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NCT00509665 · OUTCOME

Response Rate

Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer · Source last updated 2018-07-12

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 6 weeks from the time of initial treatment for up to 8 months

What was measured

Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above.

Analysis population: patients who were on study at the time of response assessment

Groups in this outcome

Gemcitabine+Doxorubicin

doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle

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+Doxorubicin17

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine+Doxorubicin4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above.
groups
  1. description
    doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
    id
    OG000
    title
    Gemcitabine+Doxorubicin
param Type
NUMBER
population Description
patients who were on study at the time of response assessment
reporting Status
POSTED
time Frame
Every 6 weeks from the time of initial treatment for up to 8 months
title
Response Rate
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice