Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02162732 · OUTCOME

Overall Response Rate (ORR) of Participants by the Presence of Radiologically Assessable Disease by Cross-sectional CT or MRI Imaging and/or by MIBG or PET Scans.

Molecular-Guided Therapy for Childhood Cancer · Source last updated 2025-11-03

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Followed until off therapy, generally 4 years

What was measured

To determine the activity of treatments chosen based on Overall response rate (ORR) using RESIST criteria. The assessment of response will include the initial measurable targets and will be performed after cycle 2, then after every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI imaging and/or by MIBG or PET scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, At least a 20% increase in the sum of the disease measurements for measurable lesions, Stable Disease, Neither sufficient decrease to qualify for PR or sufficient increase to qualify for PD from study entry. Overall Response (OR) = CR + PR.

Analysis population: Having at least one disease evaluation following completion of at least one cycle of molecular-guided therapy

Groups in this outcome

Neuroblastoma

Subjects on study with a diagnosis of Neuroblastoma

CNS Tumors

Subjects on study with a diagnosis of a CNS Tumor which included, but was not limited to, Ependymoma, Glioblastoma, Diffuse Midline Glioma, and Other CNS Tumors.

Rare Tumors

Subjects on study with a diagnosis of a rare solid tumor which included, but was not limited to, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma, and Other Rare Tumors.

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

Analysis denominator · Participants

GroupSource count
Neuroblastoma27
CNS Tumors37
Rare Tumors60

Reported measurements

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Neuroblastoma4Not reportedNot reportedNot reportedNot reported
CNS Tumors2Not reportedNot reportedNot reportedNot reported
Rare Tumors5Not reportedNot reportedNot reportedNot reported
No Evidence of Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Neuroblastoma1Not reportedNot reportedNot reportedNot reported
CNS Tumors11Not reportedNot reportedNot reportedNot reported
Rare Tumors6Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Neuroblastoma0Not reportedNot reportedNot reportedNot reported
CNS Tumors4Not reportedNot reportedNot reportedNot reported
Rare Tumors7Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Neuroblastoma13Not reportedNot reportedNot reportedNot reported
CNS Tumors10Not reportedNot reportedNot reportedNot reported
Rare Tumors18Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Neuroblastoma9Not reportedNot reportedNot reportedNot reported
CNS Tumors10Not reportedNot reportedNot reportedNot reported
Rare Tumors24Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        5
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        6
    title
    No Evidence of Disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        7
    title
    Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        18
    title
    Stable Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        24
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      37
    3. group Id
      OG002
      value
      60
    units
    Participants
description
To determine the activity of treatments chosen based on Overall response rate (ORR) using RESIST criteria. The assessment of response will include the initial measurable targets and will be performed after cycle 2, then after every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI imaging and/or by MIBG or PET scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, At least a 20% increase in the sum of the disease measurements for measurable lesions, Stable Disease, Neither sufficient decrease to qualify for PR or sufficient increase to qualify for PD from study entry. Overall Response (OR) = CR + PR.
groups
  1. description
    Subjects on study with a diagnosis of Neuroblastoma
    id
    OG000
    title
    Neuroblastoma
  2. description
    Subjects on study with a diagnosis of a CNS Tumor which included, but was not limited to, Ependymoma, Glioblastoma, Diffuse Midline Glioma, and Other CNS Tumors.
    id
    OG001
    title
    CNS Tumors
  3. description
    Subjects on study with a diagnosis of a rare solid tumor which included, but was not limited to, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma, and Other Rare Tumors.
    id
    OG002
    title
    Rare Tumors
param Type
COUNT_OF_PARTICIPANTS
population Description
Having at least one disease evaluation following completion of at least one cycle of molecular-guided therapy
reporting Status
POSTED
time Frame
Followed until off therapy, generally 4 years
title
Overall Response Rate (ORR) of Participants by the Presence of Radiologically Assessable Disease by Cross-sectional CT or MRI Imaging and/or by MIBG or PET Scans.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice