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NCT00103259 · OUTCOME

Response Rate on Step 2

Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2014-05-23

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Tumor response was assessed after every 2 cycles until progression or intolerable toxicity with maximum of 3 years

What was measured

Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.

Analysis population: 10 eligible and treated patients who progressed on bortezomib and crossed over to bortezomib and irinotecan arm were included in the analysis

Groups in this outcome

Cross-over From Bortezomib to Combined Arm

Patients progressed on bortezomib in step 1 crossed over to the combination arm. Response rate is evaluated in these patients.

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

Analysis denominator · Participants

GroupSource count
Cross-over From Bortezomib to Combined Arm10

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Cross-over From Bortezomib to Combined Arm0Not reported025.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        25.9
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
dispersion Type
90% Confidence Interval
groups
  1. description
    Patients progressed on bortezomib in step 1 crossed over to the combination arm. Response rate is evaluated in these patients.
    id
    OG000
    title
    Cross-over From Bortezomib to Combined Arm
param Type
NUMBER
population Description
10 eligible and treated patients who progressed on bortezomib and crossed over to bortezomib and irinotecan arm were included in the analysis
reporting Status
POSTED
time Frame
Tumor response was assessed after every 2 cycles until progression or intolerable toxicity with maximum of 3 years
title
Response Rate on Step 2
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice