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NCT00941070 · OUTCOME

Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines.

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
post therapy at 3 months

What was measured

To quantitate change in pre-treatment standard uptake value (SUV) on PET/CT and posttreatment PET/CT or disease progression PET/CT. Change in PET/CT SUV will be associated with 3-month best overall clinical response.

Analysis population: 1 patient was non-compliant and received no therapy. Pt was excluded from analyses. 1 patient died from an unrelated health event after completing radiation and experimental chemotherapy and did not undergo 3-month F-18 FDG study.

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)24

Reported measurements

Pretherapy SUV
Values in Standard uptake value (SUV) · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Treatment (Cisplatin, Triapine, Radiation Therapy)14.6Not reported12.117.7Not reported
Posttherapy SUV
Values in Standard uptake value (SUV) · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Treatment (Cisplatin, Triapine, Radiation Therapy)2.6Not reported2.03.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.1
        upper Limit
        17.7
        value
        14.6
    title
    Pretherapy SUV
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        3.4
        value
        2.6
    title
    Posttherapy SUV
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
To quantitate change in pre-treatment standard uptake value (SUV) on PET/CT and posttreatment PET/CT or disease progression PET/CT. Change in PET/CT SUV will be associated with 3-month best overall clinical response.
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
1 patient was non-compliant and received no therapy. Pt was excluded from analyses. 1 patient died from an unrelated health event after completing radiation and experimental chemotherapy and did not undergo 3-month F-18 FDG study.
reporting Status
POSTED
time Frame
post therapy at 3 months
title
Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines.
type
PRIMARY
unit Of Measure
Standard uptake value (SUV)

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

Preserved source evidence · Not medical advice