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NCT00433550 · OUTCOME

Duration of 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 2 years

What was measured

Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods.

Analysis population: All patients who achieved a CR or PR are included in this analysis.

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)12

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)9.0Not reported7.8NAToo few events have occurred to estimate the upper 95% Confidence Interval.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Too few events have occurred to estimate the upper 95% Confidence Interval.
        group Id
        OG000
        lower Limit
        7.8
        upper Limit
        NA
        value
        9.0
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods.
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
MEDIAN
population Description
All patients who achieved a CR or PR are included in this analysis.
reporting Status
POSTED
time Frame
Up to 2 years
title
Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice