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NCT00433550 · OUTCOME

Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)

Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer · Source last updated 2017-08-24

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

Measure
NUMBER
Unit
proportion of patients
Interval / dispersion
95% Confidence Interval
Time frame
36 weeks

What was measured

Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.

Analysis population: One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.

Groups in this outcome

All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)

Group 1 (6/6 UGT1A1 genotype): Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15 Group 2 (6/7 UGT1A1 genotype): Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15. Group 3 (7/7 UGT1A1 genotype): Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15

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

Analysis denominator · Participants

GroupSource count
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)32

Reported measurements

Source class 1
Values in proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype).38Not reported.21.56Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        .21
        upper Limit
        .56
        value
        .38
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
dispersion Type
95% Confidence Interval
groups
  1. description
    Group 1 (6/6 UGT1A1 genotype): Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15 Group 2 (6/7 UGT1A1 genotype): Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15. Group 3 (7/7 UGT1A1 genotype): Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
    id
    OG000
    title
    All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
param Type
NUMBER
population Description
One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.
reporting Status
POSTED
time Frame
36 weeks
title
Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)
type
PRIMARY
unit Of Measure
proportion of patients

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

Preserved source evidence · Not medical advice