade IIB
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        3
    title
    Grade III
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      11
    units
    Participants
description
The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133. Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor). The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done.
groups
  1. description
    Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
    id
    OG000
    title
    A: Localized Resectable Disease
  2. description
    Stratum C participants had metastatic tumors.
    id
    OG001
    title
    C: Metastatic Tumors
param Type
NUMBER
population Description
All Stratum A participants were evaluated. The tumor sample for analysis was not obtained for one of the 12 Stratum C participants.
reporting Status
POSTED
time Frame
After 6 cycles of chemotherapy, up to 1 year after the start of therapy
title
Histologic Response by Stratum
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice