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NCT00028002 · OUTCOME

Rates of Objective Response (Complete, Partial, and Stable)

Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor · Source last updated 2020-10-26

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
95% Confidence Interval
Time frame
Pretreatment and prior to surgery (at 4-10 weeks, based on surgery timing)

What was measured

The percentage of patients who achieved a complete, partial or stable response prior to surgery as assessed by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist\_guideline.pdf.

Analysis population: Eligible patients who started study treatment

Groups in this outcome

Imatinib Mesylate

Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.

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

Analysis denominator · Participants

GroupSource count
Imatinib Mesylate52

Reported measurements

Complete Response
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Imatinib Mesylate0Not reported00Not reported
Partial Response
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Imatinib Mesylate5.8Not reported1.215.9Not reported
Stable Disease
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Imatinib Mesylate86.5Not reported74.294.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        15.9
        value
        5.8
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.2
        upper Limit
        94.4
        value
        86.5
    title
    Stable Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    units
    Participants
description
The percentage of patients who achieved a complete, partial or stable response prior to surgery as assessed by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist\_guideline.pdf.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
    id
    OG000
    title
    Imatinib Mesylate
param Type
NUMBER
population Description
Eligible patients who started study treatment
reporting Status
POSTED
time Frame
Pretreatment and prior to surgery (at 4-10 weeks, based on surgery timing)
title
Rates of Objective Response (Complete, Partial, and Stable)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice