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NCT00423150 · OUTCOME

Tumor Responses (Complete and Partial Response)

Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED) · Source last updated 2017-06-08

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
From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first

What was measured

Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): 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: Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Groups in this outcome

Temozolomide

Temozolomide capsules 150 mg/m\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.

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

Analysis denominator · Participants

GroupSource count
Temozolomide82

Reported measurements

Number of participants with Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Temozolomide0Not reportedNot reportedNot reportedNot reported
Number of participants with Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Temozolomide5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Number of participants with Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Number of participants with Partial Response
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    units
    Participants
description
Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): 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
    Temozolomide capsules 150 mg/m\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
    id
    OG000
    title
    Temozolomide
param Type
NUMBER
population Description
Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
reporting Status
POSTED
time Frame
From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first
title
Tumor Responses (Complete and Partial Response)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice