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NCT00520936 · OUTCOME

Percentage of Participants With Overall Tumor Response (Response Rate)

A Study of Pemetrexed in Children With Recurrent Cancer · Source last updated 2011-02-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
baseline to measured progressive disease (up to 1 year)

What was measured

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent \[%\])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)\*100.

Analysis population: All treated participants.

Groups in this outcome

Osteosarcoma

Pemetrexed 1910 milligrams per meters squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old)

Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors

Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)

Rhabdomyosarcoma

Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)

Neuroblastoma (Measureable Disease)

Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)

Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)

Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)

Ependymoma

Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)

Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor

Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)

Non-Brainstem High-Grade Glioma

Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)

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

Analysis denominator · Participants

GroupSource count
Osteosarcoma10
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors11
Rhabdomyosarcoma9
Neuroblastoma (Measureable Disease)5
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)6
Ependymoma10
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor11
Non-Brainstem High-Grade Glioma10

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Osteosarcoma0Not reportedNot reportedNot reportedNot reported
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors0Not reportedNot reportedNot reportedNot reported
Rhabdomyosarcoma0Not reportedNot reportedNot reportedNot reported
Neuroblastoma (Measureable Disease)0Not reportedNot reportedNot reportedNot reported
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)0Not reportedNot reportedNot reportedNot reported
Ependymoma0Not reportedNot reportedNot reportedNot reported
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor0Not reportedNot reportedNot reportedNot reported
Non-Brainstem High-Grade Glioma0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      10
    7. group Id
      OG006
      value
      11
    8. group Id
      OG007
      value
      10
    units
    Participants
description
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent \[%\])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)\*100.
groups
  1. description
    Pemetrexed 1910 milligrams per meters squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old)
    id
    OG000
    title
    Osteosarcoma
  2. description
    Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
    id
    OG001
    title
    Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
  3. description
    Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
    id
    OG002
    title
    Rhabdomyosarcoma
  4. description
    Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
    id
    OG003
    title
    Neuroblastoma (Measureable Disease)
  5. description
    Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
    id
    OG004
    title
    Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)
  6. description
    Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
    id
    OG005
    title
    Ependymoma
  7. description
    Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
    id
    OG006
    title
    Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor
  8. description
    Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
    id
    OG007
    title
    Non-Brainstem High-Grade Glioma
param Type
NUMBER
population Description
All treated participants.
reporting Status
POSTED
time Frame
baseline to measured progressive disease (up to 1 year)
title
Percentage of Participants With Overall Tumor Response (Response Rate)
type
PRIMARY
unit Of Measure
Percentage of Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice