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NCT00281840 · OUTCOME

Response Rate

Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2015-06-09

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
5 years

What was measured

The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). A response will be determined by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD

Analysis population: Patients with evaluable tumors at the end of the study

Groups in this outcome

Bevacizumab With Docetaxel and Radiation Therapy

bevacizumab: Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity. docetaxel: docetaxel IV over 1 hour once a week for 8 weeks conventional surgery: 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection radiation therapy: radiotherapy once daily, 5 days a week, for 8 weeks

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 With Docetaxel and Radiation Therapy26

Reported measurements

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab With Docetaxel and Radiation Therapy16Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab With Docetaxel and Radiation Therapy6Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab With Docetaxel and Radiation Therapy1Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bevacizumab With Docetaxel and Radiation Therapy3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Progressive Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Stable Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). A response will be determined by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
groups
  1. description
    bevacizumab: Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity. docetaxel: docetaxel IV over 1 hour once a week for 8 weeks conventional surgery: 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection radiation therapy: radiotherapy once daily, 5 days a week, for 8 weeks
    id
    OG000
    title
    Bevacizumab With Docetaxel and Radiation Therapy
param Type
NUMBER
population Description
Patients with evaluable tumors at the end of the study
reporting Status
POSTED
time Frame
5 years
title
Response Rate
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice