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NCT00553150 · OUTCOME

Time to Progression (Phase II)

Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma · Source last updated 2020-02-13

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
Up to 5 years

What was measured

Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy. Patients who experience major treatment violations will be censored for progression on the date of treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.

Groups in this outcome

Phase II

Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.

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

Analysis denominator · Participants

GroupSource count
Phase II100

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II6.4Not reported5.49.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.4
        upper Limit
        9.0
        value
        6.4
denoms
  1. counts
    1. group Id
      OG000
      value
      100
    units
    Participants
description
Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy. Patients who experience major treatment violations will be censored for progression on the date of treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
    id
    OG000
    title
    Phase II
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 5 years
title
Time to Progression (Phase II)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice