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NCT00068250 · OUTCOME

Phase II: Progression-free Survival (Including Phase I Patients at Same Dose)

Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma · Source last updated 2018-02-07

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

Measure
MEDIAN
Unit
years
Interval / dispersion
95% Confidence Interval
Time frame
Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.

What was measured

Progression is defined as greater than 25% increase in enhancing tumor or the appearance of new lesions in the brain, eye, or the appearance of a new positive cerebrospinal fluid (CSF) cytology. The patient may be neurologically stable or worse and on stable or increasing doses of corticosteroid. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )

Analysis population: Eligible patients on Temozolomide 100 mg arms who started study treatment

Groups in this outcome

Combined Temozolomide 100mg Arms

Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg

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

Analysis denominator · Participants

GroupSource count
Combined Temozolomide 100mg Arms53

Reported measurements

Source class 1
Values in years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combined Temozolomide 100mg Arms5.4Not reported1.87.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        7.3
        value
        5.4
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    units
    Participants
description
Progression is defined as greater than 25% increase in enhancing tumor or the appearance of new lesions in the brain, eye, or the appearance of a new positive cerebrospinal fluid (CSF) cytology. The patient may be neurologically stable or worse and on stable or increasing doses of corticosteroid. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
dispersion Type
95% Confidence Interval
groups
  1. description
    Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
    id
    OG000
    title
    Combined Temozolomide 100mg Arms
param Type
MEDIAN
population Description
Eligible patients on Temozolomide 100 mg arms who started study treatment
reporting Status
POSTED
time Frame
Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.
title
Phase II: Progression-free Survival (Including Phase I Patients at Same Dose)
type
SECONDARY
unit Of Measure
years

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

Preserved source evidence · Not medical advice