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NCT00503997 · OUTCOME

Patient Response to Treatment Measured by RECIST Criteria

Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer · Source last updated 2012-05-10

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
at 8 weeks

What was measured

RECIST response categories: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.

Groups in this outcome

Pemetrexed/Oxaliplatin

Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.

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

Analysis denominator · Participants

GroupSource count
Pemetrexed/Oxaliplatin42

Reported measurements

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed/Oxaliplatin1Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed/Oxaliplatin18Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed/Oxaliplatin19Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed/Oxaliplatin2Not reportedNot reportedNot reportedNot reported
Not Evaluable
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed/Oxaliplatin2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Progressive Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    units
    Participants
description
RECIST response categories: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
groups
  1. description
    Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
    id
    OG000
    title
    Pemetrexed/Oxaliplatin
param Type
NUMBER
reporting Status
POSTED
time Frame
at 8 weeks
title
Patient Response to Treatment Measured by RECIST Criteria
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice