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NCT01418001 · OUTCOME

Overall Objective Response

Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS) · Source last updated 2018-01-11

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
Every 6 weeks up to 2 years

What was measured

Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Groups in this outcome

Level 1: Pazopanib 400 mg QD

Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with 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
Level 1: Pazopanib 400 mg QD5

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Level 1: Pazopanib 400 mg QD3Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Level 1: Pazopanib 400 mg QD2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Stable Disease (SD)
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
groups
  1. description
    Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
    id
    OG000
    title
    Level 1: Pazopanib 400 mg QD
param Type
NUMBER
reporting Status
POSTED
time Frame
Every 6 weeks up to 2 years
title
Overall Objective Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice