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NCT02180867 · OUTCOME

Feasible Dose: Pediatric

Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery · Source last updated 2026-06-17

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

Measure
NUMBER
Unit
milligram per square meter
Interval / dispersion
Not reported
Time frame
After the first 6 weeks of Induction

What was measured

The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.

Analysis population: Pediatric patients, excluding 1 ineligible patient in Dose-Finding CR group and 1 ineligible patient in Dose-Finding RT group

Groups in this outcome

All Pediatric Dose Finding CR Cohorts

Dose-Finding CR: Chemoradiation plus pazopanib

All Pediatric Dose Finding RT Cohorts

Dose-Finding RT: Radiation therapy plus pazopanib

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

Analysis denominator · Participants

GroupSource count
All Pediatric Dose Finding CR Cohorts5
All Pediatric Dose Finding RT Cohorts6

Reported measurements

Source class 1
Values in milligram per square meter · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Pediatric Dose Finding CR Cohorts350Not reportedNot reportedNot reportedNot reported
All Pediatric Dose Finding RT Cohorts450Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        350
      2. group Id
        OG001
        value
        450
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      6
    units
    Participants
description
The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
groups
  1. description
    Dose-Finding CR: Chemoradiation plus pazopanib
    id
    OG000
    title
    All Pediatric Dose Finding CR Cohorts
  2. description
    Dose-Finding RT: Radiation therapy plus pazopanib
    id
    OG001
    title
    All Pediatric Dose Finding RT Cohorts
param Type
NUMBER
population Description
Pediatric patients, excluding 1 ineligible patient in Dose-Finding CR group and 1 ineligible patient in Dose-Finding RT group
reporting Status
POSTED
time Frame
After the first 6 weeks of Induction
title
Feasible Dose: Pediatric
type
PRIMARY
unit Of Measure
milligram per square meter

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

Preserved source evidence · Not medical advice