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NCT00068250 · OUTCOME

Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From start of treatment to 10 weeks if RT received, to 15 weeks if not.

What was measured

Tumor response was centrally reviewed. Complete response: Disappearance of all enhancing tumor, the patient must be off steroid therapy and neurologically stable or improved; partial response: ≥ 50% decrease in enhancing tumor; progressive disease: ≥ 25% increase in a lesion, progressive or newly emergent meningeal or ocular disease. (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 and have scans for central review

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 Arms35

Reported measurements

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combined Temozolomide 100mg Arms18Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combined Temozolomide 100mg Arms12Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combined Temozolomide 100mg Arms2Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combined Temozolomide 100mg Arms3Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    RTOG 93-10 reported a pre-irradiation chemotherapy complete response rate of 59%. A chi-square test with a 0.20 one-sided significance level provides 81% power to detect the difference between a null hypothesis complete response rate of 59% and the alternative rate of 71% (a 20% increase) for the planned sample size of 52 patients.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.82
    statistical Comment
    One-sample test of proportions
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Description
    RTOG 93-10 reported a pre-irradiation chemotherapy complete response rate of 59%. A chi-square test with a 0.20 one-sided significance level provides 81% power to detect the difference between a null hypothesis complete response rate of 59% and the alternative rate of 71% (a 20% increase) for the planned sample size of 52 patients.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.82
    statistical Comment
    One-sample test of proportions
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Progressive Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Not evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Tumor response was centrally reviewed. Complete response: Disappearance of all enhancing tumor, the patient must be off steroid therapy and neurologically stable or improved; partial response: ≥ 50% decrease in enhancing tumor; progressive disease: ≥ 25% increase in a lesion, progressive or newly emergent meningeal or ocular disease. (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. )
groups
  1. description
    Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
    id
    OG000
    title
    Combined Temozolomide 100mg Arms
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible patients on Temozolomide 100 mg arms who started study treatment and have scans for central review
reporting Status
POSTED
time Frame
From start of treatment to 10 weeks if RT received, to 15 weeks if not.
title
Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice