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NCT00354887 · OUTCOME

Number of Participants With Overall Response

Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater · Source last updated 2012-10-29

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses

What was measured

Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.

Analysis population: Analysis was intent-to-treat; One patient developed an acute flare of Crohn's disease after one cycle of study treatment and was removed from study without undergoing restaging scans.

Groups in this outcome

Oxaliplatin + Capecitabine

Intravenous Oxaliplatin 130 mg/m\^2, Day 1 + Oral Capecitabine 750 mg/m\^2 twice daily Days 1-14.

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

Analysis denominator · Participants

GroupSource count
Oxaliplatin + Capecitabine30

Reported measurements

Participants with CR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oxaliplatin + Capecitabine3Not reportedNot reportedNot reportedNot reported
Participants with PR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oxaliplatin + Capecitabine12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Participants with CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Participants with PR
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.
groups
  1. description
    Intravenous Oxaliplatin 130 mg/m\^2, Day 1 + Oral Capecitabine 750 mg/m\^2 twice daily Days 1-14.
    id
    OG000
    title
    Oxaliplatin + Capecitabine
param Type
NUMBER
population Description
Analysis was intent-to-treat; One patient developed an acute flare of Crohn's disease after one cycle of study treatment and was removed from study without undergoing restaging scans.
reporting Status
POSTED
time Frame
Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses
title
Number of Participants With Overall Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice