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NCT01958580 · OUTCOME

Recurrence-free Survival

Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery · Source last updated 2023-08-16

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Date of entry to date of reappearance of disease, assessed at 2 years. The study was terminated prior to analyses

What was measured

Two-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. In the event of censoring before two years, a Kaplan-Meier estimate of the survival probability will be used and a Kaplan-Meier survival curve will be estimated and presented as well. The study was terminated prior to analyses

Analysis population: Data pertaining to Recurrence-free Survival was not collected/aggregated and therefore not analyzed.

Groups in this outcome

Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT)

CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks. Gemcitabine Hydrochloride: Given IV Docetaxel: Given IV Internal Radiation Therapy: Undergo brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
Two-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. In the event of censoring before two years, a Kaplan-Meier estimate of the survival probability will be used and a Kaplan-Meier survival curve will be estimated and presented as well. The study was terminated prior to analyses
groups
  1. description
    CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks. Gemcitabine Hydrochloride: Given IV Docetaxel: Given IV Internal Radiation Therapy: Undergo brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies
    id
    OG000
    title
    Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT)
population Description
Data pertaining to Recurrence-free Survival was not collected/aggregated and therefore not analyzed.
reporting Status
POSTED
time Frame
Date of entry to date of reappearance of disease, assessed at 2 years. The study was terminated prior to analyses
title
Recurrence-free Survival
type
PRIMARY

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Preserved source evidence · Not medical advice