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NCT01595061 · OUTCOME

Complete Clinical Response

Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva · Source last updated 2021-12-29

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
90% Confidence Interval
Time frame
6-8 weeks after completion of chemo-radiation

What was measured

Percentage of participants with complete clinical response. Complete clinical response is defined as no clinical/radiographic evidence of primary disease (vulva or groin) following primary chemo-radiation therapy.

Analysis population: Eligible and Treated

Groups in this outcome

GEM+CIS+IMRT

Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.

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

Analysis denominator · Participants

GroupSource count
GEM+CIS+IMRT53

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT71.7Not reported6082Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        60
        upper Limit
        82
        value
        71.7
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    units
    Participants
description
Percentage of participants with complete clinical response. Complete clinical response is defined as no clinical/radiographic evidence of primary disease (vulva or groin) following primary chemo-radiation therapy.
dispersion Type
90% Confidence Interval
groups
  1. description
    Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
    id
    OG000
    title
    GEM+CIS+IMRT
param Type
NUMBER
population Description
Eligible and Treated
reporting Status
POSTED
time Frame
6-8 weeks after completion of chemo-radiation
title
Complete Clinical Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice