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NCT02228681 · OUTCOME

Median Progression-free Survival

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer · Source last updated 2024-09-19

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
Tumor measurements were done at 8 and 16 weeks after initiating treatment and then every 12 weeks and compared with baseline measurements prior to treatment. Measurements are continued until disease progression is documented or death.

What was measured

Progression-free Survival is defined as the duration alive from study entry until progression is documented, or death; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.

Analysis population: Eligible Patients

Groups in this outcome

Everolimus and Letrozole

Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.

Tamoxifen and Medroxyprogesterone Acetate

Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.

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

Analysis denominator · Participants

GroupSource count
Everolimus and Letrozole37
Tamoxifen and Medroxyprogesterone Acetate37

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus and Letrozole6.4Not reported3.817.7Not reported
Tamoxifen and Medroxyprogesterone Acetate3.7Not reported2.58.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.8
        upper Limit
        17.7
        value
        6.4
      2. group Id
        OG001
        lower Limit
        2.5
        upper Limit
        8.9
        value
        3.7
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    2. group Id
      OG001
      value
      37
    units
    Participants
description
Progression-free Survival is defined as the duration alive from study entry until progression is documented, or death; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.
    id
    OG000
    title
    Everolimus and Letrozole
  2. description
    Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
    id
    OG001
    title
    Tamoxifen and Medroxyprogesterone Acetate
param Type
MEDIAN
population Description
Eligible Patients
reporting Status
POSTED
time Frame
Tumor measurements were done at 8 and 16 weeks after initiating treatment and then every 12 weeks and compared with baseline measurements prior to treatment. Measurements are continued until disease progression is documented or death.
title
Median Progression-free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice