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NCT00248560 · OUTCOME

Response (Complete Response [CR] + Partial Response [PR])

Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer · Source last updated 2019-03-05

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
every 8 weeks for approximately 8 - 48 weeks

What was measured

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Groups in this outcome

Gemcitabine, Docetaxel

Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.

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

Analysis denominator · Participants

GroupSource count
Gemcitabine, Docetaxel36

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel6Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.08
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.32
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Response rate
    param Value
    0.17
Complete source fields
analyses
  1. ci Lower Limit
    0.08
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.32
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Response rate
    param Value
    0.17
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    units
    Participants
description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
groups
  1. description
    Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
    id
    OG000
    title
    Gemcitabine, Docetaxel
param Type
NUMBER
reporting Status
POSTED
time Frame
every 8 weeks for approximately 8 - 48 weeks
title
Response (Complete Response [CR] + Partial Response [PR])
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice