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NCT01012297 · OUTCOME

Progression-free Survival

Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma · Source last updated 2026-06-24

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

What was measured

Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.

Analysis population: All randomized

Groups in this outcome

Arm I Gem+Doce+Placebo

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC Placebo: Given IV

Arm II Gem+Doce+Bev

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Bevacizumab: Given IV Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC

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

Analysis denominator · Participants

GroupSource count
Arm I Gem+Doce+Placebo54
Arm II Gem+Doce+Bev53

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I Gem+Doce+Placebo6.2Not reported2.99.9Not reported
Arm II Gem+Doce+Bev4.2Not reported3.18.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.9
        upper Limit
        9.9
        value
        6.2
      2. group Id
        OG001
        lower Limit
        3.1
        upper Limit
        8.4
        value
        4.2
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      53
    units
    Participants
description
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC Placebo: Given IV
    id
    OG000
    title
    Arm I Gem+Doce+Placebo
  2. description
    Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Bevacizumab: Given IV Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC
    id
    OG001
    title
    Arm II Gem+Doce+Bev
param Type
MEDIAN
population Description
All randomized
reporting Status
POSTED
time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
title
Progression-free Survival
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice