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NCT00941070 · OUTCOME

PET/CT Scan Metabolic Activity

Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer · Source last updated 2017-11-17

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

Measure
MEDIAN
Unit
Standard Uptake Value (SUV)
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline (pre-therapy)

What was measured

Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.

Analysis population: Patients that completed the 3-month 18F-FDG PET/CT

Groups in this outcome

Treatment (Cisplatin, Triapine, Radiation Therapy)

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated. Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

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

Analysis denominator · Participants

GroupSource count
Treatment (Cisplatin, Triapine, Radiation Therapy)25

Reported measurements

Source class 1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Treatment (Cisplatin, Triapine, Radiation Therapy)14.6Not reported12.117.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.1
        upper Limit
        17.7
        value
        14.6
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated. Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.
    id
    OG000
    title
    Treatment (Cisplatin, Triapine, Radiation Therapy)
param Type
MEDIAN
population Description
Patients that completed the 3-month 18F-FDG PET/CT
reporting Status
POSTED
time Frame
Baseline (pre-therapy)
title
PET/CT Scan Metabolic Activity
type
SECONDARY
unit Of Measure
Standard Uptake Value (SUV)

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

Preserved source evidence · Not medical advice